Data Set Name: basedata.sas7bdat - NIDDK Central Repository · 2016. 4. 7. · 5 PATIENT_TYPE Num 8...

04:40 Tuesday, February 09, 2016 1

Data Set Name: basedata.sas7bdat Num Variable Type Len Format Informat Label

1 IMMUN_CONSNT Num 8 IMM/VIR Consent (1=Yes, 2=No)

2 QUANT_CONSNT Num 8 QLFT Consent (1=Yes, 2=No)

3 COG_CONSNT Num 8 Cognitive Consent (1=Yes, 2=No)

4 GENE_TESTING Num 8 Genetic Consent (1=Yes, 2=No)

5 PATIENT_TYPE Num 8 PTTYPEF. 2. Patient type (1='LEAD' 2='EXPR' 3='BT' 4='RELAP')

6 RAND_GRP Num 8 Randomization group (1=treatment, 2=control)

7 NEWSTAT Num 8 Status (1=lead-in only, 2=Responder, 3=rand lead-in, 4=rand BT/Rel, 5= rand express)

8 AGE Num 8 Age at enrollment in years

9 RAND_DAYS Num 8 Number of days from enrollment to randomization

10 AGE_RAND Num 8 Age at randomization in years

11 RIBAVIRIN Num 8 Previous combination (interferon and ribavirin) therapy (1=Yes,0=No)

12 PEGINF Num 8 Previous pegylated interferon (1=Yes,0=No)

13 FEMALE Num 8 Female (Yes=1; No=0)

14 HISP Num 8 Hispanic (Yes=1; No=0)

15 WHITE Num 8 White-non-hispanic (Yes=1; No=0)

16 BLACK Num 8 Black or black + hisp (Yes=1; No=0)

17 OTHERS Num 8 Other race (Yes=1; No=0)

18 DIABETES Num 8 FO03: Has a Doctor told patient has diabetes (Yes=1, No=0)

19 inel_psy Num 8 FO03: Yes for one of the psychological questions B33-B36 (Yes=1, No/missing=.)

20 IRON Num 8 X582F. 4. Iron (mcg/dL) at baseline

21 IRON_BIN Num 8 X582F. 4. Total iron binding capacity (TIBC, mcg/dL) at baseline

22 SER_FERR Num 8 X582F. 6. Serum ferritin (ng/mL) at baseline

23 iron_sat Num 8 Iron saturation (iron (mcg/dL) /total iron binding capacity (mcg/dL) ) at baseline

24 FER_LOG Num 8 Log serum ferritin (ng/mL) at baseline

25 DRUG_INJ Num 8 3. F06B2f. Tested history inj drug use (1=Yes, 0=No)

26 TRANS_REC Num 8 3. F06B3. Ever received a transfusion (1=Yes, 0=No)

27 HUM_BLOOD Num 8 3. F06B4. Ever exposed to human blood job (1=Yes, 0=No)

28 NEEDLE_STICK Num 8 3. F06B5. Ever experience needlestick (1=Yes, 0=No)

29 REC_DRUGS Num 8 3. F06B8. Ever used needles recr drugs (1=Yes, 0=No)

30 WAIST_CM Num 8 X582F. 4. Waist circumference in cms at baseline

31 BP1 Num 8 X582F. 4. Systolic blood pressure at baseline

32 BP2 Num 8 X582F. 4. Diastolic blood pressure at baseline

33 PULSE Num 8 X582F. 4. Pulse at baseline (set to missing when pulse < 20 or >= 180)

34 HEPATO Num 8 3. Hepatomegaly at baseline (1=Yes, 0=No)

35 SPLEEN Num 8 3. Spleen palpable at baseline (1=Yes, 0=No)


Num Variable Type Len Format Informat Label 36 EDEMA Num 8 3. Edema physical exam at baseline (1=Yes, 0=No)

37 WEIGHTC_KG Num 8 Weight in kgs at baseline

38 HEIGHTC_CM Num 8 Height in cms at baseline

39 BMI Num 8 Body Mass Index at baseline (weight (kg)/height(m)^2)

40 SPLENO Num 8 3. Ultrasound:Evidence of splenomegaly (1=Yes, 0=No)

41 SPLEEN_SIZE Num 8 X582F. 3. Ultrasound: Length of spleen, if splenomegaly (>13 cm)

42 F14_PERF Num 8 liver tissue collected at baseline (Yes=1, No=2).

43 EVERDRANK Num 8 Ever Drank? (Lifetime)(1=Yes, 0=No)

44 LIFE_DRINKS Num 8 Total number of drinks lifetime

45 AVE_GRAMS_P_D Num 8 Av gms of alcohol/day

46 BDI_SCORE Num 8 Beck BDI Depression score

47 depr_score Num 8 BDI Depression (1=<11, 2=11-4, 3=15-19, 4=20-28, 5=>28)

48 depr15 Num 8 BDI Depression >= 15 (1=Yes, 0=No)

49 MARITAL Num 8 X472F. 3. FO45: B1. Current marital status

50 EMPL_STATUS Num 8 X544F. 3. Employment status

51 UNEMPLOYED Num 8 X470F. 3. Status if unemployed

52 HEALTH_REAS Num 8 X550F. 3. Work status changed because of health

53 INS_MEDAID Num 8 X558F. 3. Health insurance - Medicaid

54 INS_MEDICARE Num 8 X558F. 3. Health insurance - Medicare

55 INS_HMO Num 8 X558F. 3. Health insurance - HMO

56 INS_PRIVATE Num 8 X558F. 3. Health insurance - Private

57 INS_OTHER Num 8 X558F. 3. Health insurance - Other

58 MARRIED Num 8 Marital status- Married (Yes=1, No=0)

59 BIOPSY_SPEC Num 8 X550F. 3. FO50: B3. Biopsy performed specifically for the trial?

60 ISH_SCO Num 8 X411F. 3. Local Ishak Fibrosis score(1-3)

61 STEATO_H Num 8 X550F. 3. FO50: C4. Steatohepatitis (no longer an exclusion)

62 ISHAK_SCORE Num 8 X582F. 3. Ishak Fibrosis (0-6)

63 prev_ish1 Num 8 FO50: C3c. Ishak Fibrosis score of previous biopsy-1st repeating segment

64 SPEC_LENGTH Num 8 X582F. 5.1 specimen length at screening biopsy

65 ADEQUATE Num 8 X550F. 3. FO51: B4. Adequate for grading and staging at screening biopsy (Yes=1, No=2)?

66 PERI_ISHAK Num 8 X582F. 3. Periportal-ishak score at screening biopsy

67 PERI_KNODELL Num 8 X582F. 3. periportal-knodell score at screening biopsy

68 CONFLU_ISHAK Num 8 X582F. 3. Confluent necrosis-ishak score at screening biopsy

69 PAREN_ISHAK Num 8 X582F. 3. Parenchymal injury-ishak score at screening biopsy

70 PAREN_KNODEL Num 8 X582F. 3. Parenchymal injury-knodell score at screening biopsy

71 PORTAL_ISHAK Num 8 X582F. 3. Portal inflammation-ishak score at screening biopsy

72 PORTAL_KNODE Num 8 X582F. 3. Portal inflammation-knodell score at screening biopsy


Num Variable Type Len Format Informat Label 73 INFLAM_METAV Num 8 X582F. 3. Inflammatory activity-metavir score at screening biopsy

74 FIBRO_ISHAK Num 8 X582F. 3. Fibrosis-ishak score at screening biopsy

75 FIBRO_KNODEL Num 8 X582F. 3. Fibrosis-knodell score at screening biopsy

76 FIBRO_METAVI Num 8 X582F. 3. Fibrosis-metavir score at screening biopsy

77 FAT Num 8 X402F. 3. Fat (0-4) at screening biopsy

78 IRON_GRADE Num 8 X582F. 3. Hepatocellular iron grade at screening biopsy

79 HAI Num 8 Histology Activity Index at screening biopsy

80 INFLA_ISHAK Num 8 Ishak inflammation score at screening biopsy

81 MALLORY_GR Num 8 Mallory bodies (0-2) at screening biopsy

82 ZONE3_PERI_FIB Num 8 Zone 3 peri. fib.(0-2) at screening biopsy

83 MALLORY_YN Num 8 Mallory bodies (0-1) at screening biopsy

84 FATCAT Num 8 Hepatic steatosis S00 (2 categories - 0: 0-1, 1: 2-4) at screening biopsy

85 FAT0_3 Num 8 FATCATF. Hepatic steatosis S00 (4 categories - 0,1,2,3-4) at screening biopsy

86 fragmented Num 8 Fragmented biopsy at screening (Yes=1, No=0)

87 INSULIN Num 8 Insulin uU/ml at baseline

88 GLYSOLATED Num 8 X582F. 5.1 F121: B1. Level of glycosylated hemoglobin?

89 AGE_QUIT Num 8 X582F. 3. F142A Age when quit

90 SMOKE_CIG_NOW Num 8 F142 Smoke cigarettes now (Yes=1, No=0)

91 SMOKESTAT Num 8 F142 Smoking (1=Never;2=Not now;3=Now <1pack/day;4= Now >=1pack/day)

92 AGE_START Num 8 F142 Age started smoking cigarettes

93 PACKYEARS Num 8 F142 Packyears of cigarettes

94 NSAID Num 8 F141 NSAID within 12 mos (1=Yes, 0=No)

95 ANTIDIAB_B Num 8 Meds: Antidiabetics at baseline (Yes=1; No/missing=0)

96 INSULIN_B Num 8 Meds: Insulin injection at baseline (Yes=1; No/missing=0)

97 ANY_ANTIHYP_B Num 8 Any anti-hypertensive at baseline (Yes=1; No/missing=0)

98 B_BLOCK_B Num 8 Beta Blocker anti-hyp. at baseline (Yes=1; No/missing=0)

99 CC_BLOCK_B Num 8 Calcium Channel Blocker anti-hyp. at baseline (Yes=1; No/missing=0)

100 ACE_I_B Num 8 ACE inhibitor anti-hyp. at baseline (Yes=1; No/missing=0)

101 DIUR_Z_B Num 8 Thiazide diuretic anti-hyp. at baseline (Yes=1; No/missing=0)

102 PH_B Num 8 Portal hypertension at baseline (Yes=1; No/missing=0)

103 ANX_DRUG_B Num 8 Anxiolytic at baseline (Yes=1; No/missing=0)

104 DEP_SSRI_B Num 8 SSRI antidepressant at baseline (Yes=1; No/missing=0)

105 DEP_NOT_SSRI_B Num 8 Non-SSRI antidepressant at baseline (Yes=1; No/missing=0)

106 ANY_DEP_ANX_B Num 8 Antidepressant/anxiolytic at baseline (Yes=1; No/missing=0)

107 NSAID_B Num 8 Meds: RX NSAID at baseline (Yes=1; No/missing=0)

108 COX2_B Num 8 Meds: RX Cox2 Inhibitors at baseline (Yes=1; No/missing=0)

109 HCVRNAP_W20 Num 8 HCR RNA POSITIVE W20, if tested (0=No, 1= Yes)


Num Variable Type Len Format Informat Label 110 HCVRNAP_W60 Num 8 HCR RNA POSITIVE W60, if tested (0=No, 1= Yes)

111 HCVRNAP_W72 Num 8 HCR RNA POSITIVE W72, if tested (0=No, 1= Yes)

112 W20VR Num 8 Week 20 virologic response (1=Yes, 0=No)

113 SPLENECTOMY Num 8 Patient had splenectomy (Yes=1; No/missing=.)

114 HAS_SPLEEN Num 8 Patient has spleen (Yes=1; No/missing=.)

115 HOMA2IR2 Num 8 BEST16. 16. The updated homeostasis model assessment (HOMA 2 IR).

116 wbc Num 8 Baseline WBC x1000/mm3

117 neutrophils Num 8 Baseline Neutrophils x1000/mm3

118 hematocrit Num 8 Baseline Hematocrit, %

119 hemoglobin Num 8 Baseline Hemoglobin, g/dL

120 platelets Num 8 Baseline Platelets x1000/mm3

121 bun Num 8 Baseline BUN, mg/dL

122 creatinine Num 8 Baseline Creatinine, mg/dl

123 glucose Num 8 Baseline Glucose, mg/dL

124 triglyceride Num 8 Baseline Triglycerides,mg/dL

125 uric_acid Num 8 Baseline Uric acid, mg/dL

126 ast Num 8 Baseline AST, U/L

127 upper_ast Num 8 Upper limit of normal AST at baseline (U/L).

128 alt Num 8 Baseline ALT, U/L

129 upper_alt Num 8 Upper limit of normal ALT at baseline (U/L).

130 alkaline Num 8 Baseline Alkaline phosphatase, U/L

131 upper_alkali Num 8 Upper limit of normal alkaline at baseline (U/L).

132 tot_bilirubi Num 8 Baseline Total bilirubin, mg/dL

133 albumin Num 8 Baseline Albumin, g/dL

134 prothrombin Num 8 Baseline Prothrombin time,INR

135 pregnant Num 8 (Baseline) Pregnant (1=positive, 2=negative)?

136 count Num 8 Baseline HCV RNA (IU/mL)

137 logcount Num 8 Baseline Log HCV RNA (IU/mL)

138 afp Num 8 Baseline AFP, ng/ml

139 afp_norm Num 8 Upper limit of normal AFT at baseline (ng/ml)

140 TRIG_GT_200 Num 8 Baseline Triglyceride > 200 (=1 if triglyceride >200; =0 if Triglyceride = 200)

141 ALT_RATIO Num 8 Baseline ALT ratio to upper limit of normal

142 AST_RATIO Num 8 Baseline AST ratio to upper limit of normal

143 AST_ALT Num 8 Baseline AST/ALT

144 ALKPHOS_RATIO Num 8 Baseline Alk phos ratio upper limit of normal

145 aprinew Num 8 Baseline 100 X ast/ULN/platelets

146 MAP Num 8 Baseline Mean arterial pressure(Dia + 1/3(Sys-Dia)

147 ever_smoke Num 8 Ever smoked (Yes=1, No=0)


Num Variable Type Len Format Informat Label 148 MELD Num 8 MELD Model, UNOS Modification

149 geno1s Num 8 Genotype 1 (1=Yes, 0=No) by any method

150 yr_ifn_bx Num 8 Years from last dose IFN to screening biopsy

151 IFN_BX_GT_6MOS Num 8 Last IFN > 6 mos before screening biopsy (=1 if last IFN >6 mos; =0 if last IFN = 6mos)

152 NO_CAUSE Num 8 No exposures reported form 6 (1=Yes, 0=No)

153 CIRRHOSIS Num 8 Cirrhosis on biopsy (Ishak 5-6) (1=Yes, 0=No)

154 highglucose Num 8 Glucose >=126 (1=Yes, 0=No)

155 highsugar Num 8 Glucose >= 126/diabetes (1=Yes, 0=No)

156 EDUCATION Num 8 EDUCF. F06/F45. Coded education

157 COLLEGE Num 8 At least some college (1=Yes, 0=No)

158 collgrad Num 8 College grad (1=Yes, 0=No)

159 hghscgrad Num 8 HS grad (1=Yes, 0=No)

160 HOMANEW Num 8 Homeostasis Model Assessment (adjusted)

161 DURINF Num 8 Duration of infection in years, MD assessment

162 LOGODDS Num 8 Predicting cirrhosis model equation (LOK)

163 PREDPROB Num 8 Predicted cirrhosis probability using (LOK) formula.

164 TRUNOBS2COM Num 8 Truncal obesity: waist circumference (high vs. normal) for male & female (0=Yes, 1=No)

165 WHRATIO Num 8 Waist-to-Height Ratio

166 DRINKS_BASE Num 8 Has had alchohol in past six months (R00 and W00 combined) (1=Yes, 0=No)

167 DRINKS3CATE Num 8 DRINKC. Drinking at baseline: Never / Past but not currently / Currently

168 RACE4 Num 8 RACE4F. Race (White, Black, Hispanic, Other)

169 SMOKESTAT2 Num 8 SMOKE2F. F142 Smoking (0:Non-smoker;1:Current-smoker)

170 housesize Char 10 Total number of family members living in household

171 NEW_GENOTYPE Num 8 Genotype: 0=Not 1, 1=1a, 2=1a/1b, 3=1b, 4=1 nosub

172 GENO3S Num 8 Genotype 3 (1=Yes, 0=No) by any method

173 subj_id Num 8 Subject ID

174 ULTRA_DAYS Num 8 Days from enrollment to baseline ultrasound

175 COURSE_DAYS Num 8 Last interferon - days from enrollment

176 BIOPSY_DAYS Num 8 Days from enrollment to baseline biopsy (FO50: B2. Date of biopsy)

177 blood_days Num 8 Blood draw (FO30: A6. Date of Blood draw) - days from enrollment

178 blinded_siteID Num 8 Blinded site ID


Data Set Name: biopsies.sas7bdat

Num Variable Type Len Format Informat Label 1 NEWSTAT Num 8 Status (Lead/Resp/R_L/R_B/R_E)

2 BIOPSY_SPEC Num 8 X550F. 3. Was biopsy performed for HALT-C?

3 ISH_SCO Num 8 X411F. 3. Local Ishak Fibrosis score(1-3)

4 STEATO Num 8 X550F. 3. Local Steatohepatitis (Y/N)

5 HEPATO_IRON Num 8 X511F. 3. Local Hepatocellular iron (3+ or 4+)

6 ALPHA_1_ANTI Num 8 X511F. 3. Local Alpha-1-antitrypsin deficiency

7 STEATO_SEV Num 8 X550F. 3. Local,is steatosis severe? (Vers B,C)

8 ISHAK_SCORE Num 8 X582F. 3. Local Ishak Fibrosis (0-6)

9 FM50_VER_ID Char 1 $1. $1. Form50 version ID

10 visit_num Char 3 $4. $4. Visit number

11 SPEC_LENGTH Num 8 5.1 5.1 Specimen length

12 ADEQUATE Num 8 3. 3. Adequate biopsy (central)? 1=Yes, 2=No

13 PERI_ISHAK Num 8 3. 3. Periportal-ishak score

14 PERI_KNODELL Num 8 3. 3. Periportal-knodell score

15 CONFLU_ISHAK Num 8 3. 3. Confluent necrosis-ishak score

16 PAREN_ISHAK Num 8 3. 3. Parenchymal injury-ishak score

17 PAREN_KNODEL Num 8 3. 3. Parenchymal injury-knodell score

18 PORTAL_ISHAK Num 8 3. 3. Portal inflammation-ishak score

19 PORTAL_KNODE Num 8 3. 3. Portal inflammation-knodell score

20 INFLAM_METAV Num 8 3. 3. Inflammatory activity-metavir score

21 FIBRO_ISHAK Num 8 3. 3. Fibrosis-ishak score

22 FIBRO_KNODEL Num 8 3. 3. Fibrosis-knodell score

23 FIBRO_METAVI Num 8 3. 3. Fibrosis-metavir score

24 FAT Num 8 3. 3. Fat (0-4)

25 IRON_GRADE Num 8 3. 3. Hepatocellular iron grade

26 LARGE_CELL Num 8 3. 3. Large cell change (1=Present, 2=Absent)

27 SMALL_CELL Num 8 3. 3. Small cell change (1=Present, 2=Absent)

28 BILE_DUCT Num 8 3. 3. Bile duct lesions (1=Present, 2=Absent)

29 LYMPHOID Num 8 3. 3. Lymphoid follicles (1=Present, 2=Absent)

30 FORM51 Num 8 Have form 51 (1=yes)

31 OTH_FRAG Num 8 ’Fragmentation noted on Form 51 (1=yes)

32 HAI Num 8 Histology Activity Index

33 INFLA_ISHAK Num 8 Ishak inflammation score

34 MALLORY_GR Num 8 Mallory bodies (0=Absent, 1=Few, 2=Many)

35 ZONE3_PERI_FIB Num 8 Zone 3 pericellular fibrosis (0=Absent, 1=Mild, 2=Moderate/Marked)

36 MALLORY_YN Num 8 Mallory bodies (1=Yes, 1=No)


Num Variable Type Len Format Informat Label 37 FRAGMENTED Num 8 Biopsy coded as fragmented by ZG (1=yes)

38 BIOPSYAREA Num 8 9.4 9.4 Biopsy area

39 COLLAGEN Num 8 9.4 9.4 Amount of collagen

40 BIOP_ADE Num 8 3. 3. Biopsy adequate (site)? 1=Yes, 2=No


42 course_days Num 8 Days from enrollment to the date of last interferon

43 biopsy_days Num 8 Days from enrollment to the date of biospy

44 fm51_days Num 8 Days from enrollment to the date of central biopsy reading

45 rand_days Num 8 Days from enrollment to randomization


Data Set Name: labsnew.sas7bdat

Num Variable Type Len Format Informat Label 1 PATIENT_TYPE Num 8 PTTYPEF. 2. Patient type (LI,EXP,BT,REL)

2 NEWSTAT Num 8 Status (Lead/Resp/R_L/R_B/R_E)

3 FEMALE Num 8 Female

4 BLACK Num 8 Black or black + hisp

5 R00_VISIT Char 3 $3. $3. R00 visit number (S00 (express) or W36-W72)

6 DAY_S01 Num 8 Form 30 days from Randomization, S01

7 DAY_S02 Num 8 Form 30 days from Randomization, S02

8 DAY_W00 Num 8 Form 30 days from Randomization, W00














22 DAY_R00 Num 8 Form 30 days from Randomization, R00

23 DAY_M09 Num 8 Form 30 days from Randomization, M09















Num Variable Type Len Format Informat Label 37 DAY_M54 Num 8 Form 30 days from Randomization, M54










47 FHR_W72 Num 8 Fasting Status (hours fasting), W72

48 FHR_R00 Num 8 Fasting Status (hours fasting), R00

49 FHR_M09 Num 8 Fasting Status (hours fasting), M09















64 WBC_S01 Num 8 WBC, S01

65 WBC_W00 Num 8 WBC, W00












Num Variable Type Len Format Informat Label 76 WBC_W48 Num 8 WBC, W48



79 WBC_R00 Num 8 WBC, R00

80 WBC_M09 Num 8 WBC, M09






















102 WBC_M102 Num 8 WBC, M102

103 WBC_M108 Num 8 WBC, M108

104 ANC_S01 Num 8 ANC, S01

105 ANC_W00 Num 8 ANC, W00











Num Variable Type Len Format Informat Label 115 ANC_W42 Num 8 ANC, W42




119 ANC_R00 Num 8 ANC, R00

120 ANC_M09 Num 8 ANC, M09






















142 ANC_M102 Num 8 ANC, M102

143 ANC_M108 Num 8 ANC, M108

144 HEMAT_S01 Num 8 Hematocrit (%), S01

145 HEMAT_W00 Num 8 Hematocrit (%), W00










Num Variable Type Len Format Informat Label 154 HEMAT_W36 Num 8 Hematocrit (%), W36





159 HEMAT_R00 Num 8 Hematocrit (%), R00

160 HEMAT_M09 Num 8 Hematocrit (%), M09
























184 HEM_S01 Num 8 Hemoglobin (g/dL), S01

185 HEM_W00 Num 8 Hemoglobin (g/dL), W00









Num Variable Type Len Format Informat Label 193 HEM_W30 Num 8 Hemoglobin (g/dL), W30






199 HEM_R00 Num 8 Hemoglobin (g/dL), R00

200 HEM_M09 Num 8 Hemoglobin (g/dL), M09
























224 PLT_S01 Num 8 Platelets, S01

225 PLT_W00 Num 8 Platelets, W00








Num Variable Type Len Format Informat Label 232 PLT_W24 Num 8 Platelets, W24







239 PLT_R00 Num 8 Platelets, R00

240 PLT_M09 Num 8 Platelets, M09
























264 BUN_S01 Num 8 BUN (mg/dL), S01

265 BUN_W00 Num 8 BUN (mg/dL), W00





270 BUN_R00 Num 8 BUN (mg/dL), R00


Num Variable Type Len Format Informat Label 271 BUN_M12 Num 8 BUN (mg/dL), M12

272 BUN_M18 Num 8 BUN (mg/dL), M18






278 CRE_S01 Num 8 Creatinine (mg/dL), S01

279 CRE_W00 Num 8 Creatinine (mg/dL), W00





284 CRE_R00 Num 8 Creatinine (mg/dL), R00

285 CRE_M12 Num 8 Creatinine (mg/dL), M12
















301 GLU_S01 Num 8 Glucose (mg/dL), S01

302 GLU_W00 Num 8 Glucose (mg/dL), W00





307 GLU_R00 Num 8 Glucose (mg/dL), R00

308 GLU_M12 Num 8 Glucose (mg/dL), M12



Num Variable Type Len Format Informat Label 310 GLU_M24 Num 8 Glucose (mg/dL), M24





315 TRIGL_S01 Num 8 Triglycerides (mg/dL), S01

316 TRIGL_W00 Num 8 Triglycerides (mg/dL), W00





321 TRIGL_R00 Num 8 Triglycerides (mg/dL), R00

322 TRIGL_M12 Num 8 Triglycerides (mg/dL), M12







329 GFR_S01 Num 8 Glomular Filtration Rate (eGFR), S01

330 GFR_W00 Num 8 Glomular Filtration Rate (eGFR), W00





335 GFR_R00 Num 8 Glomular Filtration Rate (eGFR), R00

336 GFR_M12 Num 8 Glomular Filtration Rate (eGFR), M12







343 AST_S01 Num 8 AST, S01

344 AST_S02 Num 8 AST, S02

345 AST_W00 Num 8 AST, W00





Num Variable Type Len Format Informat Label 349 AST_W16 Num 8 AST, W16









358 AST_R00 Num 8 AST (U/L), R00

359 AST_M09 Num 8 AST (U/L), M09






















381 AST_M102 Num 8 AST (U/L), M102

382 AST_M108 Num 8 AST (U/L), M108

383 UPPER_AST_S01 Num 8 AST ULN, S01

384 UPPER_AST_S02 Num 8 AST ULN, S02

385 UPPER_AST_W00 Num 8 AST ULN, W00




Num Variable Type Len Format Informat Label 388 UPPER_AST_W12 Num 8 AST ULN, W12










398 UPPER_AST_R00 Num 8 AST ULN, R00

399 UPPER_AST_M09 Num 8 AST ULN, M09















414 UPPER_AST_M60 Num 8 ST ULN, M60









423 AST_NORM_S01 Num 8 AST Normal, S01

424 AST_NORM_S02 Num 8 AST Normal, S02

425 AST_NORM_W00 Num 8 AST Normal, W00



Num Variable Type Len Format Informat Label 427 AST_NORM_W08 Num 8 AST Normal, W08











438 AST_NORM_R00 Num 8 AST Normal, R00

439 AST_NORM_M09 Num 8 AST Normal, M09
























463 AST_RATIO_S01 Num 8 AST ratio to ULN, S01

464 AST_RATIO_S02 Num 8 AST ratio to ULN, S02

465 AST_RATIO_W00 Num 8 AST ratio to ULN, W00


Num Variable Type Len Format Informat Label 466 AST_RATIO_W04 Num 8 AST ratio to ULN, W04












478 AST_RATIO_R00 Num 8 AST ratio to ULN, R00

479 AST_RATIO_M09 Num 8 AST ratio to ULN, M09
























503 ALT_S01 Num 8 ALT(U/L), S01

504 ALT_S02 Num 8 ALT(U/L), S02


Num Variable Type Len Format Informat Label 505 ALT_W00 Num 8 ALT(U/L), W00

506 ALT_W04 Num 8 ALT(U/L), W04












518 ALT_R00 Num 8 ALT(U/L), R00

519 ALT_M09 Num 8 ALT (U/L), M09






















541 ALT_M102 Num 8 ALT (U/L), M102

542 ALT_M108 Num 8 ALT (U/L), M108

543 UPPER_ALT_S01 Num 8 ALT ULN, S01


Num Variable Type Len Format Informat Label 544 UPPER_ALT_S02 Num 8 ALT ULN, S02

545 UPPER_ALT_W00 Num 8 ALT ULN, W00













558 UPPER_ALT_R00 Num 8 ALT ULN, R00

559 UPPER_ALT_M09 Num 8 ALT ULN, M09

























Num Variable Type Len Format Informat Label 583 ALT_RATIO_S01 Num 8 ALT ratio to ULN, S01

584 ALT_RATIO_S02 Num 8 ALT ratio to ULN, S02

585 ALT_RATIO_W00 Num 8 ALT ratio to ULN, W00













598 ALT_RATIO_R00 Num 8 ALT ratio to ULN, R00

599 ALT_RATIO_M09 Num 8 ALT ratio to ULN, M09
























Num Variable Type Len Format Informat Label 622 ALT_RATIO_M108 Num 8 ALT ratio to ULN, M108

623 ALT_NORM_S01 Num 8 ALT Normal, S01

624 ALT_NORM_S02 Num 8 ALT Normal, S02

625 ALT_NORM_W00 Num 8 ALT Normal, W00













638 ALT_NORM_R00 Num 8 ALT Normal, R00

639 ALT_NORM_M09 Num 8 ALT Normal, M09























Num Variable Type Len Format Informat Label 661 ALT_NORM_M102 Num 8 ALT Normal, M102


663 AST_ALT_S01 Num 8 AST/ALT, S01

664 AST_ALT_S02 Num 8 AST/ALT, S02

665 AST_ALT_W00 Num 8 AST/ALT, W00













678 AST_ALT_R00 Num 8 AST/ALT, R00

679 AST_ALT_M09 Num 8 AST/ALT, M09






















Num Variable Type Len Format Informat Label 700 AST_ALT_M96 Num 8 AST/ALT, M96



703 ALK_S01 Num 8 Alkaline phosphatase (U/L) S01

704 ALK_S02 Num 8 Alkaline phosphatase (U/L) S02

705 ALK_W00 Num 8 Alkaline phosphatase (U/L) W00













718 ALK_R00 Num 8 Alkaline phosphatase (U/L) R00

719 ALK_M09 Num 8 Alkaline phosphatase (U/L) M09





















Num Variable Type Len Format Informat Label 739 ALK_M90 Num 8 Alkaline phosphatase (U/L) M90




743 UALK_S01 Num 8 Upper Alkaline phos, S01

744 UALK_S02 Num 8 Upper Alkaline phos, S02

745 UALK_W00 Num 8 Upper Alkaline phos, W00













758 UALK_R00 Num 8 Upper Alkaline phos, R00

759 UALK_M09 Num 8 Upper Alkaline phos, M09




















Num Variable Type Len Format Informat Label 778 UALK_M84 Num 8 Upper Alkaline phos, M84





783 ALKPHOS_RATIO_S01 Num 8 Alk phos ratio ULN, S01

784 ALKPHOS_RATIO_S02 Num 8 Alk phos ratio ULN, S02

785 ALKPHOS_RATIO_W00 Num 8 Alk phos ratio ULN, W00













798 ALKPHOS_RATIO_R00 Num 8 Alk phos ratio ULN, R00

799 ALKPHOS_RATIO_M09 Num 8 Alk phos ratio ULN, M09



















Num Variable Type Len Format Informat Label 817 ALKPHOS_RATIO_M78 Num 8 Alk phos ratio ULN, M78






823 BIL_S01 Num 8 Total Bilirubin (mg/dL), S01

824 BIL_S02 Num 8 Total Bilirubin (mg/dL), S02

825 BIL_W00 Num 8 Total Bilirubin (mg/dL), W00













838 BIL_R00 Num 8 Total Bilirubin (mg/dL), R00

839 BIL_M09 Num 8 Total Bilirubin (mg/dL), M09


















Num Variable Type Len Format Informat Label 856 BIL_M72 Num 8 Total Bilirubin (mg/dL), M72







863 ALB_S01 Num 8 Albumin (g/dL) S01

864 ALB_S02 Num 8 Albumin (g/dL) S02

865 ALB_W00 Num 8 Albumin (g/dL) W00













878 ALB_R00 Num 8 Albumin (g/dL) R00

879 ALB_M09 Num 8 Albumin (g/dL) M09

















Num Variable Type Len Format Informat Label 895 ALB_M66 Num 8 Albumin (g/dL) M66








903 GLOB_S01 Num 8 Globulin (g/dL), S01

904 GLOB_S02 Num 8 Globulin (g/dL), S02

905 GLOB_W00 Num 8 Globulin (g/dL), W00













918 GLOB_R00 Num 8 Globulin (g/dL), R00

919 GLOB_M09 Num 8 Globulin (g/dL), M09
















Num Variable Type Len Format Informat Label 934 GLOB_M60 Num 8 Globulin (g/dL), M60









943 TOTPRO_S01 Num 8 Total Protein (g/dL), S01

944 TOTPRO_S02 Num 8 Total Protein (g/dL), S02

945 TOTPRO_W00 Num 8 Total Protein (g/dL), W00













958 TOTPRO_R00 Num 8 Total Protein (g/dL), R00

959 TOTPRO_M09 Num 8 Total Protein (g/dL), M09















Num Variable Type Len Format Informat Label 973 TOTPRO_M54 Num 8 Total Protein (g/dL), M54










983 INR_S01 Num 8 Prothrombin Time (INR), S01

984 INR_W00 Num 8 Prothrombin Time (INR), W00







991 INR_R00 Num 8 Prothrombin Time (INR), R00

992 INR_M09 Num 8 Prothrombin Time (INR), M09





















Num Variable Type Len Format Informat Label 1012 INR_M90 Num 8 Prothrombin Time (INR), M90




1016 TSH_S02 Num 8 TSH (mU/L), S02

1017 TSH_W12 Num 8 TSH (mU/L), W12





1022 TSH_M12 Num 8 TSH (mU/L), M12







1029 UPR_S02 Num 8 Urinary Protein, S02

1030 UPR_W48 Num 8 Urinary Protein, W48

1031 UPR_M12 Num 8 Urinary Protein, M12




1035 UHE_S02 Num 8 Urinary Heme, S02

1036 UHE_W48 Num 8 Urinary Heme, W48

1037 UHE_M12 Num 8 Urinary Heme, M12




1041 AFP_S01 Num 8 Local AFP (ng/ml), S01

1042 AFP_W00 Num 8 Local AFP (ng/ml), W00






1048 AFP_R00 Num 8 Local AFP (ng/ml), R00

1049 AFP_M09 Num 8 Local AFP (ng/ml), M09



Num Variable Type Len Format Informat Label 1051 AFP_M15 Num 8 Local AFP (ng/ml), M15






















1073 AFPBBI_S01 Num 8 Central AFP (ng/mL) S01

1074 AFPBBI_W00 Num 8 Central AFP (ng/mL) W00







1081 AFPBBI_R00 Num 8 Central AFP (ng/mL) R00

1082 AFPBBI_M09 Num 8 Central AFP (ng/mL) M09









Num Variable Type Len Format Informat Label 1090 AFPBBI_M33 Num 8 Central AFP (ng/mL) M33







1097 AFP_NORM_S01 Num 8 Local AFP ULN, S01

1098 AFP_NORM_W00 Num 8 Local AFP ULN, W00







1105 AFP_NORM_R00 Num 8 Local AFP ULN, R00

1106 AFP_NORM_M09 Num 8 Local AFP ULN, M09
























Num Variable Type Len Format Informat Label 1129 AFP_NORM_M108 Num 8 Local AFP ULN, M108

1130 APRINEW_S01 Num 8 100 X ast/ULN/platelets, S01

1131 APRINEW_W00 Num 8 100 X ast/ULN/platelets, W00













1144 APRINEW_R00 Num 8 100 X ast/ULN/platelets, R00

1145 APRINEW_M09 Num 8 100 X ast/ULN/platelets, M09
























Num Variable Type Len Format Informat Label 1168 APRINEW_M108 Num 8 100 X ast/ULN/platelets, M108










1178 HEM_MIN Num 8 Hemoglobin (g/dL), MIN (through M48)

1179 PLT_MIN Num 8 Platelets, MIN (through M48)

1180 WBC_MIN Num 8 WBC, MIN (through M48)

1181 ANC_MIN Num 8 ANC, MIN (through M48)

1182 WBC_MAX Num 8 WBC, MAX (through M48)

1183 ANC_MAX Num 8 ANC, MAX (through M48)

1184 ALT_MAX Num 8 ALT (U/L), MAX (through M48)

1185 ALTR_MAX Num 8 ALT ratio to ULN, MAX (through M48)

1186 UPPER_ALT_MAX Num 8 ALT ULN, MAX (through M48)

1187 AST_MAX Num 8 AST (U/L), MAX (through M48)

1188 ASTR_MAX Num 8 AST ratio to ULN, MAX (through M48)

1189 UPPER_AST_MAX Num 8 AST ULN, MAX (through M48)

1190 AST_ALT_MAX Num 8 AST/ALT, MAX (through M48)

1191 ALKPHOS_MAX Num 8 Alkaline phosphatase (U/L) Max

1192 ALB_MIN Num 8 Albumin (g/dL) MIN (through M48)

1193 BIL_MAX Num 8 Total Bilirubin (mg/dL), MAX (through M48)

1194 INR_MAX Num 8 Prothrombin Time (INR), MAX (through M48)

1195 TSH_MAX Num 8 TSH (mU/L), MAX (through M48)

1196 TSH_MIN Num 8 TSH (mU/L), MIN (through M48)

1197 GLU_MAX Num 8 Glucose (mg/dL), MAX (through M48)

1198 CRE_MAX Num 8 Creatinine (mg/dL), MAX (through M48)

1199 GFR_MIN Num 8 Glomular Filtration Rate (eGFR), MIN (through M48)

1200 UPR_MAX Num 8 Urinary Protein, MAX (through M48)

1201 UHE_MAX Num 8 Urinary Heme, MAX (through M48)

1202 AFP_MAX Num 8 Local AFP (ng/ml), MAX (through M48)

1203 visit_num_last Char 4 $4. $3. Latest visit number

1204 wbc_last Num 8 X582F. 5.1 WBC latest visit

1205 neutrophils_last Num 8 X582F. 7.3 Neutrophils latest visit

1206 hematocrit_last Num 8 X582F. 5.1 Hematocrit latest visit


Num Variable Type Len Format Informat Label 1207 hemoglobin_last Num 8 X582F. 5.1 Hemoglobin latest visit

1208 platelets_last Num 8 X582F. 4. Platelets at latest visit

1209 bun_last Num 8 X582F. 4. BUN latest_visit

1210 creatinine_last Num 8 X582F. 5.1 Creatinine latest visit

1211 glucose_last Num 8 X582F. 4. Glucose latest visit

1212 trigly_last Num 8 X582F. 5. Trigly latest visit

1213 ast_last Num 8 X582F. 5. AST latest visit

1214 upper_ast_last Num 8 X582F. 4. Upper AST latest visit

1215 alt_last Num 8 X582F. 5. ALT latest visit

1216 upper_alt_last Num 8 X582F. 4. Upper ALT latest visit

1217 alkaline_last Num 8 X582F. 5. Alkaline latest visit

1218 upper_alki_last Num 8 X582F. 4. Upper Alki latest visit

1219 tot_bili_last Num 8 X582F. 6.1 Total Bili latest visit

1220 albumin_last Num 8 X582F. 6.1 Albumin latest visit

1221 globulin_last Num 8 X582F. 6.1 Globulin latest visit

1222 tot_protein_last Num 8 X582F. 6.1 Total Protein latest visit

1223 prothrombin_last Num 8 X582F. 5.1 Prothrombin latest visit

1224 tsh_last Num 8 X582F. 6.2 TSH latest visit

1225 protein_last Num 8 X412F. 3. Protein latest visit

1226 heme_last Num 8 X412F. 3. Heme latest visit

1227 afp_last Num 8 X582F. 8.2 AFP latest visit

1228 afp_norm_last Num 8 X582F. 8.2 AFP norm latest visit

1229 afp_bbi_last Num 8 AFP result from BBI/SeraCare latest visit

1230 days_rnd_last Num 8 days from Rand to latest Blood draw

1231 alt_ratio_last Num 8 ALT ratio latest visit

1232 ast_ratio_last Num 8 AST ratio latest visit

1233 ast_alt_last Num 8 AST/ALT latest visit

1234 alkphos_ratio_last Num 8 Alk phos ratio latest visit

1235 alt_norm_last Num 8 ALT norm latest visit

1236 ast_norm_last Num 8 AST norm latest visit

1237 apri_last Num 8 AST/platelets latest visit

1238 aprinew_last Num 8 100 X ast/ULN/platelets latest visit

1239 gfr_last Num 8 Glomular Filtration Rate (eGFR) latest visit

1240 MELD_S01 Num 8 MELD, S01

1241 MELD_W00 Num 8 MELD, W00






Num Variable Type Len Format Informat Label 1246 MELD_R00 Num 8 MELD, R00

1247 MELD_M12 Num 8 MELD, M12
















1263 R00_DAYS Num 8 Date of R00 visit (BT/Rel/Express Only) - Days from enrollment

1264 TRANS_DAYS Num 8 Date of transplant M51 - Days from enrollment

1265 DAYS_S01 Num 8 Blood Draw Date, S01 - Days from enrollment

1266 DAYS_S02 Num 8 Blood Draw Date, S02 - Days from enrollment

1267 DAYS_W00 Num 8 Blood Draw Date, W00 - Days from enrollment














1281 DAYS_R00 Num 8 Blood Draw Date, R00 - Days from enrollment

1282 DAYS_M09 Num 8 Blood Draw Date, M09 - Days from enrollment




Num Variable Type Len Format Informat Label 1285 DAYS_M18 Num 8 Blood Draw Date, M18 - Days from enrollment





















1306 blood_last_DAYS Num 8 Blood Draw date latest visit - Days from enrollment

1307 AGE Num 8 Age(yrs) at enrollment



Data Set Name: nonlabfu.sas7bdat

Num Variable Type Len Format Informat Label 1 weightc_kgW04 Num 8 Weight (kg) at W04

2 hepatomegaly_W12 Num 8 X550F. 3. Hepatomegaly at W12

3 spleen_W12 Num 8 X550F. 3. Spleen palpable (Physical Exam) at W12

4 ascites_W12 Num 8 X550F. 3. Ascites (Physical Exam) at W12

5 jaundice_W12 Num 8 X511F. 3. Jaundice at W12

6 enceph_W12 Num 8 X550F. 3. Encephalopathy at W12

7 edema_W12 Num 8 X550F. 3. Edema at W12

8 weightc_kgW12 Num 8 Weight (kg) at W12








16 bp1_W36 Num 8 X582F. 4. Systolic BP at W36

17 bp2_W36 Num 8 X582F. 4. Diastolic BP at W36








25 map_W36 Num 8 MAP at W36

26 bp1_W48 Num 8 X582F. 4. Systolic BP at W48












Num Variable Type Len Format Informat Label 37 bp1_W72 Num 8 X582F. 4. Systolic BP at W72










47 hepatomegaly_M09 Num 8 X550F. 3. Hepatomegaly at M09

48 spleen_M09 Num 8 X550F. 3. Spleen palpable (Physical Exam) at M09

49 ascites_M09 Num 8 X550F. 3. Ascites (Physical Exam) at M09

50 jaundice_M09 Num 8 X511F. 3. Jaundice at M09

51 enceph_M09 Num 8 X550F. 3. Encephalopathy at M09

52 edema_M09 Num 8 X550F. 3. Edema at M09

53 weightc_kgM09 Num 8 Weight (kg) at M09

54 bp1_M12 Num 8 X582F. 4. Systolic BP at M12

55 bp2_M12 Num 8 X582F. 4. Diastolic BP at M12








63 map_M12 Num 8 MAP at M12














Num Variable Type Len Format Informat Label 76 edema_M18 Num 8 X550F. 3. Edema at M18









85 waist_cmM24 Num 8 X582F. 4. Waist Circumference (cm) at M24
































































148 waist_cmM48 Num 8 X582F. 4. Waist Circumference (cm) at M48







Num Variable Type Len Format Informat Label 154 jaundice_M48 Num 8 X511F. 3. Jaundice at M48








































Num Variable Type Len Format Informat Label 232 enceph_M96 Num 8 X550F. 3. Encephalopathy at M96
























256 TOTAL_SCORE_W12 Num 8 X401F. 3. CTP score (Total) at W12





261 TOTAL_SCORE_M09 Num 8 X401F. 3. CTP score (Total) at M09











Num Variable Type Len Format Informat Label 271 TOTAL_SCORE_M39 Num 8 X401F. 3. CTP score (Total) at M39














285 BMI_W04 Num 8 BMI at W04







292 BMI_M09 Num 8 BMI at M09



















Num Variable Type Len Format Informat Label 310 BMI_M78 Num 8 BMI at M78






316 whratio_M24 Num 8 Waist to Height Ratio at M24

317 whratio_M48 Num 8 Waist to Height Ratio at M48

318 BMIchange_W04 Num 8 BMI change from Baseline to W04







325 BMIchange_M09 Num 8 BMI change from Baseline to M09

























Num Variable Type Len Format Informat Label 349 BMI_age20 Num 8 BMI at Age 20

350 BMI_age40 Num 8 BMI at Age 40

351 highBMI2040 Num 8 Highest BMI (from age 20 and age 40)

352 BMI_least Num 8 BMI at lowest weight

353 BMI_most Num 8 BMI at highest weight

354 BMIch_least Num 8 BMI change from least to baseline

355 BMIch_most Num 8 BMI change from most to baseline

356 BMIch_age20 Num 8 BMI change from age 20 to baseline

357 BMIch_age40 Num 8 BMI change from age 40 to baseline



Data Set Name: pri_outcome.sas7bdat

Num Variable Type Len Format Informat Label 1 LIVER_REL Num 8 3. 3. Liver related death local review

2 dth_a08 Num 8 YESNOF. All deaths on or before 12/31/2008-central review

3 dth_life_year_08 Num 8 Yrs from rand deaths 12/31/08-central review

4 dlr_08 Num 8 DLR08F. Liver related death 12/31/2008-central review

5 PRI_OUTCOME_A Num 8 YESNOF. Primary Clinical Outcome EXT

6 DTH_A Num 8 YESNOF. Death EXT

7 HCC_A Num 8 YESNOF. HCC EXT

8 CTP_A Num 8 YESNOF. CPT outcome EXT

9 VH_A Num 8 YESNOF. Variceal hemorrhage EXT

10 ASC_A Num 8 YESNOF. Ascites EXT

11 BPER_A Num 8 YESNOF. Spont. bact. peritonitis EXT

12 ENCE_A Num 8 YESNOF. Encephalopathy EXT

13 TRANS_A Num 8 YESNOF. transplant EXT

14 UNOS2B_A Num 8 YESNOF. UNOS 2B outcome EXT

15 PHCC_A Num 8 YESNOF. Presumed HCC EXT

16 HCC_PHCC_A Num 8 YESNOF. HCC/PHCC EXT

17 PRI_OUTCOME Num 8 YESNOF. Primary Clinical Outcome M51

18 DTH Num 8 YESNOF. Death M51

19 HCC_PHCC Num 8 YESNOF. HCC or Presumed HCC M51

20 HCC_PHCC_YRS Num 8 HCC or PHCC yrs from rand M51

21 FIRST_OUT Num 8 OUTCOMEF. First Outcome M51

22 FIRST_OUT_A Num 8 OUTCOMEF. First Outcome EXT

23 OUTC_YEARA Num 8 Yrs from rand to 1st clin outcome M51

24 OUTC_YEARA_A Num 8 Yrs from rand to 1st clin outcome EXT

25 DTH_LIFE_YEARA Num 8 Yrs from rand to death M51

26 DTH_LIFE_YEARA_A Num 8 Yrs from rand to death EXT

27 DTH_XNLR Num 8 YESNOF. Death excl DNLR M51

28 DTH_XNLR_TRANS Num 8 YESNOF. Death excl DNLR and Trans M51

29 DTH_XNLR_TRANS_YEARA Num 8 Yrs from rand to dth (excl DNLR) or Trans M51

30 DTH_XNLR_A Num 8 YESNOF. Death excl DNLR EXT

31 DTH_XNLR_TRANS_A Num 8 YESNOF. Death excl DNLR and Trans EXT

32 DTH_XNLR_TRANS_YEARA_A Num 8 Yrs from rand dth (excl DNLR) or Trans EXT

33 PRI_OUTCOME2 Num 8 YESNOF. Pri clin outcome excl DNLR M51

34 PRI_OUTCOME2_A Num 8 YESNOF. Pri clin outcome excl DNLR EXT

35 PRI_OUT2_NOHCC Num 8 YESNOF. Pri clin outcome excl DNLR & HCC M51

36 PRI_OUT2_NOHCC_A Num 8 YESNOF. Pri clin outcome excl DNLR & HCC EXT


Num Variable Type Len Format Informat Label 37 TPI_M24 Num 8 YESNOF. Ishak fibrosis increase >=2 M24

38 TPI_M48 Num 8 YESNOF. Ishak fibrosis increase >=2 M48

39 TPI_YEAR Num 8 Time for life table of TPI

40 TPI Num 8 YESNOF. two piont increase in ishak fibrosis

41 CLIN_TPI Num 8 YESNOF. TPI or clinical outcome

42 CLIN_TPI_YEARA Num 8 Yrs for TPI or clin outcome

43 CLIN_TPI2 Num 8 YESNOF. TPI or clin outcome, excl DNLR

44 CLIN_TPI2_NOHCC Num 8 YESNOF. TPI or clin outcome, excl DNLR & HCC

45 CTP_yrs_a Num 8 Yrs from rand to CTP EXT

46 VH_yrs_a Num 8 Yrs from rand to VH EXT

47 ASC_yrs_a Num 8 Yrs from rand to ASC EXT

48 BPER_yrs_a Num 8 Yrs from rand to BPER EXT

49 ENCE_yrs_a Num 8 Yrs from rand to ENCE EXT

50 hcc_phcc_LIFE_YEARA_A Num 8 Yrs from rand to HCC/PHCC EXT

51 def_hcc_LIFE_YEARA_A Num 8 Yrs from rand to def HCC EXT

52 PHCC_yrs_a Num 8 Yrs from rand to PHCC EXT

53 TRANS_yrs_a Num 8 Yrs from rand to Transplant EXT

54 UNOS2B_yrs_a Num 8 Yrs from rand to UNOS2B EXT



Data Set Name: dibisceglie_2005_rand_final.sas7bdat

Num Variable Type Len Format Informat Label 1 NEWSTAT Num 8 Status (Lead/Resp/R_L/R_B/R_E)


3 BMI Num 8 Body Mass Index

4 LIFE_DRINKS Num 8 Total number of drinks lifetime

5 alt Num 8 ALT, U/L

6 tot_bilirubi Num 8 Total bilirubin, mg/dL

7 albumin Num 8 Albumin, g/dL

8 prothrombin Num 8 Prothrombin time,INR

9 logcount Num 8 Log HCV RNA (IU/mL)

10 ALT_RATIO Num 8 ALT ratio to ULN

11 geno1s Num 8 Genotype 1 No/Yes by any method

12 CIRRHOSIS Num 8 Cirrhosis on biopsy (Ishak 5-6)

13 DURINF Num 8 Duration of infection - MD

14 AGE_RAND Num 8 Age at Randomization

15 GENO_GRP2 Num 8 HCV genotype: 1,2,3,4&6

16 RACE4 Num 8 Race (White, Black, Hispanic, Other)

17 SITE_RAND Num 8 Site at time of rand.

18 RAND_GRP Num 8 Randomization group

19 LAST_F10_VN Num 8 Visit number (-1 to 1054)

20 NEW_M48 Num 8 Month of visit that will be M48

21 REAS_NO_BIOP_M24 Num 8 Reason do not have biopsy M24

22 REAS_NO_BIOP_M48 Num 8 Reason do not have biopsy M48

23 LASTPEG_VISITN Num 8 Visit peg reduced to 0

24 EARLYSTOP_PEG Num 8 Peg stopped before M45 (yes/no)

25 STOP_OUTCOME Num 8 Stopped peg because of an outcome

26 REAS_GRP Num 8 Reason for stopping Peg early

27 SPEC_LENGTH_S00 Num 8 5.1 5.1 Specimen length S00

28 FIBRO_ISHAK_S00 Num 8 3. 3. Ishak Fibrosis S00 biopsy

29 INFLA_ISHAK_S00 Num 8 Ishak inflammation S00

30 FRAG_S00 Num 8 Biopsy on list of fragmented

31 FIBRO_ISHAK_M24 Num 8 3. 3. Ishak Fibrosis M24 biopsy

32 INFLA_ISHAK_M24 Num 8 Ishak inflammation M24

33 FIBRO_ISHAK_M48 Num 8 3. 3. Ishak Fibrosis M48 biopsy

34 INFLA_ISHAK_M48 Num 8 Ishak inflammation M48

35 BASEVR Num 8 HCV at base:Null L-I,Other L-I,Bt/rel,Express

36 WITHDR Num 8 Patient withrawn or missed 3+


Num Variable Type Len Format Informat Label 37 pri_outcome Num 8 Primary Clinical Outcome

38 BX_TIME_M48 Num 8 Timing of M48 Biopsy (Early,Okay,Late,VL)

39 DTH Num 8 Death

40 HCC Num 8 HCC

41 CTP Num 8 CTP >=7

42 VH Num 8 Variceal hemorrhage

43 ASC Num 8 Ascites

44 BPER Num 8 Spont. bact. peritonitis

45 ENCE Num 8 Encephalopathy

46 TRANS Num 8 transplant

47 UNOS2B Num 8 UNOS 2B outcome

48 PHCC Num 8 Presumed HCC

49 TRANS_DAYS Num 8 Transplant - Days from enrollment

50 FIRST_OUT Num 8 First Outcome (Death,HCC,CTP,VH,ASC,BPER,ENCE)

51 OUT_SUM Char 9 Outcome summary

52 OUTC_DAYS Num 8 Date for life table analyses - Days from enrollment

53 OUTC_YEAR Num 8 Years from randomization for life table

54 OUTC_YEARA Num 8 Years from randomization for life table, adj

55 TPI_YEAR Num 8 Time for life table of TPI

56 TPI Num 8 Two point increase in Ishak Fibrosis Score

57 CLIN_TPI Num 8 TPI or clinical outcome

58 CLIN_TPI_YEARA Num 8 Years for TPI or clinical outcome

59 FIBRO_ISHAK_D24 Num 8 Ishak Fibrosis M24 - S00

60 INFLA_ISHAK_D24 Num 8 Ishak inflammation M24 - S00

61 FIBRO_ISHAK_D48 Num 8 Ishak Fibrosis M48 - S00

62 INFLA_ISHAK_D48 Num 8 Ishak inflammation M48 - S00

63 ESOPH_VAR Num 8 F023: Esophogeal varices (0/1)

64 HAI_S00 Num 8 HAI_S00

65 HAI_M24 Num 8 HAI_M24

66 HAI_M48 Num 8 HAI_M48

67 ALT_S01 Num 8 ALT at 1st screening

68 ALT_S02 Num 8 ALT at 2nd screening

69 ALT_W00 Num 8 ALT at week 0





74 ALT_R00 Num 8 ALT at randomization

75 ALT_M09 Num 8 ALT at month 9


Num Variable Type Len Format Informat Label 76 ALT_M12 Num 8 ALT at month 12














90 STOP_AE Num 8 Stopped peg - adverse event

91 STOP_ANEMIA Num 8 Stopped peg - anemia

92 STOP_DEPR Num 8 Stopped peg - depression

93 STOP_NEUTRO Num 8 Stopped peg - neutropenia

94 STOP_REFUSED Num 8 Stopped peg - refused

95 STOP_THROMBO Num 8 Stopped peg - thrombocytopenia

96 PEG_START Char 3 Control pt, Month started peg

97 PEG_END Char 3 Control pt, month stopped peg

98 RIB_START Char 3 Control pt, month started rib

99 RIB_END Char 3 Control pt, month stopped rib

100 RNALOGA_S00 Num 8 Log HCV RNA at S00

101 RNALOGA_W00 Num 8 Log HCV RNA at W00

102 RNALOGA_W12 Num 8 Log HCV RNA at week 12



105 RNALOGA_R00 Num 8 Log HCV RNA at R00




109 RNALOGA_M12 Num 8 Log HCV RNA at month 12







Num Variable Type Len Format Informat Label 115 RNALOGA_M48 Num 8 Log HCV RNA at month 48


117 status09 Num 8 Peg status at month 9









126 GENO1TYPE Char 8 Genotype 1A or 1B

127 DAYS_IFN_BX2 Num 8 Days from last interferon to biopsy - form 50

128 DAYS_IFN_RAND2 Num 8 Days from last interferon to rand - form 50

129 ALT_NORM Num 8 Normal ALT at W00

130 TRT Num 8 Treatment Group (0/1)

131 HAI_D24 Num 8 HAI M24 - S00

132 HAI_D48 Num 8 HAI M48 - S00

133 ALT_S01_RATIO Num 8 ALT/ULN at 1st screening

134 ALT_S02_RATIO Num 8 ALT/ULT at 2nd screening

135 ALT_W00_RATIO Num 8 ALT/ULT at week 0





140 ALT_R00_RATIO Num 8 ALT/ULT at randomization

141 ALT_M09_RATIO Num 8 ALT/ULT at month 9














Num Variable Type Len Format Informat Label 154 ALT_M48_RATIO Num 8 ALT/ULT at month 48


156 LAST_DAYS Num 8 Days from randomization to last visit

157 FIRST_PRI Num 8 First outcome (clinical or biopsy)

158 PEG_STOP_EARLY Num 8 Stopped Peg early - not AE

159 PEG_STOP_TIME Num 8 Time stopped peg (<M09, M09-M23, M24-M44, M45+)

160 STOP_PENIA Num 8 Stopped Peg - cytopenia


162 RAND_DAYS Num 8 Randimazation - Days from enrollment

163 COURSE_DAYS Num 8 last interferon - Days from enrollment

164 LAST_IFN_DAYS Num 8 last interferon, Form 1 - Days from enrollment

165 LAST_F10_DAYS Num 8 Last Form 10 - Days from enrollment

166 FM25_LAST_DAYS Num 8 Form 25 - Days from enrollment

167 FM63_PRI_DAYS Num 8 First outcome - Days from enrollment

168 RAND_VIS_DAYS Num 8 R00 Visit - Days from enrollment

169 BIOPSY_DAYS_S00 Num 8 S00 Biopsy - Days from enrollment

170 DTH_DAYS Num 8 Death - Days from enrollment

171 HCC_DAYS Num 8 HCC - Days from enrollment

172 CTP_DAYS Num 8 CTP Outcome - Days from enrollment

173 VH_DAYS Num 8 Variceal hemorage - Days from enrollment

174 ASC_DAYS Num 8 Ascites - Days from enrollment

175 BPER_DAYS Num 8 Spont. bact. peritonitis - Days from enrollment

176 ENCE_DAYS Num 8 Encephalopathy - Days from enrollment

177 UNOS2B_DAYS Num 8 UNOS-2B - Days from enrollment

178 PHCC_DAYS Num 8 Presumed HCC - Days from enrollment

179 LAST_VIS_DAYS Num 8 Last Visit - Days from enrollment

180 ENDOSC_DAYS Num 8 Endoscopy - Days from enrollment

181 LAST_IFN_DAYS2 Num 8 last interferon, max of forms 1, 50 - Days from enrollment


Data Set Name: dienstag_2011_chc.sas7bdat

Num Variable Type Len Format Informat Label 1 FEMALE Num 8 Gender: 1=female and 0=male

2 BMI Num 8 Body Mass Index at baseline

3 platelets Num 8 Baseline platelets x1000/mm3

4 creatinine Num 8 Creatinine (mg/dL), Baseline

5 tot_bilirubi Num 8 Total Bilirubin (mg/dL), Baseline

6 albumin Num 8 Albumin (g/dL), Baseline

7 prothrombin Num 8 Prothrombin Time (INR), Baseline

8 CIRRHOSIS Num 8 Cirrhosis/Fibrosis (Ishak 5-6) at baseline (1=Cirrhosis, 0=Fibrosis)

9 MELD Num 8 MELD, Baseline

10 RAND_GRP Num 8 Randomization group, trt/control (1=trt, 2=control)

11 FIBRO_ISHAK_M24 Num 8 3. 3. Fibrosis-ishak score M24

12 FIBRO_ISHAK_M48 Num 8 3. 3. Fibrosis-ishak score M48

13 PRI_OUTCOME_A Num 8 First clinical outcome (1=Yes; 0=No) including (dth, hcc, ctp, vh, asc, sbp, ence)

14 DTH_A Num 8 All deaths (1=Yes; 0=No)

15 CTP_A Num 8 CTP >= 7 (1=Yes; 0=No)

16 VH_A Num 8 VH (1=Yes; 0=No)

17 ASC_A Num 8 Ascites (1=Yes; 0=No)

18 BPER_A Num 8 Spont. bact. Peritonitis (1=Yes; 0=No)

19 ENCE_A Num 8 Encephalopathy (1=Yes; 0=No)

20 TRANS_A Num 8 Transplants (1=Yes; 0=No)

21 HCC_PHCC_A Num 8 HCC/PHCC - extended (1=Yes; 0=No)

22 FIRST_OUT_A Num 8 OUTSSS. First outcome indicator (1 = Death, 2 = HCC, 3=CTP, 4=VH, 5=ASC, 6=BPER, 7=ENCE)

23 OUTC_YEARA_A Num 8 Years from randomization for pri_outcome_a and pri_outcome2_a

24 DTH_LIFE_YEARA_A Num 8 Years from randomization for mortality(dth_a)

25 DTH_XNLR_TRANS_YEARA_A Num 8 Time variable (from the randomization) to deaths/transplants (death_trans)

26 PRI_OUTCOME2_A Num 8 First clinical outcome (1=Yes; 0=No. Exclude death that is not related to liver), including liver dth, hcc, ctp, vh, asc, sbp, ence

27 hcc_phcc_LIFE_YEARA_A Num 8 Yrs from rand for HCC/PHCC - extended (hcc_phcc_a)

28 CTP_LIFE_YEAR_A Num 8 Years from Randomization for CTP (ctp_a)

29 VH_LIFE_YEAR_A Num 8 Years from Randomization for VH (vh_a)

30 ASC_LIFE_YEAR_A Num 8 Time variable (from the randomization) for asc_a

31 ENCE_LIFE_YEAR_A Num 8 Years from Randomization for ENCE (ence_a)



Num Variable Type Len Format Informat Label 33 PLT_M12 Num 8 Platelets, M12








































Num Variable Type Len Format Informat Label 72 ALB_M18 Num 8 Albumin (g/dL) M18


































106 PLT_M60 Num 8 4. 4. Platelet counts, M60

107 CRE_M60 Num 8 5.1 5.1 Creatinine (mg/dL), M60

108 BIL_M60 Num 8 6.1 6.1 Total Bilirubin (mg/dL), M60

109 ALB_M60 Num 8 6.1 6.1 Albumin (g/dL), M60

110 INR_M60 Num 8 5.1 5.1 Prothrombin Time (INR), M60


Num Variable Type Len Format Informat Label 111 MELD_M60 Num 8 MELD, M60








































Num Variable Type Len Format Informat Label 150 BIL_M102 Num 8 6.1 6.1 Total Bilirubin (mg/dL), M102










160 TRT Num 8 treatment group (1:trt, 0:control)

161 liverdeath Num 8 Liver deaths (1=Yes; 0=No)

162 liverdeath_trans Num 8 Liver deaths or transplants (1=Yes; 0=No)

163 liverdeath_trans_year Num 8 Yrs from randomization for Liver deaths or transplants (liverdeath_trans)

164 alldeath_trans Num 8 All deaths or transplants (1=Yes; 0=No)

165 age50 Num 8 Age group: 0: < 50 and 1: >=50

166 pri_outcome_every Num 8 First clinical outcome (1=Yes; 0=No) including (dth, hcc/phcc, ctp, vh, asc, sbp, ence, trans)

167 outc_yeara_every Num 8 Yrs from rand for first out (dth, hcc/phcc, ctp, vh, asc, sbp, ence, trans) (pri_outcome_every)

168 decomp_outcome Num 8 First decompensation outcome (including vh, asc, sbp and ence. 1=Yes; 0=No. )

169 decomp_yrs Num 8 Yrs from randomization for first outcome (of vh, asc, sbp, ence) (decomp_outcome)

170 hpdecomp_outcome Num 8 First hcc/decompensation outcome (1=Yes; 0=No) including (hcc/phcc, vh, asc, sbp, ence)

171 hpdecomp_yrs Num 8 Yrs from randomization for first outcome (of hcc, phcc, vh, asc, sbp, ence) (hpdecomp_outcome)

172 ctp_dth_yrs Num 8 Yrs from CTP to Deaths (dth_a)

173 ctp_hphcc_yrs Num 8 Yrs from CTP to HCC/PHCC (hcc_phcc_a)

174 ctp_vh_yrs Num 8 Yrs from CTP to VH (vh_a)

175 ctp_asc_yrs Num 8 Yrs from CTP to ASC (asc_a)

176 ctp_ence_yrs Num 8 Yrs from CTP to ENCE (ence_a)

177 ctp_ldthtrans_yrs Num 8 Yrs from CTP to Liver deaths/transplants (liverdeath_trans)

178 ctp_decomp_yrs Num 8 Yrs from CTP to decompensation (decomp_outcome)

179 ctp_hpdecomp_yrs Num 8 Yrs from CTP to HCC/PHCC or decompensation (hpdecomp_outcome)

180 ctp_alldthtrans_yrs Num 8 Yrs from CTP to All deaths/transplants (death_trans)

181 out_after_ctp_yrs Num 8 Time variable from the date of CTP to all clinical outcome (dth, hcc/phcc, ctp, vh, asc, sbp, ence, trans)


Num Variable Type Len Format Informat Label 182 decomp_dth_yrs Num 8 Yrs from Decompensation to Deaths (dth_a)

183 decomp_ldthtrans_yrs Num 8 Yrs from Decompensation to Liver deaths/transplants (liverdeath_trans)

184 decomp_alldthtrans_yrs Num 8 Yrs from Decompensation to All deaths/transplants (death_trans)

185 pltcate_a Num 8 Baseline platelets (1:<100, 2:100-<150, 3:150-<200, 4:200+)

186 FIRST_out_every Num 8 OUTSSSB. First outcome indicator (1 = Death, 2 = HCC, 3=CTP, 4=VH, 5=ASC, 6=BPER, 7=ENCE, 8=PHCC, 9=TRANS)

187 FIBRO_ISHAK Num 8 3. 3. Fibrosis-ishak score Baseline

188 SPLENECTOMY Num 8 Patient had splenectomy,1=Yes, missing=No

189 CIRR_YEAR Num 8 Time variable (from the randomization) for life table of CIRRM24M48

190 CIRRM24M48 Num 8 Cirrhosis at M24 or M48 (1=Yes; 0=No)

191 month_creat3 Num 8 Time variable (from the randomization) for out_creat3

192 month_bill3 Num 8 Time variable (from the randomization) for out_bill3

193 month_ptinr3 Num 8 Time variable (from the randomization) for out_ptinr3

194 month_albu3 Num 8 Time variable (from the randomization) for out_albu3

195 month_meld3 Num 8 Time variable (from the randomization) for out_meld3

196 month_plt3 Num 8 Time variable (from the randomization) for out_plt3

197 out_creat3 Num 8 First abnormal Creatinine (>=1.2 or not. 1=Yes; 0=No)

198 out_bill3 Num 8 First abnormal Bilirubin (>=2.0 or not. 1=Yes; 0=No)

199 out_ptinr3 Num 8 First abnormal PT/INR (>=1.7 or not. 1=Yes; 0=No)

200 out_albu3 Num 8 First abnormal Albumin (<=3.5 or not. 1=Yes; 0=No)

201 out_meld3 Num 8 First abnormal Meld (>=15 or not. 1=Yes; 0=No)

202 out_plt3 Num 8 First abnormal Platelets (<100K or not. 1=Yes; 0=No)

203 alt Num 8 Baseline ALT, U/L

204 logcount Num 8 Baseline Log HCV RNA (IU/mL)

205 DURINF Num 8 Duration of infection - MD

206 BMI_30 Num 8 Baseline BMI (0: bmi < 30 1: bmi >= 30)

207 ALT_90 Num 8 Baseline ALT (0: alt < 90 1: alt >= 90)

208 RNA_6_5 Num 8 Baseline Log(HCV RNA) (0: log(HCV RNA) < 6.5 1: log(HCV RNA) >= 6.5)


210 outc_daysa_every Num 8 Days from enrollment to the date for first outcome (dth, hcc/phcc, ctp, vh, asc, sbp, ence, trans) (pri_outcome_every)

211 rand_days Num 8 Days from enrollment to randomization


Data Set Name: lok_2005_hepatology.sas7bdat

Num Variable Type Len Format Informat Label 1 AGE Num 8 Age


3 HISP Num 8 Hispanic

4 WHITE Num 8 White

5 BLACK Num 8 Black race

6 OTHERS Num 8 Others

7 SER_FERR Num 8 6. 6. Serum ferritin (ng/mL)

8 iron_sat Num 8 Iron saturation

9 YR_INF_MD Num 8 5. 5. F06D4/C3. MD est earliest year infected

10 HEPATO Num 8 3. 3. Hepatomegaly

11 spleen Num 8 Spleen palpable


13 SPLENO Num 8 3. 3. Evidence of splenomegaly

14 GENO1 Num 8 Genotype 1 No/Yes

15 LOGCOUNT Num 8 HCV RNA log IU/ml

16 AFP_RESULT Num 8 8.2 8.2 AFP, ng/mL

17 FIBRO_ISHAK Num 8 3. 3. Fibrosis-ishak score

18 wbc Num 8 WBC x1000/mm3

19 neutrophils Num 8 Neutrophils x1000/mm3

20 hemoglobin Num 8 Hemoglobin, g/dL

21 platelets Num 8 Platelets x1000/mm3

22 ast Num 8 AST, U/L



25 albumin Num 8 Albumin, g/dL if


27 ALT_RATIO Num 8 ALT ratio to ULN

28 AST_RATIO Num 8 AST ratio to ULN

29 AST_ALT Num 8 AST/ALT

30 ALKPHOS_RATIO Num 8 Alk phos ratio ULN

31 CIRRHOSIS Num 8 Cirrhosis on biopsy (Ishak 5-6)

32 VISIT_NUM Char 3 $3. $3. Visit

33 SPEC_LENGTH Num 8 5.1 5.1 Biopsy length

34 fragmented Num 8 Fragmented biopsy

35 LIFE_DRINKS Num 8 TOT DRINK - LIFETIME

36 YEARS_DRANK2 Num 8 Years drank: sum with 0


Num Variable Type Len Format Informat Label 37 AVE_GRAMS_P_D Num 8 AV GMS OF ALCOHOL/DAY

38 training Num 8 Training or valid data set

39 ESOPH_VAR Num 8 F023: Esophogeal varices (0/1)

40 ASTALT Num 8 AST/ALT > 1

41 ALC_CONS_KG Num 8 Lifetime alcohol consumption (kg)

42 ISHAK56 Num 8 Ishak fibrosis score 5 or 6

43 length Num 8 Biopsy length(<1.5,1.5 - 2.5,> 2.5)

44 DURINF_MD Num 8 Duration of infection (MD opinion)

45 aprinew Num 8 100 X ast/ULN/platelets



Data Set Name: lok_2011_hcc_incidence.sas7bdat

Num Variable Type Len Format Informat Label 1 RAND_GRP Num 8 Randomization group (1=treatment, 2=control)

2 NEWSTAT Num 8 Status (1=lead-in only, 2=Responder, 3=rand lead-in, 4=rand BT/Rel, 5= rand express)

3 AGE Num 8 Age

4 FEMALE Num 8 Female (1=Yes, 0=No)

5 HISP Num 8 Hispanic (1=Yes, 0=No)

6 WHITE Num 8 White-non-hispanic (1=Yes, 0=No)

7 BLACK Num 8 Black or black + hisp (1=Yes, 0=No)

8 OTHERS Num 8 Others (1=Yes, 0=No)



11 PACKYEARS Num 8 F142 Packyears of cigarettes

12 neutrophils Num 8 Neutrophils x1000/mm3

13 platelets Num 8 Platelets x1000/mm3

14 ast Num 8 AST, U/L


16 alkaline Num 8 Alkaline phosphatase, U/L


18 albumin Num 8 Albumin, g/dL


20 logcount Num 8 Log HCV RNA (IU/mL)

21 ever_smoke Num 8 Ever smoked

22 geno1s Num 8 Genotype 1 No/Yes by any method (1=Yes, 0=No)

23 CIRRHOSIS Num 8 Cirrhosis on biopsy (Ishak 5-6) (1=Yes, 0=No)

24 highsugar Num 8 Glucose >= 126/diabetes (1=Yes, 0=No)

25 RACE4 Num 8 RACE4F. Race (White/Others, Black, Hispanic)

26 DTH_A Num 8 YESNOF. Death

27 HCC_A Num 8 YESNOF. HCC

28 TRANS_A Num 8 YESNOF. Transplant

29 PHCC_A Num 8 YESNOF. Presumed HCC

30 HCC_PHCC_A Num 8 YESNOF. HCC or PHCC

31 HCC_PHCC Num 8 YESNOF. HCC or Presumed HCC M51

32 FIRST_OUT_A Num 8 OUTCOMEF. First outcome (DTH,HCC,CTP,VH,ASC,BP,ENC)

33 DTH_LIFE_YEARA_A Num 8 Yrs from rand mortality adj EXT

34 hcc_phcc_LIFE_YEARA_A Num 8 Yrs from rand for HCC/PHCC EXT

35 HCC_LIFE_YEARA_A Num 8 Yrs from rand for def HCC EXT

36 PHCC_yrs_a Num 8 Yrs from rand for PHCC-ext


Num Variable Type Len Format Informat Label 37 TRANS_yrs_a Num 8 Yrs from rand for Transplant-ext

38 HCC Num 8 HCC M51 (1=Yes, 0=No)

39 PHCC Num 8 Presumed HCC M51 (1=Yes, 0=No)

40 OUT_SUM_A Char 10 Summary of outcomes

41 HCC_yrs_a Num 8 Years from rand fo HCC-ext

42 HCC_CAT Num 8 HCC_CATF. HCC category 1=HCC 2=PHCC

43 DCP_BL Num 8 DCP Base (W00 Lead-in, R00 Express)

44 CTP_BL Num 8 3. 3. CTP score W00/R00 Form 15

45 AFP_BL2 Num 8 AFP Local (W00/R00/S00)

46 ESOPH_VAR_M06 Num 8 Esophageal varices at M06 (1=Yes, 0=No)

47 ESOPH_VAR_M48 Num 8 Esophageal varices at M48 (1=Yes, 0=No)

48 ISHAK_XTR_VISIT Char 4 $3. $4. Visit number of extra biopsy

49 FIBRO_ISHAK_XTR Num 8 X582F. 3. Ishak fibrosis score extra biopsy

50 TUMOR_TYPE Num 8 TUMOR_TYPEF. 3. Tumor type (Form 56)

51 ED_GRADE Num 8 3. 3. Edmondson grade (1-4) (Form 56)

52 HISTOLOGY Num 8 X550F. 3. HCC diagnosis based on histology (Form 66)

53 AFP_1000 Num 8 X550F. 3. HCC diagnosis based on AFP > 1000, not hist (Form 66)

54 METH_DIAG Num 8 X480F. 3. HCC method of diagnosis (Form 66)

55 DIAG_HCC Num 8 3. 3. Patient diagnosed with HCC before transplant (Form 67, 1=Yes, 2=No)

56 PATH_HCC Num 8 3. 3. Transplant liver pathology show hcc (Form 67, 1=Yes, 2=No)

57 CNO_T_IMAGE Num 8 X536F. 3. F969: B1a. Type of imaging

58 CSUSP_IMAGE Num 8 X536F. 3. F969: B2a. Type of imaging

59 C_SNODULES Num 8 X420F. 3. F969: B2b. Number of tumor nodules in the liver

60 C_SUSP_SIZE Num 8 X401F. 5.1 F969: B2c. Size of largest nodules

61 C_SLOCATION Num 8 X522F. 3. F969: B2d. Nodule location

62 C_SUSP_INV Num 8 X564F. 3. F969: B2e. Portal vein invasion

63 C_SUS_SPREAD Num 8 X564F. 3. F969: B2f. Extrahepatic spread

64 C_HCC_IMAGE Num 8 X537F. 3. F969: B3a. Type of imaging

65 C_HCC_NODULE Num 8 X420F. 3. F969: B3b. Number of tumor nodules in the liver

66 C_HCC_SIZE Num 8 X401F. 5.1 F969: B3c. Size of largest nodules

67 C_HCC_LOCATN Num 8 X522F. 3. F969: B3d. Nodule location

68 C_HCC_INV Num 8 X564F. 3. F969: B3e. Portal vein invasion

69 C_HCC_SPREAD Num 8 X564F. 3. F969: B3f. Extrahepatic spread

70 C_HCC_TX Num 8 X550F. 3. F969: C1. Received any treatment for HCC

71 C_OLT Num 8 X550F. 3. F969: D1. Undergo liver transplant

72 C_OLT_ISHAK Num 8 X550F. 3. F969: D1a. Explant Ishak Fibrosis Score


Num Variable Type Len Format Informat Label 73 C_OLTNODULE Num 8 X420F. 3. F969: D1b. Explant number of tumor nodules in the

liver

74 C_OLT_SIZE Num 8 X401F. 5.1 F969: D1c. Explant nodule size

75 C_T_FACTOR Char 3 $3. $3. F969: E2a. T-factor

76 C_N_FACTOR Char 2 $2. $2. F969: E2b. N-factor

77 C_M_FACTOR Char 2 $2. $2. F969: E2c. M-factor

78 NO_TUMOR_YRS Num 8 F969:B1. Last image no tumor nodule, years since rand

79 SUSP_NOD_YRS Num 8 F969: B2. First suspicious nodule, years since rand

80 MET_DEF_YRS Num 8 F969: B3. First met criteria for HCC, years since rand

81 HCC_TRT_YRS Num 8 F969: C2. HCC treatment first administered, years since rand

82 VIS_FIRST_YRS Num 8 F969: E1. Tumor nodule met criteria, years since rand

83 EARLY_HCC_CRIT Num 8 F969: First imaging met criteria early HCC (1=Yes, 0=No)

84 EARLY_HCC_SUSP Num 8 F969: Imaging when HCC met criteria early HCC (1=Yes, 0=No)

85 PEG_START Char 3 Month of visit after started non-study peg

86 PEG_END Char 3 Month of visit after stopped non-study peg

87 FIBRO_ISHAK_S00 Num 8 3. 3. Ishak fibrosis score S00

88 HAI_S00 Num 8 HAI S00

89 FRAG_S00 Num 8 Fragmented biopsy S00 (1=Yes, 0=No)

90 BIOP_Days_S00 Num 8 Days from randomization to S00 biopsy

91 FIBRO_ISHAK_M24 Num 8 3. 3. Ishak fibrosis score M24

92 HAI_M24 Num 8 HAI M24

93 FRAG_M24 Num 8 Fragmented biopsy M24 (1=Yes, 0=No)

94 BIOP_Days_M24 Num 8 Days from randomization to M24 biopsy

95 FIBRO_ISHAK_M48 Num 8 3. 3. Ishak fibrosis score M48

96 HAI_M48 Num 8 HAI M48

97 FRAG_M48 Num 8 Fragmented biopsy M48 (1=Yes, 0=No)

98 BIOP_Days_M48 Num 8 Days from randomization to M48 biopsy

99 TRT Num 8 Treatment Group (1=Yes, 0=No)

100 BT_REL Num 8 Randomized as Breakthrough or Express (1=Yes, 0=No)

101 EXPRESS Num 8 Randomized as Express (1=Yes, 0=No)

102 NEW_GENOTYPE Num 8 Genotype: Not 1, 1a, 1a/1b, 1b, 1 nosub

103 HCC_TYPE Num 8 0:None,1:PHCC only,2:Both,3:HCC only

104 HCC_PHCC_DAYS_A Num 8 Days from randomization to HCC/PHCC diagnosis

105 HCC_VISIT_DIF Num 8 Days from visit before to HCC/PHCC diagnosis

106 HCC_VISIT2 Num 8 Visit before or at diagnosis of HCC/PHCC - 9, 12, etc

107 LAST_VISIT_YRS_A Num 8 Years from randomization to last study visit, incl ext.


Num Variable Type Len Format Informat Label 108 VISIT_DAYS_PHCC Num 8 Days from PHCC to last visit

109 LIFE_FOL_DAYS_PHCC Num 8 Days from PHCC to last contact

110 TX_DAYS_DXPHCC Num 8 Days from PHCC to transplant

111 TX_DAYS_DXHCC Num 8 Days from HCC to transplant

112 HCC_PHCC_COMP Num 8 Competing Risk (0=none,1=HCC/PHCC,2=TX

113 RNALOGA_AVE_SW Num 8 Mean log HCV RNA (S00,W00/R00)

114 RNA_DEC_LEAD2 Num 8 RNA decrease S00/W00/R00 to W20 (<2,2-3,4+)

115 RNALOGA_AVE_M24 Num 8 Mean log HCV RNA (M12,M18,M24)

116 RNALOGA_M24S Num 8 Log HCV RNA S00/W00/R00 minus M24 av

117 RNA_DEC_M24 Num 8 RNA decrease S00/W00/R00 to M24 av(<2,2-3,4+)

118 BIOP_YRS_M24 Num 8 Years from rand to M24 biopsy

119 BIOP_YRS_M48 Num 8 Years from rand to M48 biopsy

120 CIRRHOSIS_M24 Num 8 Cirrhosis on biopsy (Ishak 5-6) at M24 (1=Yes, 0=No)

121 CIRRHOSIS_M48 Num 8 Cirrhosis on biopsy (Ishak 5-6) at M48 (1=Yes, 0=No)

122 HAI_IMP2_M24 Num 8 HAI decreased by >2 points S00 to M24 (1=Yes, 0=No)

123 HCC_PHCC_LIFE_WEEK Num 8 Week last contact/HCC (life)

124 LAST_F10_WEEK Num 8 Week of last visit (form 10)

125 M48_WEEK Num 8 Week of M48 visit (form 30)

126 M24_WEEKA Num 8 Week of M24 visit (or 21, 27, form 30)



129 LAST_F10_WEEK2 Num 8 Week of last visit (form 10), max 182

130 HCC_PHCC_LIFE_WEEK2 Num 8 Week of last visit or HCC/PHCC, max 182

131 M48_WEEK2 Num 8 Week number of M48 visit (max 182)

132 PEG_CONTROL Num 8 Control patient started PEG before HCC (1=Yes, 0=No)

133 PEG_LAST_WEEK Num 8 Last week of peg/ifn

134 PEG_LAST_WEEK2 Num 8 Last week of peg/ifn, max 182

135 PEG_UNTIL_M48 Num 8 Took peg/ifn until M48 (1=Yes, 0=No)

136 PEG_UNTIL_M24A Num 8 Took peg/ifn until M24(M21-M27) (1=Yes, 0=No)

137 PEG_STOP_AFT_LT12 Num 8 Peg/ifn stopped > 12 weeks bef (1=Yes, 0=No)

138 PEG_STOP_AFT_LT24 Num 8 Peg/ifn stopped > 24 weeks bef (1=Yes, 0=No)

139 PEG_PERC_LAST Num 8 Total dose Peg/ifn % 90 up to LT/W182

140 PEG_PERC_M48 Num 8 Total dose Peg/ifn % 90 up to M48




144 reasnobiop_m24 Num 8 MISSBIOF. Reason M24 biopsy not done (0=done, 1-6 reason not done, 10=Inadequate)


Num Variable Type Len Format Informat Label 145 reasnobiop_m48 Num 8 MISSBIOF. Reason M48 biopsy not done (0=done, 1-6 reason not

done, 10=Inadequate)



Data Set Name: rand_assign.sas7bdat

Num Variable Type Len Format Informat Label 1 RAND_RESULT Num 8 RANDRESF. 2. Randomization assignment

2 PATIENT_TYPE Num 8 PTYPERF. 2. Patient type



Data Set Name: ae.sas7bdat

Num Variable Type Len Label 1 BLO_LYM_A Num 8 Bloood & Lymphatic AE

2 CAR_CIR_A Num 8 Cardiovascular & Circulatory AE

3 DIG_SYS_A Num 8 Digestive System AE

4 END_MET_A Num 8 Endocrine & Metabolic AE

5 EYE_EAR_A Num 8 Eye & EAr AE

6 GEN_REP_A Num 8 GEnitourinary & Reproductive AE

7 HEP_BIL_A Num 8 Hepato-biliary AE

8 INF_ANY_A Num 8 Any Infection AE

9 INF_BAC_A Num 8 Bacterial Infection AE

10 INF_OTH_A Num 8 Other Infection AE

11 INJ_POI_A Num 8 Injury & Poisoning AE

12 MUS_SKE_A Num 8 Musculoskelital AE

13 NEOPLAS_A Num 8 Neoplasm AE

14 NEUROLO_A Num 8 Neurological AE

15 PSYCHIA_A Num 8 Psychiatric AE

16 RESPIRA_A Num 8 Respiratory AE

17 SIG_SYM_A Num 8 Signs & Symptoms AE

18 SKIN_A Num 8 Skin AE

19 OTHER_A Num 8 Other AE

20 FIRST_A Num 8 Week of first AE

21 LAST_A Num 8 Week of last AE

22 CAR_CIR_S Num 8 Cardiovascular & Circulatory SAE

23 DIG_SYS_S Num 8 Digestive System SAE

24 GEN_REP_S Num 8 Genitourinary & Reproductive SAE

25 HEP_BIL_S Num 8 Hepatobiliary SAE

26 INF_ANY_S Num 8 Any Infection SAE

27 INF_BAC_S Num 8 Bacterial Infection SAE

28 INF_OTH_S Num 8 Other infection SAAE

29 MUS_SKE_S Num 8 Musculoskelital SAE

30 NEOPLAS_S Num 8 Neoplasm SAE

31 PSYCHIA_S Num 8 Psychiatric SAE

32 SIG_SYM_S Num 8 Signs & Symproms SAE

33 OTHER_S Num 8 Other SAE

34 FIRST_S Num 8 Week of first SAE

35 LAST_S Num 8 Week of last SAE

36 n_a Char 7 Number of AE


Num Variable Type Len Label 37 N_S Char 3 Number of SAE



Data Set Name: form007_012_meds_new.sas7bdat

Num Variable Type Len Format Informat Label 1 MEDTYPE Char 12 $CHAR12. $11. Type of medication Rx/OTC/Herbal

2 MEDNAME Char 40 $40. $40. Medication name

3 MCODE Char 10 $10. $10. Medication code

4 START_VISIT Char 3 $3. $3. Medication start visit

5 STOP_VISIT Char 3 $3. $3. Medication stop visit


7 STOP_DAYS Num 8 Stop Date - days since enrollment

8 START_DAYS Num 8 Start Date - days since enrollment

9 MCODE2 Char 10 Corrected Medication Code

10 LAST_F10_VNUM Char 3 $3. $3. Form 10 - last visit number

11 last_f10_days Num 8 Form 10 - last date - days since enrollment



Data Set Name: form007_everherb.sas7bdat

Num Variable Type Len Format Informat Label 1 EVERHERBNAME Char 40 $40. $40. FO07: C2a. Herbal Medication name

2 EVERHERBCODE Char 10 $10. $10. FO07: C2b. Herbal medication code

3 EVERHERBYEAR Num 8 X401F. 3. FO07: C2c. Number of years used this herbal once a week

4 EVERHERBMON Num 8 X401F. 3. FO07: C2d. Number of months used this herbal medication once a week



Data Set Name: form010.sas7bdat

Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 3 $3. $3. FO10: A3. Visit Number

2 HOSP_OVER Num 8 X550F. 3. FO10: B1. Admitted to the hospital overnight

3 HOSP_SURG Num 8 X550F. 3. FO10: B2. Hospital visit requiring surgery?

4 HOSP_VISIT Num 8 X550F. 3. FO10: B3. Visit to healthcare professional or ER

5 HEALTH_CHANG Num 8 X550F. 3. FO10: B4. Changes in patient's health?

6 TAKE_MED Num 8 X550F. 3. FO10: D5. Is the patient supposed to be taking ribavirin now?

7 PEG_VERS_B Num 8 X559F. 3. Any doses of Peg alfa-2a not taken - Ver A/B

8 RIB_SKIPPED Num 8 X559F. 3. Any does of Ribavirin not taken - Ver A/B

9 DOSES Char 2 $2. FO10: D2. How many doses of Peg did patient not take

10 NUM_MISSED Char 2 $2. FO10; D5. Number of Ribavirin not taken?


12 VISIT_DAYS Num 8 FO10: B4. Visit Date - days since enrollment



Num Variable Type Len Format Informat Label 1 VISIT_NO Char 3 $3. $3. FO11: A3. Visit Number

2 WEIGHT_KG Num 8 X582F. 6.1 FO11: B1a. Weight(kg)

3 HEIGHT_CM Num 8 X582F. 4. FO11: B2a. Height (cm)

4 WAIST_CM Num 8 X582F. 4. FO11: B3a. Waist circumference in cm

5 BP1 Num 8 X582F. 4. FO11: B4a. Blood Pressure (systolic)

6 BP2 Num 8 X582F. 4. FO11: B4b. Blood pressure (diastolic)

7 PULSE Num 8 X582F. 4. FO11: B5. Pulse rate per minute

8 GEN_APP Num 8 X487F. 3. FO11: B6. General Appearance

9 HEAD Num 8 X487F. 3. FO11: B7. Head

10 EARS Num 8 X487F. 3. FO11: B8. Ears, nose and throat?

11 EYES Num 8 X487F. 3. FO11: B9. Eyes?

12 NECK Num 8 X487F. 3. FO11: B10. Neck?

13 LYMPH Num 8 X487F. 3. FO11: B11. Lymph Nodes?

14 SKIN Num 8 X487F. 3. FO11: B12. Skin?

15 LUNGS Num 8 X487F. 3. FO11: B13. Lungs?

16 HEART Num 8 X487F. 3. FO11: B14. Heart?

17 ABDOMEN Num 8 X487F. 3. FO11: B15. Abdomen?

18 MUSCULO Num 8 X487F. 3. FO11: B16. Musculoskeletal?

19 NEUROLOGIC Num 8 X487F. 3. FO11: B17. Neurologic?

20 BREASTS Num 8 X487F. 3. FO11: B18. Breasts?

21 RECTAL Num 8 X487F. 3. FO11: B19. Rectal?

22 PELVIC Num 8 X487F. 3. FO11: B20. Genitourinary/Pelvic?

23 HEPATO Num 8 X550F. 3. FO11: C1. Hepatomegaly

24 SPLENO Num 8 X550F. 3. FO11: C2. Spleen palpable?

25 ASCITES Num 8 X550F. 3. FO11: C3. Ascites?

26 ASCITES_SEV Num 8 X475F. 3. FO11: C3a. Ascites Severity?

27 JAUNDICE Num 8 X511F. 3. FO11: C4. Jaundice?

28 ENCEPH Num 8 X550F. 3. FO11: C5. Encephalopathy?

29 ENCEPH_GRADE Num 8 X582F. 3. FO11: C5a. Encephalopathy grade?

30 EDEMA Num 8 X550F. 3. FO11: C6. Edema?

31 FINDINGS Num 8 X550F. 3. FO11: D1. Are there any new findings?

32 HEPATO_SPAN Char 3 FO11: C1a. Span (Right midclavicular line)

33 EDEMA_SEV Char 2 FO11: C6a. Edema Severity?


35 EXAM_DAYS Num 8 FO11: A4. # days from enrollment to physical exam




2 SPECIMEN_SIZ Num 8 X582F. 3. FO14: B3. Size of specimen collected at this visit

3 PURPOSE Num 8 X498F. 3. FO14: B4b. Purpose of specimen

4 HOW_HANDLED Num 8 X523F. 3. FO14: B4c. How Collected/Handled

5 PURPOSE2 Num 8 X498F. 3. FO14: B5b. Purpose of specimen

6 HOW_HANDLED2 Num 8 X523F. 3. FO14: B5c. How Collected/Handled






12 LIVER_TIS_B Num 8 X550F. 3. FO14: B1. Was liver tissue collected at this visit?


14 BIOPSY_DAYS Num 8 FO14: B2. Biopsy collection - days since enrollment




2 SER_ALB Num 8 X426F. 3. FO15: B1. Points for serum albumin (g/dL) (Score 1-3)

3 SER_TOT Num 8 X425F. 3. FO15: B2. Serum total bilirubin (Score 1-3)

4 PRO_TIME Num 8 X423F. 3. FO15: B3. Prothrombin Time (Score 1-3)

5 ASCITES Num 8 X483F. 3. FO15: B4. Ascites score (1-3)

6 ENCEPH Num 8 X483F. 3. FO15: B5. Encephalopathy score (1-3)

7 TOTAL_SCORE Num 8 X401F. 3. FO15: B6. Total Score (5 - 15)


9 visit_days Num 8 FO15: A4. # days from enrollment to visit




2 HYPO_EVER Num 8 X550F. 3. FO16: B8a. Patient diagnosed with condition: Hypothyroidism

3 HYPO_ENR Num 8 X550F. 3. FO16: B8b. Was diagnosis present at: Hypothyroidism

4 HYPO_AFT Num 8 X550F. 3. FO16: B8c. Was diagnosis present after: Hypothyroidism

5 HYPO_CHNGE Num 8 X435F. 3. FO16: B8d. Was diagnosis better/worse: Hypothyroidism

6 PSYCH_EVER Num 8 X550F. 3. FO16: B23a. Patient diagnosed with condition: Neuropsychiatric

7 PSYCH_AT_ENR Num 8 X550F. 3. FO16: B23b. Was diagnosis present at: Neuropsychiatric

8 PSYCH_ENR Num 8 X550F. 3. FO16: B23c. Was diagnosis present after: Neuropsychiatric

9 PSYCH_CHNGE Num 8 X435F. 3. FO16: B23d. Was diagnosis better/worse: Neuropsychiatric


11 DIAB_EVER Num 8 X550F. FO16: B2a/B3a. Pt diagnosed with condition: Diabetes 1 or 2

12 DIAB_ENR Num 8 X550F. FO16: B2b/B3b. Was diagnosis present at: Diabetes 1 or 2

13 DIAB_AFT Num 8 X550F. FO16: B2c/B3c. Was diagnosis present after: Diabetes 1 or 2

14 DIAB_CHNGE Num 8 X435F. FO16: B2d/B3d. Was diagnosis better/worse: Diabetes 1 or 2

15 visit_days Num 8 FO16: A4. # days from enrollment




2 PRIM_REAS Num 8 ETTREATF. 3. FO19: B2. Primary reason for early termination? (RE-CODED)


4 LAST_DAYS Num 8 FO19: B1. Last dose - days since enrollment



Num Variable Type Len Format Informat Label 1 VISIT_DATE Num 8 MMDDYY10. DATETIME20. FO21: A4. Date form completed

2 ISH_SCO Num 8 X421F. 3. FO21: B1. Ishak fibrosis score

3 RAND_ELIG Num 8 X550F. 3. FO21: B7. Is patient eligible for randomization?

4 EVENTTYPE_ID Char 4 $4. $4. Visit


6 rand_days Num 8 # of days from enrollment date to randomization




2 ASC_EVID Num 8 X550F. 3. FO22: B3. Ascites evidence

3 LIVER_MASS Num 8 X550F. 3. FO22: B4. Evidence of a liver mass?

4 SPLENO Num 8 X550F. 3. FO22: B5. Splenomegaly?

5 OTH_FIN Num 8 X550F. 3. FO22: B6. Any other findings?

6 DEF_LIVER Num 8 X405F. 3. FO22: B4b. Is the liver mass

7 EVID_SPLENO Num 8 X557F. 3. FO22: B5. Was there evidence of splenomegaly (>13 cm)?

8 FU_LIVER Num 8 X550F. 3. FO22: B4e. Does liver mass require further follow-up at this visit?

9 PRIOR_REP Num 8 X550F. 3. FO22: B4c. Are there prior films or a report available?

10 TEST_TYPE Num 8 X535F. 3. FO22: B2. Test performed was

11 SPLEEN_SIZE Char 3 FO22: B5a. Greatest length of spleen in any dimension


13 max_diac Num 8 MAXDIAMF. FO22: B4a. Maximum diameter of liver mass? (Categorical)

14 ULTRA_DAYS Num 8 FO22: B1. Imaging test: # days since enrollment

15 FU_DAYS Num 8 FO22: B4i. Follow-up test: # days since enrollment



Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 3 $3. $3. FO23: A3. Visit number:

2 E_NORMAL Num 8 X550F. 3. FO23: B3. Was endoscopy normal

3 E_VARICES Num 8 X550F. 3. FO23: C1. Was there evidence of esophageal varices

4 E_GRADE Num 8 X527F. 3. FO23: C1a. Grade of esophageal varices

5 RED_SIGNS Num 8 X550F. 3. FO23: C1c. Were there red signs

6 GASTRIC_VAR Num 8 X550F. 3. FO23: C2. Evidence of gastric varices

7 L_GAS_VAR Num 8 X406F. 3. FO23: C2a. Size of largest gastric varix

8 PORT_HYP_GAS Num 8 X550F. 3. FO23: D1. Was there evidence of portal hypertensive gastropathy

9 MUCOSAL Num 8 X403F. 3. FO23: D1a. Mucosal mosaic pattern

10 RED_MARKS Num 8 X404F. 3. FO23: D1b. Red marks

11 ECTASIA Num 8 X511F. 3. FO23: D1c. Gastric antral vascular ectasia

12 OTH_FIND Num 8 X550F. 3. FO23: E1. Were there any other findings

13 IGV Num 8 X550F. FO23: C2c/d. Isoloated gastric varices

14 GOV Num 8 X550F. FO23: C2e/f. Gastroesophogeal varices

15 NUM_C Char 2 FO23: C1b. Number of columns


17 ENDOSC_DAYS Num 8 FO23: B1. Endscopy Date: # of days from enrollment date




2 PRI_REAS Num 8 X502F. 3. FO24: B1. Primary reason for missed visit





2 PRI_REAS Num 8 X501F. 3. FO25: B2. Primary reason


4 LAST_DAYS Num 8 FO25: B1. Patient last seen, days since enrollment



Num Variable Type Len Format Informat Label 1 INITDOSE Num 8 X417F. 3. FO26: B1. Initial dose of Peginferferon alfa-2a




Num Variable Type Len Format Informat Label 1 INITDOSE Num 8 X416F. 3. FO27: B1. Initial dose of ribavirin:




Num Variable Type Len Format Informat Label 1 PREVDOSE Num 8 X401F. 4. FO28: B1b. Previous dose

2 CURRDOSE Num 8 X401F. 4. FO28: B1c. Dose change to:

3 DOSEREAS Num 8 REASF. 3. FO28: B1d1. Reason dose change code:


5 DOSE_CHG_DAYS Num 8 FO28: B1a. Dose change, days since enrollment



Num Variable Type Len Format Informat Label 1 PREVDOSE Num 8 X401F. 5. FO29: B1b. Previous dose

2 CURRDOSE Num 8 X401F. 5. FO29: B1c. Dose change to:

3 DOSEREAS Num 8 RIBREASF. 3. FO29: B1d1. Reason dose change code:


5 DOSE_CHG_DAYS Num 8 FO29: B1a. Dose change, days since enrollment


Data Set Name: form030_34_35.sas7bdat


2 WBC Num 8 X582F. 5.1 WBC x1000/mm3

3 NEUTROPHILS Num 8 X582F. 7.3 Neutrophils x1000/mm3

4 HEMATOCRIT Num 8 X582F. 5.1 Hematocrit, %

5 HEMOGLOBIN Num 8 X582F. 5.1 Hemoglobin, g/dL

6 PLATELETS Num 8 X582F. 4. Platelets x1000/mm3

7 BUN Num 8 X582F. 4. BUN, mg/dL

8 CREATININE Num 8 X582F. 5.1 Creatinine, mg/dL

9 GLUCOSE Num 8 X582F. 4. Glucose, mg/dL

10 TRIGLYCERIDE Num 8 X582F. 5. Triglycerides,mg/dL

11 URIC_ACID Num 8 X582F. 5.1 Uric acid, mg/dL

12 AST Num 8 X582F. 5. AST, U/L

13 UPPER_AST Num 8 X582F. 4. FO30: E1a. Upper limit of normal

14 ALT Num 8 X582F. 5. ALT, U/L

15 UPPER_ALT Num 8 X582F. 4. FO30: E2a. Upper limit of normal

16 ALKALINE Num 8 X582F. 5. Alkaline phosphatase, U/L

17 UPPER_ALKALI Num 8 X582F. 4. FO30: E3a. Upper limit of normal

18 TOT_BILIRUBI Num 8 X582F. 6.1 Total bilirubin, mg/dL

19 ALBUMIN Num 8 X582F. 6.1 Albumin, g/dL

20 GLOBULIN Num 8 X582F. 6.1 Globulin, g/dL

21 TOT_PROTEIN Num 8 X582F. 6.1 Total protein, g/dL

22 PROTHROMBIN Num 8 X582F. 5.1 Prothrombin time,INR

23 TSH Num 8 X582F. 6.2 TSH mU/L

24 PROTEIN Num 8 X412F. 3. Urine Protein (0-4+)

25 HEME Num 8 X412F. 3. Urine Heme (0-4+)

26 PREGNANT Num 8 X506F. 3. Pregnancy test result

27 AFP Num 8 X582F. 8.2 AFP, ng/mL

28 AFP_NORM Num 8 X582F. 8.2 AFP ULN, ng/mL

29 BBI_AFP Num 8 AFP done at BBI

30 FAST_HOURS Num 8 Hours fasting to blood draw


32 AFP_BLOOD_DAYS Num 8 FO34: B1. AFP blood drawn - days since enrollment

33 BLOOD_DAYS Num 8 Form 30/35 Local Lab: blood drawn - days since enrollment


Data Set Name: form031_32_37.sas7bdat


2 QUANT_S00 Num 8 QUANTF. S00 Quantitative HCV RNA assay result

3 QUANT_W00 Num 8 QUANTF. W00 Quantitative HCV RNA assay result






9 QUANT_R00 Num 8 QUANTF. R00 Quantitative HCV RNA assay result


11 QUANT_W36X Num 8 QUANTF. W36 REPEAT Quantitative HCV RNA assay result








19 QUANT_M12 Num 8 QUANTF. M12 Quantitative HCV RNA assay result








27 QUAL_S00 Num 8 QUALF. S00 Qualitative HCV RNA assay result

28 QUAL_W00 Num 8 QUALF. W00 Qualitative HCV RNA assay result






34 QUAL_R00 Num 8 QUALF. R00 Qualitative HCV RNA assay result


36 QUAL_W36X Num 8 QUALF. W36 REPEAT Qualitative HCV RNA assay result


Num Variable Type Len Format Informat Label 37 QUAL_W42X Num 8 QUALF. W42 REPEAT Qualitative HCV RNA assay result







44 QUAL_M12 Num 8 QUALF. M12 Qualitative HCV RNA assay result








52 VALRNA_S00 Num 8 S00 Quantitative HCV RNA assay result

53 VALRNA_W00 Num 8 W00 Quantitative HCV RNA assay result






59 VALRNA_R00 Num 8 R00 Quantitative HCV RNA assay result


61 VALRNA_W36X Num 8 W36 REPEAT Quantitative HCV RNA assay result








69 VALRNA_M12 Num 8 M12 Quantitative HCV RNA assay result








Num Variable Type Len Format Informat Label 76 VALRNA_M54 Num 8 M54 Quantitative HCV RNA assay result

77 HCVRNAP_S00 Num 8 HCVSTATF. S00 HCV RNA Status

78 HCVRNAP_W00 Num 8 HCVSTATF. W00 HCV RNA Status






84 HCVRNAP_R00 Num 8 HCVSTATF. R00 HCV RNA Status


86 HCVRNAP_W36X Num 8 HCVSTATF. W36 REPEAT HCV RNA Status








94 HCVRNAP_M12 Num 8 HCVSTATF. M12 HCV RNA Status









103 BLOOD_S00 Num 8 S00 Blood Draw - days from enrollment

104 BLOOD_W00 Num 8 S00 Blood Draw - days from enrollment

105 BLOOD_W08 Num 8 W08 Blood Draw - days from enrollment





110 BLOOD_R00 Num 8 R00 Blood Draw - days from enrollment


112 BLOOD_W36X Num 8 W36 REPEAT Blood Draw - days from enrollment




Num Variable Type Len Format Informat Label 115 BLOOD_W48X Num 8 W48 REPEAT Blood Draw - days from enrollment





120 BLOOD_M12 Num 8 M12 Blood Draw - days from enrollment










Num Variable Type Len Format Informat Label 1 HCV_GENOTYPE Num 8 X550F. 3. FO33: B2. Possible to determine HCV genotype

2 ADD_TEST Num 8 X550F. 3. FO33: C1. Was additional testing performed

3 SUBTYPE_POS Num 8 X547F. 3. FO33: B4. Was it possible to determine HCV subtype from this specimen

4 VISIT_NUM Char 3 $3. $3. FO33: A2. Visit number:

5 GENOTYPE Char 8 Genotype


7 assay_days Num 8 FO33: B1. # of days from Enrollment



Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 3 $3. $3. FO36: A3. Visit number:

2 AFP_RESULT Num 8 X582F. 8.2 FO36: B2. AFP result

3 AFP_NORM Num 8 X582F. 8.2 FO36: B2a. AFP: upper limit of normal


5 BLOOD_DAYS Num 8 FO36: B1. Blood drawn - days since enrollment




2 WBC Num 8 X582F. 5.1 FO38: B1. WBC

3 NEUTROPHILS Num 8 X582F. 7.3 FO38: B2. Neutrophils

4 HEMATOCRIT Num 8 X582F. 5.1 FO38: B3. Hematocrit

5 HEMOGLOBIN Num 8 X582F. 5.1 FO38: B4. Hemoglobin

6 PLATELETS Num 8 X582F. 4. FO38: B5. Platelets

7 BUN Num 8 X582F. 4. FO38: C1. BUN

8 CREATININE Num 8 X582F. 5.1 FO38: C2. Creatinine

9 GLUCOSE Num 8 X582F. 4. FO38: C3. Glucose

10 TRIGLYCERIDE Num 8 X582F. 5. FO38: C4. Triglycerides

11 AST Num 8 X582F. 5. FO38: D1. AST (SGOT)

12 UPPER_AST Num 8 X582F. 4. FO38: D1a. Upper limit of normal

13 ALT Num 8 X582F. 5. FO38: D2. ALT (SGPT)

14 UPPER_ALT Num 8 X582F. 4. FO38: D2a. Upper limit of normal

15 ALKALINE Num 8 X582F. 5. FO38: D3. Alkaline phosphatase

16 UPPER_ALKALI Num 8 X582F. 4. FO38: D3a. Upper limit of normal

17 TOT_BILIRUBI Num 8 X582F. 6.1 FO38: D4. Total bilirubin

18 ALBUMIN Num 8 X582F. 6.1 FO38: D5. Albumin

19 GLOBULIN Num 8 X582F. 6.1 FO38: D6. Globulin

20 TOT_PROTEIN Num 8 X582F. 6.1 FO38: D6.1. Total Protein

21 PROTHROMBIN Num 8 X582F. 5.1 FO38: E1. Prothrombin Time


23 WBC_DAYS Num 8 FO38: B1a. Days from WBC blood draw to enrollment

24 NEUTRO_DAYS Num 8 FO38: B2a. Days from neutrophils blood draw to enrollment

25 HCRIT_DAYS Num 8 FO38: B3a. Days from hematocrit blood draw to enrollment

26 HGLOBIN_DAYS Num 8 FO38: B4a. Days from hemoglobin blood draw to enrollment

27 PLAT_DAYS Num 8 FO38: B5a. Days from platelets blood draw to enrollment

28 BUN_DAYS Num 8 FO38: C1a. Days from BUN blood draw to enrollment

29 CREAT_DAYS Num 8 FO38: C2a. Days from creatinine blood draw to enrollment

30 GLUCOSE_DAYS Num 8 FO38: C3a. Days from glucose blood draw to enrollment

31 TRIGLY_DAYS Num 8 FO38: C4a. Days from triglycerides blood draw to enrollment

32 AST_DAYS Num 8 FO38: D1b. Days from AST blood draw to enrollment

33 ALT_DAYS Num 8 FO38: D2b. Days from ALT blood draw to enrollment

34 ALK_DAYS Num 8 FO38: D3b. Days from alkaline phosphatase blood draw to enrollment

35 BILI_DAYS Num 8 FO38: D4a. Days from bilirubin blood draw to enrollment

36 ALBUMIN_DAYS Num 8 FO38: D5a. Days from albumin blood draw to enrollment


Num Variable Type Len Format Informat Label 37 GLOBULIN_DAYS Num 8 FO38: D6a. Days from globulin or total protein blood draw to enrollment

38 PT_DAYS Num 8 FO38: E1a. Days from prothrombin time blood draw to enrollment




2 GEN_HEALTH Num 8 X449F. 3. FO40: B1. In general health is

3 HEALTH_COMP Num 8 X478F. 3. FO40: B2. One year comparison

4 VIGOROUS Num 8 X548F. 3. FO40: B3a. Vigorous activities

5 MODERATE Num 8 X548F. 3. FO40: B3b. Moderate activities

6 LIFTING Num 8 X548F. 3. FO40: B3c. Lifting or carrying groceries

7 SEV_FLIG Num 8 X548F. 3. FO40: B3d. Several flights of stairs

8 ONE_FLIG Num 8 X548F. 3. FO40: B3e. One flight of stairs

9 BENDING Num 8 X548F. 3. FO40: B3f. Bending, kneeling, stooping

10 WALKING_ONE Num 8 X548F. 3. FO40: B3g. Walking more than a mile

11 WALKING_SEV Num 8 X548F. 3. FO40: B3h. Walking several blocks

12 WALKING_BLO Num 8 X548F. 3. FO40: B3i. Walking one block

13 BATHING Num 8 X548F. 3. FO40: B3j. Bathing or dressing

14 PH_CUT_WORK Num 8 X550F. 3. FO40: B4a. Cut down time on work or other activities

15 PH_ACC_LESS Num 8 X550F. 3. FO40: B4b. Accomplish less

16 PH_WORK_LIM Num 8 X550F. 3. FO40: B4c. Limited in kind of work

17 PH_WORK_DIFF Num 8 X550F. 3. FO40: B4d. Had difficulty performing work

18 EM_CUT_WORK Num 8 X550F. 3. FO40: B5a. Cut down on work or other activities

19 EM_ACC_LESS Num 8 X550F. 3. FO40: B5b. Accomplished less

20 EM_OTH_ACT Num 8 X550F. 3. FO40: B5c. Couldn't work as carefully as usual

21 EMOT Num 8 X490F. 3. FO40: B6. Physical health or emotional problems

22 BODILY Num 8 X485F. 3. FO40: B7. Bodily pain

23 INTERFERE Num 8 X490F. 3. FO40: B8. Pain interference

24 FULL_PEP Num 8 X432F. 3. FO40: B9a. Full of pep

25 NERVOUS Num 8 X432F. 3. FO40: B9b. Nervous person

26 DUMPS Num 8 X432F. 3. FO40: B9c. Down in dumps

27 CALM Num 8 X432F. 3. FO40: B9d. Calm and peaceful

28 ENERGY Num 8 X432F. 3. FO40: B9e. Lot of energy

29 DOWNHEARTED Num 8 X432F. 3. FO40: B9f. Downhearted and blue

30 WORN_OUT Num 8 X432F. 3. FO40: B9g. Worn out

31 HAPPY Num 8 X432F. 3. FO40: B9h. Happy person

32 TIRED Num 8 X432F. 3. FO40: B9i. Tired

33 FRIENDS_VIS Num 8 X433F. 3. FO40: B10. Interference with social activities?

34 SICK_EASY Num 8 X443F. 3. FO40: B11a. Sick easier

35 HEALTHY Num 8 X443F. 3. FO40: B11b. Healthy as anybody

36 HEALTH_WORSE Num 8 X443F. 3. FO40: B11c. Health worse


Num Variable Type Len Format Informat Label 37 HEALTH_EXC Num 8 X443F. 3. FO40: B11d. Health excellent

38 SLEEP Num 8 X433F. 3. FO40: B12a. Trouble sleeping

39 WAKE_UP_REST Num 8 X433F. 3. FO40: B12b. Wake up rested

40 WAKE_DAY Num 8 X433F. 3. FO40: B12c. Problems awake in day

41 TEMPER Num 8 X433F. 3. FO40: B13a. Short tempered

42 UPSET Num 8 X433F. 3. FO40: B13b. Moody or upset

43 CONCENTRATE Num 8 X433F. 3. FO40: B13c. Trouble concentrating

44 ISOLATE Num 8 X433F. 3. FO40: B14a. Felt isolated

45 SOCIALISE Num 8 X433F. 3. FO40: B14b. Reluctant to socialize

46 RELATIONSHIP Num 8 X433F. 3. FO40: B14c. Strained relationships

47 WORK_PER Num 8 X488F. 3. FO40: B15a. Work performance

48 FIN_PROB Num 8 X488F. 3. FO40: B15b. Financial Problems

49 NO_WORK_HEA Num 8 X488F. 3. FO40: B15c. Unable to work because of health

50 SEX_INTR Num 8 X489F. 3. FO40: B16a. Sex enjoyment

51 SEX_INTEREST Num 8 X488F. 3. FO40: B16b. Sex interest

52 SEX_PERFORM Num 8 X489F. 3. FO40: B16c. Sex performance

53 HOMEMAKER Num 8 X438F. 3. FO40: B17a. Ability to function at work ...

54 SOCIAL_LIFE Num 8 X438F. 3. FO40: B17b. Social life

55 LIFE_OVERALL Num 8 X438F. 3. FO40: B17c. Life overall





Num Variable Type Len Format Informat Label 1 LIFETIME Num 8 X550F. 3. FO41: B1. Patient drink ever

2 P Num 8 Number of phases

3 PH_AGE_LOW1 Num 8 Phase 1 Low Age













16 PH_AGE_HIGH1 Num 8 Phase 1 High Age













29 DR_P_DAY1 Num 8 Phase 1 Avg Drinks Per Day









Num Variable Type Len Format Informat Label 37 DR_P_DAY9 Num 8 Phase 9 Avg Drinks Per Day





42 MAX_DRINKS1 Num 8 Phase 1 Max Drinks Per Day













55 DAYS_PER_MTH1 Num 8 Phase 1 days per month













68 BEERPC1 Num 8 Phase 1 Beer %









Num Variable Type Len Format Informat Label 76 BEERPC9 Num 8 Phase 9 Beer %





81 LIQUORPC1 Num 8 Phase 1 Liquor %













94 WINEPC1 Num 8 Phase 1 Wine %













107 DRINK_STYLE1 Num 8 STYLEF. Phase 1 drinking style









Num Variable Type Len Format Informat Label 115 DRINK_STYLE9 Num 8 STYLEF. Phase 9 drinking style





120 LIFE_EVENTS1 Num 8 X550F. Phase 1 life events













133 YEARS_PH1 Num 8 Phase 1 duration













146 DRINK_P_M1 Num 8 Phase 1 drinks per month









Num Variable Type Len Format Informat Label 154 DRINK_P_M9 Num 8 Phase 9 drinks per month





159 BEER_P_M1 Num 8 Phase 1 beers per month













172 LIQU_P_M1 Num 8 Phase 1 liquor per month













185 WINE_P_M1 Num 8 Phase 1 wine per month









Num Variable Type Len Format Informat Label 193 WINE_P_M9 Num 8 Phase 9 wine per month





198 DRINK_P_PH1 Num 8 Phase 1 total drinks













211 BEER_P_PH1 Num 8 Phase 1 total beer













224 LIQU_P_PH1 Num 8 Phase 1 total liquor









Num Variable Type Len Format Informat Label 232 LIQU_P_PH9 Num 8 Phase 9 total liquor





237 WINE_P_PH1 Num 8 Phase 1 total wine













250 STYLE_YR_ABST Num 8 Years drinking style = abstinent

251 STYLE_YR_OCCA Num 8 Years drinking style = occasional

252 STYLE_YR_WKND Num 8 Years drinking style = weekend

253 STYLE_YR_BING Num 8 Years drinking style = binge

254 STYLE_YR_FREQ Num 8 Years drinking style = frequent

255 STYLE_YRS Num 8 Total of style years

256 MAXAVDRPDY Num 8 Max of av drinks per day

257 MAXMAXDR Num 8 Max of max drinks per day

258 MAXDYPMO Num 8 Max of day per month

259 AVGDYPMO Num 8 Average of days per month

260 MAXDRPMO Num 8 Max of drinks per month

261 MAXBEPMO Num 8 Max of beer per month

262 MAXLIPMO Num 8 Max of liquor per month

263 MAXWIPMO Num 8 Max of wine per month

264 LIFE_DRINKS Num 8 Total drinks - lifetime

265 DRINKS_B Num 8 Total drinks beer - lifetime

266 DRINKS_L Num 8 Total drinks liquor - lifetime

267 DRINKS_W Num 8 Total drinks wine - lifetime

268 AGE_START Num 8 Age first drank

269 AGE_END Num 8 Age last drank

270 YEARS_DRANK1 Num 8 Years drank: ST - END


Num Variable Type Len Format Informat Label 271 YEARS_DRANK2 Num 8 Years drank: sum with 0

272 YEARS_DRANK3 Num 8 Years drank: sum without 0

273 AVE_DRINK_YEAR Num 8 Av drinks / year

274 AVE_BEER_YEAR Num 8 Av beer / year

275 AVE_LIQU_YEAR Num 8 Av liquor / year

276 AVE_WINE_YEAR Num 8 Av wine / year


278 AVE_GRAMS_P_M Num 8 Av gms of alcohol/month

279 AVE_GRAMS_P_Y Num 8 Av gms of alcohol/year

280 AVE_DRINKS_P_D Num 8 Av drinks of alcohol/day

281 AVE_DRINKS_P_M Num 8 Av drinds of alcohol/month

282 AVE_DRINKS_P_Y Num 8 Av drinks of alcohol/year

283 DRINK_STAT Num 8 DRISTATF. Drinking status (0-12,13-156,157-720,>720 g/m)






2 DRINK_SCO Num 8 X484F. 3. FO42: B1. Usual intake of alcohol

3 DRINK_5 Num 8 X550F. 3. FO42: B2. More than 5 drinks per day?

4 DRINK_DAYS Num 8 DDAYCATF. 4. FO42: B3 How many days? (Categorical)






2 FATIGUE Num 8 X582F. 5.1 FO43: B1a. Fatigue Score

3 NAUSEA Num 8 X582F. 5.1 FO43: B1b. Nausea score

4 LIVER Num 8 X582F. 5.1 FO43: B1c. Pain of liver area score

5 APPETITE Num 8 X582F. 5.1 FO43: B1d. Appetite Score

6 HEADACHE Num 8 X582F. 5.1 FO43: B1e. Headache score

7 MUSCLE Num 8 X582F. 5.1 FO43: B1f. Muscle/joint aches or pains score

8 ITCHINESS Num 8 X582F. 5.1 FO43: B1g. Itchiness Score

9 IRRITABILITY Num 8 X582F. 5.1 FO43: B1h. Irritability Score

10 DEPRESSION Num 8 X582F. 5.1 FO43: B1i. Depression score

11 FEEL_OVERALL Num 8 X582F. 5.1 FO43: B2. Overall Feel Score




Data Set Name: form044_bdi.sas7bdat


2 SADNESS Num 8 X582F. 3. FO44: B1. Sadness

3 PESSI Num 8 X582F. 3. FO44: B2. Pessimism

4 FAILURE Num 8 X582F. 3. FO44: B3. Past Failure

5 PLEASURE Num 8 X582F. 3. FO44: B4. Loss of pleasure

6 GUILT Num 8 X582F. 3. FO44: B5. Guilty feelings

7 PUNISH Num 8 X582F. 3. FO44: B6. Punishment feelings

8 DISLIKE Num 8 X582F. 3. FO44: B7. Self-Dislike

9 CRITIC Num 8 X582F. 3. FO44: B8. Self-Criticalness

10 SUIC Num 8 X582F. 3. FO44: B9. Suicidal Thoughts

11 CRY Num 8 X582F. 3. FO44: B10. Crying

12 AGIT Num 8 X582F. 3. FO44: B11. Agitation

13 INTEREST Num 8 X582F. 3. FO44: B12. Loss of Interest

14 INDECIS Num 8 X582F. 3. FO44: B13. Indecisiveness

15 WORTHLESS Num 8 X582F. 3. FO44: B14. Worthlessness

16 ENERGY Num 8 X582F. 3. FO44: B15. Loss of Energy

17 SLEEP Num 8 X582F. 3. FO44: B16a. Changes in Sleep Pattern

18 SLEEP_SPEC Char 2 $2. $2. FO44: B16b. Specify a or b

19 IRRITABLE Num 8 X582F. 3. FO44: B17. Irritability

20 APPETITE Num 8 X582F. 3. FO44: B18a. Changes on appetite

21 APPETITE_SPE Char 2 $2. $2. FO44: B18b. Specify a or b

22 CONCEN Num 8 X582F. 3. FO44: B19. Concentration Difficulty

23 TIRED Num 8 X582F. 3. FO44: B20. Tiredness or fatigue

24 SEX Num 8 X582F. 3. FO44: B21. Loss of interest in sex

25 SCORE Num 8 X582F. 3. FO44: B22. Score






2 MARITAL Num 8 X472F. 3. FO45: B1. Current marital status

3 HOUSING Num 8 X427F. 3. FO45: B3. Housing type

4 SITUATION Num 8 X544F. 3. FO45: B4. Situation description

5 UNEMPLOYED Num 8 X470F. 3. FO45: B5. Has the patient been?

6 HEALTH_REAS Num 8 X550F. 3. FO45: B6. Situation changed because of health

7 INS_MEDAID Num 8 X558F. 3. FO45: B7a. Medicaid

8 INS_MEDICARE Num 8 X558F. 3. FO45: B7b. Medicare

9 INS_HMO Num 8 X558F. 3. FO45: B7c. HMO

10 INS_PRIVATE Num 8 X558F. 3. FO45: B7d. Private Insurance

11 INS_OTHER Num 8 X558F. 3. FO45: B7e. Other insurance

12 HIGH_GRADE Num 8 X464F. 3. FO45: C1. Highest grade or year of school completed



15 LIVE_N Char 2 FO45: B2. How many people in household including self



Num Variable Type Len Format Informat Label 1 BIOPSY_SPEC Num 8 X550F. 3. FO50: B3. Biopsy performed specifically for the trial?

2 ISH_SCO Num 8 X411F. 3. FO50: C3. Ishak fibrosis score - Ver. A/B

3 HEPATO_IRON Num 8 X511F. 3. FO50: C6. 3+ or 4+ hepatocellular iron

4 BLOCK_NUM Num 8 X550F. 3. FO50: C10. Is the block available at the site?

5 STEATO_H Num 8 X550F. 3. FO50: C4. Steatohepatitis

6 STEATO_SEV Num 8 X550F. 3. FO50: C5. Is the steatohepatitis severe

7 ISHAK_SCORE Num 8 X582F. 3. FO50: C3. Ishak fibrosis score - Ver. C

8 PREV_SCORE Num 8 X550F. 3. FO50: C3b. Previous biopsy with Ishak score of 3 or greater?

9 EVENTTYPE_ID Char 4 $4. $4. FO50: A3. Visit


11 BIOPSY_DAYS Num 8 FO50: B2. Biopsy date - days before enrollment

12 COURSE_DAYS Num 8 FO50: B1. Most recent treatment - days before enrollment



Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 4 $3. $4. FO51: A3. Visit number

2 BIOPSY_ID Num 8 X582F. 7. FO51: A6. Biopsy Dummy ID

3 NUM_PATHOL Num 8 X582F. 3. FO51: B1. How many pathologists read the biopsy?

4 SPEC_LENGTH Num 8 X582F. 5.1 FO51: B3. Specimen length

5 ADEQUATE Num 8 X550F. 3. FO51: B4. Adequate for grading and staging?

6 PERI_ISHAK Num 8 X582F. 3. FO51: C4c. Periportal - Ishak

7 PERI_KNODELL Num 8 X582F. 3. FO51: C4d. Periportal - Knodell

8 CONFLU_ISHAK Num 8 X582F. 3. FO51: C9. Confluent necrosis - Ishak

9 PAREN_ISHAK Num 8 X582F. 3. FO51: C4e. Parenchymal injury - Ishak

10 PAREN_KNODEL Num 8 X582F. 3. FO51: C4f. Parenchymal injury - Knodell

11 PORTAL_ISHAK Num 8 X582F. 3. FO51: C4a. Portal inflammation - Ishak

12 PORTAL_KNODE Num 8 X582F. 3. FO51: C4b. Portal inflammation - Knodell

13 INFLAM_METAV Num 8 X582F. 3. FO51: C4g. Inflammatory activity - Metavir

14 FIBRO_ISHAK Num 8 X582F. 3. FO51: C1a. Fibrosis - Ishak

15 FIBRO_KNODEL Num 8 X582F. 3. FO51: C1b. Fibrosis - Knodell

16 FIBRO_METAVI Num 8 X582F. 3. FO51: C1c. Fibrosis - Metavir

17 FAT Num 8 X402F. 3. FO51: C2. Fat

18 IRON_GRADE Num 8 X582F. 3. FO51: C11. Hepatocellular Iron Grade

19 LARGE_CELL Num 8 X511F. 3. FO51: C5a. Large cell change

20 SMALL_CELL Num 8 X511F. 3. FO51: C5b. Small cell change

21 BILE_DUCT Num 8 X511F. 3. FO51: C6. Bile duct lesions

22 LYMPHOID Num 8 X511F. 3. FO51: C7. Lymphoid follicles

23 MALLORY_A Num 8 X511F. 3. FO51: C8. Mallory bodies (Ver A)

24 MALLORY_B Num 8 X577F. 3. FO51: C8. Mallory bodies (Ver B/C)

25 ZONE_3 Num 8 X578F. 3. FO51: C3. Zone 3 pericellular fibrosis



Data Set Name: form052.sas7bdat Num Variable Type Len Format Informat Label

1 VISIT_NUM Char 3 $3. $3. FO52: A3. Visit Number

2 BIOP_ADE Num 8 X550F. 3. FO52: C3. Biopsy adequate

3 BLOCK_AVAIL Num 8 X550F. 3. FO52: C6. Block at site


5 BIOPSY_DAYS Num 8 FO51: B1. Biopsy date - days since enrollment




2 BIOPSYAREA Num 8 X582F. 9.4 FO53: B1. Biopsy area

3 COLLAGEN Num 8 X582F. 9.4 FO53: B2. Collagen




Num Variable Type Len Format Informat Label 1 TUMOR_TYPE Num 8 TUMORF. 3. FO56: B1. Hepatic tumor type

2 ED_GRADE Num 8 X419F. 3. FO56: B2. Edmondson grade




Num Variable Type Len Format Informat Label 1 OUTCOME_CODE Num 8 X442F. 3. FO63: B2. Clinical outcome code

2 ADVERSEVENT Num 8 X550F. 3. FO63: B0. Is this clinical outcome considered an Adverse Event?

3 OUTCOME_NUM Num 8 4. 4. OUTCOME_NUM


5 COMP_DAYS Num 8 FO63: A3. Form completion date - days since enrollment



Num Variable Type Len Format Informat Label 1 RECORD_SUM Num 8 X550F. 3. FO64: B7. Is hospital record summary report available?

2 DEATH_CERT Num 8 X550F. 3. FO64: C1. Is a copy of the death certificate available?

3 I_FAMILY Num 8 X550F. 3. FO64: C8a. Family member

4 I_MEDICAL Num 8 X550F. 3. FO64: C8b. Medical personnel

5 I_HOSPITAL Num 8 X550F. 3. FO64: C8c. Hospital records

6 I_DEATHCERT Num 8 X550F. 3. FO64: C8d. Death certificate

7 I_OTHER Num 8 X550F. 3. FO64: C8f. Other source of information

8 HEPC_REL Num 8 X550F. 3. FO64: D1a. Cause of death classified as Hepatitis C related

9 LIVER_REL Num 8 X550F. 3. FO64: D1b. Cause of death classified as liver related

10 OTHER_REL Num 8 X550F. 3. FO64: D1d. Cause of death classified as other

11 UNKNOWN Num 8 X550F. FO64 D1e/f. Cause of death classified as unknown


13 DEATH_DAYS Num 8 FO64: B2. # days from enrollment to death



Num Variable Type Len Format Informat Label 1 OUTCOME_NUM Num 8 X582F. 4. FO65: A5. Clinical outcome number

2 OUTCOME_CODE Num 8 X442F. 3. FO65: B2. Clinical outcome code

3 OUTCOME_A Num 8 X442F. 3. FO65: F2. Type of outcome (code)

4 MET_A Num 8 X550F. 3. FO65: F3. Has the clinical outcome been met?

5 NOTMEET_A Num 8 X550F. 3. FO65: F5a. Although present, condition does not meet outcome criteria

6 SOURCEDOC_A Num 8 X550F. 3. FO65: F5b. Inadequate or incorrect source documentation

7 OTH_REAS_A Num 8 X550F. 3. FO65: F5c. Other

8 OUTCOME_B Num 8 X442F. 3. FO65: G2. Type of outcome (code)

9 MET_B Num 8 X550F. 3. FO65: G3. Has the clinical outcome been met?

10 NOTMEET_B Num 8 X550F. 3. FO65: G5a. Although present, condition does not meet outcome criteria

11 SOURCEDOC_B Num 8 X550F. 3. FO65: G5b. Inadequate or incorrect source documentation

12 OTH_REAS_B Num 8 X550F. 3. FO65: G5c. Other

13 NEED_REV_C Num 8 X550F. 3. FO65: H1. Is a third reviewer needed for this outcome?

14 OUTCOME_C Num 8 X442F. 3. FO65: H3. Type of outcome (code)

15 MET_C Num 8 X550F. 3. FO65: H4. Has the clinical outcome been met?

16 NOTMEET_C Num 8 X550F. 3. FO65: H6a. Although present, condition does not meet outcome criteria

17 SOURCEDOC_C Num 8 X550F. 3. FO65: H6b. Inadequate or incorrect source documentation

18 OTH_REAS_C Num 8 X550F. 3. FO65: H6c. Other

19 ASSESSMENT Num 8 X550F. 3. FO65: I2. Was the clinical outcome met?


21 REC_DAYS Num 8 FO65: B1. Days from enrollment clinical outcome information received by DCC

22 METCRIT_DAYS Num 8 FO65: F4. Days from enrollment patient met criteria for the outcome

23 METCRIT_DAYS_B Num 8 FO65: G4. Days from enrollment patient met criteria for the outcome

24 METCRIT_DAYS_C Num 8 FO65: H5. Days from enrollment patient met criteria for the outcome

25 RESULT_DAYS Num 8 FO65: I3. Days from enrollment patient met criteria for the outcome



Num Variable Type Len Format Informat Label 1 HISTOLOGY Num 8 X550F. 3. FO66: B2. Was diagnosis made on basis of histology

2 NODULES Num 8 X420F. 3. FO66: C1. Number of tumor nodules in the liver

3 TUMORSIZE Num 8 X582F. 5.1 FO66: C2. Tumor size

4 LOCATION Num 8 X540F. 3. FO66: C3. Tumor location

5 VASC_INV Num 8 X563F. 3. FO66: C4. Vascular invasion

6 SPEED Num 8 X563F. 3. FO66: C5. Extrahepatic spread

7 T_FACTOR Char 3 $3. $3. FO66: C6a. T-factor

8 N_FACTOR Char 3 $3. $3. FO66: C6b. N-factor

9 M_FACTOR Char 3 $3. $3. FO66: C6c. M-factor


11 COMP_DAYS Num 8 FO66: A3. # days from enrollment to form completed

12 HCC_DAYS Num 8 FO66: B1.# days from enrollment to Date patient met criteria



Num Variable Type Len Format Informat Label 1 DIAG_HCC Num 8 X550F. 3. FO67: C1. Diagnosed to have HCC prior to transplant

2 PATH_HCC Num 8 X550F. 3. FO67: C2. HCC in the explant liver


4 LIST_DAYS Num 8 FO67: B1. # days from enrollment to list

5 TRANS_DAYS Num 8 FO67: B2.# days from enrollment to transplant?



Num Variable Type Len Format Informat Label 1 NO_TUM_IMAGE Num 8 X536F. 3. FO69: B1a. Type of imaging

2 SUSP_IMAGE Num 8 X536F. 3. FO69: B2a. Type of imaging

3 SUSP_NODULE Num 8 X420F. 3. FO69: B2b. Number of tumor nodules in the liver

4 SUSP_SIZE Num 8 X401F. 5.1 FO69: B2c. Size of largest nodules

5 SUSP_LOCATN Num 8 X522F. 3. FO69: B2d. Nodule location

6 SUSP_INV Num 8 X564F. 3. FO69: B2e. Portal vein invasion or thrombus

7 SUSP_SPREAD Num 8 X564F. 3. FO69: B2f. Extrahepatic spread

8 HCC_TX Num 8 X550F. 3. FO69: C1. Has the patient received any treatment for HCC

9 TRANSPL Num 8 X550F. 3. FO69: C2b1. Liver transplantation

10 ART_CHEMO Num 8 X550F. 3. FO69: C2e1. Intra-arterial chemotherapy

11 RADIATN Num 8 X550F. 3. FO69: C2g1. Radiation therapy


13 COMP_DAYS Num 8 FO69: A3.# days from enrollment to date form completed

14 NO_TUM_DAYS Num 8 FO69: B1.# days from enrollment to the date when last imaging show no tumor nodule

15 SUSP_DAYS Num 8 FO69: B2.# days from enrollment to the date when imaging first showed a suspicious nodule

16 RESECT_DAYS Num 8 FO69: C2a2.# days from enrollment to surgical resection date

17 TRANSPL_DAYS Num 8 FO69: C2b2.# days from enrollment to liver transplantation date

18 RFREQ_DAYS Num 8 FO69: C2c2.# days from enrollment to local ablation (radiofrequency) date

19 ALC_DAYS Num 8 FO69: C2d2.# days from enrollment to local ablation (injection of alcohol) date

20 ACHEMO_DAYS Num 8 FO69: C2e2.# days from enrollment to intra-arterial chemotherapy date

21 S_CHEMO_DAYS Num 8 FO69: C2f2.# days from enrollment to dystemic chemotherapy date

22 RADIATN_DAYS Num 8 FO69: C2g2.# days from enrollment to radiation therapy date

23 OTH_TX_DAYS Num 8 FO69: C2h3.# days from enrollment to the other treatment date





3 RAND_DAYS Num 8 FO98: B1. # of days from enrollment date to Randomization Visit (R00)




2 ISH_SCO Num 8 X421F. 3. FO99: B1. Ishak fibrosis score from central review of entry biopsy

3 RAND_ELIG Num 8 X546F. 3. FO99: B7. Is patient eligible for randomization?


5 RAND_DAYS Num 8 # of days from enrollment date to randomization



Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 3 $3. $3. F110: A3. Visit Number

2 DUMMY_ID Char 5 $5. $5. F110: A6. Dummy ID

3 ENDO Num 8 X550F. 3. F110: B1. Is this Endoscopy adequate for evaluation

4 ESO_VIEW Num 8 X550F. 3. F110: B2b. Which views: Esophagus

5 RETRO_VIEW Num 8 X550F. 3. F110: B2c. Which views:Retroflex

6 MID_VIEW Num 8 X550F. 3. F110: B2d. Which views: Midbody of stomach

7 ALL_VIEW Num 8 X550F. 3. F110: B2a. Which views: All

8 ESO_EVAL Num 8 X566F. 3. F110: B3. Was there evidence of esophageal varices?

9 ESO_GRADE Num 8 F110ESOGF. 3. F110: B3a. Grade of esophageal varices

10 GASTRIC_EVAL Num 8 X566F. 3. F110: B4. Was there evidence of gastric varices?

11 GASTRIC_TYPE Num 8 F110GASF. 3. F110: B4a. Type of gastric varices

12 FIND_OTH Num 8 X550F. 3. F110: B5. Were there any other findings




Num Variable Type Len Format Informat Label 1 VISIT_NUM Char 4 $4. $4. F505: e. Visit Number

2 UNSTAINED_R Num 8 3. 3. F505: k. # Unstained slides

3 STAINED_R Num 8 3. 3. F505: l. # Stained slides

4 liver_id Char 4 $4. $4. F505: m. Liver Biopsy ID





2 CHNG_OUTCOME Num 8 X550F. 3. F610: B1. Has patient had any changes in health

3 ANTIV_MED Num 8 X550F. 3. F610: C1. Has patient taken antiviral medication for Hepatitis C


5 VISIT_DAYS Num 8 F610: A4. # of days from enrollment to the visiting dates




2 WEIGHT_KG Num 8 X401F. 6.1 F611: B1a. Weight:

3 BP1 Num 8 X401F. 4. F611: B2a. Blood Pressure: systolic

4 BP2 Num 8 X401F. 4. F611: B2b. Blood Pressure: diastolic

5 PULSE Num 8 X401F. 4. F611: B3. Pulse

6 GEN_APP Num 8 X487F. 3. F611: B4. General Appearance

7 HEAD Num 8 X487F. 3. F611: B5. Head

8 EARS Num 8 X487F. 3. F611: B6. Ears, Nose, Throat

9 EYES Num 8 X487F. 3. F611: B7. Eyes

10 NECK Num 8 X487F. 3. F611: B8. Neck

11 LYMPH Num 8 X487F. 3. F611: B9. Lymph Nodes

12 SKIN Num 8 X487F. 3. F611: B10. Skin

13 LUNGS Num 8 X487F. 3. F611: B11. Lungs

14 HEART Num 8 X487F. 3. F611: B12. Heart

15 ABDOMEN Num 8 X487F. 3. F611: B13. Abdomen

16 MUSCULO Num 8 X487F. 3. F611: B14. Musculoskeletal

17 NEUROLOGIC Num 8 X487F. 3. F611: B15. Neurologic

18 BREASTS Num 8 X487F. 3. F611: B16. Breasts

19 RECTAL Num 8 X487F. 3. F611: B17. Rectal

20 PELVIC Num 8 X487F. 3. F611: B18. Pelvic

21 HEPATO Num 8 X550F. 3. F611: C1. Hepatomegaly

22 SPLENO Num 8 X550F. 3. F611: C2. Spleen palpable

23 ASCITES Num 8 X550F. 3. F611: C3. Ascites

24 ASCITES_SEV Num 8 X475F. 3. F611: C3a. Ascites severity

25 JAUNDICE Num 8 X511F. 3. F611: C4. Jaundice

26 ENCEPH Num 8 X550F. 3. F611: C5. Encephalopathy

27 ENCEPH_GRADE Num 8 X401F. 3. F611: C5a. Encephalopathy grade:

28 EDEMA Num 8 X550F. 3. F611: C6. Edema

29 FINDINGS Num 8 X550F. 3. F611: D1. Are there new findings at this visit

30 HEPATO_SPAN Char 3 F611: C1a. Span (Right midclavicular line)

31 EDEMA_SEV Char 2 F611: C6a. Edema Severity





Num Variable Type Len Format Informat Label 1 VISIT_NO Char 4 $4. $4. F615: A3. Visit Number

2 SER_ALB Num 8 X426F. 3. F615: B1. Points for serum albumin (g/dL) (Score 1-3)

3 SER_TOT Num 8 X424F. 3. F615: B2. Serum total bilirubin (Score 1-3)

4 PRO_TIME Num 8 X423F. 3. F615: B3. Prothrombin Time (Score 1-3)

5 ASCITES Num 8 X483F. 3. F615: B4. Ascites score (1-3)

6 ENCEPH Num 8 X483F. 3. F615: B5. Encephalopathy score (1-3)

7 TOTAL_SCORE Num 8 X582F. 3. F615: B6. Total Score (5 - 15)






2 TEST_TYPE Num 8 X535F. 3. F622: B2. Test performed was

3 ASC_EVID Num 8 X550F. 3. F622: B3. Ascites evidence

4 LIVER_MASS Num 8 X550F. 3. F622: B4. Evidence of a liver mass?

5 DEF_LIV Num 8 X405F. 3. F622: B4b. Is the liver mass?

6 PRIOR_REP Num 8 X550F. 3. F622: B4c. Are there prior films or a report available

7 FU_LIVER Num 8 X550F. 3. F622: B4e. Does liver mass require further follow-up

8 EVID_SPLENO Num 8 X557F. 3. F622: B5. Was there evidence of splenomegaly

9 OTH_FIN Num 8 X550F. 3. F622: B6. Any other findings?

10 SPLEEN_SIZE Char 3 FO622: B5a. Greatest length of spleen in any dimension


12 max_diac Num 8 MAXDIAMF. FO622: B4a. Maximum diameter of liver mass? (Categorical)

13 ULTRA_DAYS Num 8 FO622: B1. Imaging test: # days since enrollment

14 FU_DAYS Num 8 FO622: B4i. Follow-up test: # days since enrollment




2 WBC Num 8 X401F. 5.1 F630: B1. WBC

3 NEUTOPHILS Num 8 X401F. 7.3 F630: B2. Neutrophils

4 HEMATOCRIT Num 8 X401F. 5.1 F630: B3. Hematocrit

5 HEMOGLOBIN Num 8 X401F. 5.1 F630: B4. Hemoglobin

6 PLATELETS Num 8 X401F. 4. F630: B5. Platelets

7 CREATININE Num 8 X401F. 5.1 F630: C1. Creatinine

8 AST Num 8 X401F. 5. F630: D1. AST (SGOT)

9 UPPER_AST Num 8 X401F. 4. F630: D1a. Upper limit of normal (from lab report):

10 ALT Num 8 X401F. 5. F630: D2. ALT (SGPT)

11 UPPER_ALT Num 8 X401F. 4. F630: D2a. Upper limit of normal (from lab report):

12 ALKALINE Num 8 X401F. 5. F630: D3. Alkaline phosphatase

13 UPPER_ALKALI Num 8 X401F. 4. F630: D3a. Upper limit of normal (from lab report):

14 TOT_BILIRUBI Num 8 X401F. 6.1 F630: D4. Total bilirubin

15 ALBUMIN Num 8 X401F. 6.1 F630: D5. Albumin

16 GLOBULIN Num 8 X401F. 6.1 F630: D6. Globulin

17 TOT_PROTEIN Num 8 X401F. 6.1 F630: D7. Total Protein

18 PROTHROMBIN Num 8 X401F. 5.1 F630: E1. Prothrombin Time

19 AFP Num 8 X401F. 8.2 F630: F1. AFP Result:

20 UPPER_AFP Num 8 X401F. 8.2 F630: F2. Upper limit of normal

21 fast_hours Num 8 Hours fasting to blood draw



24 BLOOD_DAYS Num 8 F630: A6. # of days from enrollment to the date of blood draw run




2 HAVE_RESLT Num 8 X550F. 3. F631: B1. Are there any results HCV RNA assay since last visit.

3 ASSAY1 Num 8 X477F. 3. F631: C1. Assay performed

4 HCV_RESULT1 Num 8 X444F. 3. F631: C2. HCV RNA Status

5 SEC_TEST Num 8 X550F. 3. F631: C5. Any other HCV-RNA result

6 ASSAY2 Num 8 X477F. 3. F631: D1. Assay performed 2nd

7 HCV_RESULT2 Num 8 X444F. 3. F631: D2. HCV RNA Status 2nd


9 COMP_DAYS Num 8 F631: A4. # of days from enrollment to the form completion date

10 BLOOD_DAYS Num 8 F631: B2. # of days from enrollment to the date of blood draw run



Num Variable Type Len Format Informat Label 1 OBT_INFO Num 8 X550F. 3. F924: B1. Was site able to obtain information since last study visit

2 HOSP_NITE Num 8 X550F. 3. F924: B2. Was the patient admitted to the hospital overnight

3 LIV_IMAGE Num 8 X550F. 3. F924: B3. Has the patient had any liver related imaging

4 LIV_BIOPSY Num 8 X550F. 3. F924: B4. Has the patient had a liver biopsy

5 ENDOSCOPY Num 8 X550F. 3. F924: B5. Has the patient had an endoscopy

6 HLTH_CHANGE Num 8 X550F. 3. F924: B6. Has the patient had any changes in his/her health

7 REQ_DOC Num 8 X550F. 3. F924: B7. Are you requesting source documentation

8 INTERFERON Num 8 X550F. 3. F924: C1. Is the patient currently taking any kind of interferon

9 VISIT_NUM Char 4 $4. $4. F924: A3. Study Visit


11 CONTACT_DAYS Num 8 F924: A3. Contact date - days since enrollment

12 INTSTART_DAYS Num 8 F924: C4. Start of interferon - days since enrollment



Num Variable Type Len Format Informat Label 1 NUM_REV Num 8 3. 3. F964: A4. Number of reviewers

2 OUTCOME_NUM Num 8 4. 4. OUTCOME_NUM

3 PRI_CAUSE Num 8 PRICAU. 3. F964: B1. PRI_CAUSE

4 HEPC Num 8 CAUDEATH. 3. F964: B2. HEPC related disease cause death?

5 HEPC_LH Num 8 LKHOOD. 3. F964: B2a. Likelihood that HEPC cause death


7 COMP_DAYS Num 8 F964: A3.# days from enrollment to date of review



Num Variable Type Len Format Informat Label 1 CNO_T_IMAGE Num 8 X536F. 3. F969: B1a. Type of imaging

2 CSUSP_IMAGE Num 8 X536F. 3. F969: B2a. Type of imaging

3 C_SNODULES Num 8 X420F. 3. F969: B2b. Number of tumor nodules in the liver

4 C_SUSP_SIZE Num 8 X401F. 5.1 F969: B2c. Size of largest nodules

5 C_SLOCATION Num 8 X522F. 3. F969: B2d. Nodule location

6 C_SUSP_INV Num 8 X564F. 3. F969: B2e. Portal vein invasion

7 C_SUS_SPREAD Num 8 X564F. 3. F969: B2f. Extrahepatic spread

8 C_HCC_IMAGE Num 8 X537F. 3. F969: B3a. Type of imaging

9 C_HCC_NODULE Num 8 X420F. 3. F969: B3b. Number of tumor nodules in the liver

10 C_HCC_SIZE Num 8 X401F. 5.1 F969: B3c. Size of largest nodules

11 C_HCC_LOCATN Num 8 X522F. 3. F969: B3d. Nodule location

12 C_HCC_INV Num 8 X564F. 3. F969: B3e. Portal vein invasion

13 C_HCC_SPREAD Num 8 X564F. 3. F969: B3f. Extrahepatic spread

14 C_HCC_TX Num 8 X550F. 3. F969: C1. Received any treatment for HCC

15 C_OLT Num 8 X550F. 3. F969: D1. Undergo liver transplant

16 C_OLT_ISHAK Num 8 X550F. 3. F969: D1a. Ishak fibrosis score

17 C_OLTNODULE Num 8 X420F. 3. F969: D1b. Number of tumor nodules in the liver

18 C_OLT_SIZE Num 8 X401F. 5.1 F969: D1c. Nodule size

19 C_T_FACTOR Char 3 $3. $3. F969: E2a. T-factor

20 C_N_FACTOR Char 2 $2. $2. F969: E2b. N-factor

21 C_M_FACTOR Char 2 $2. $2. F969: E2c. M-factor


23 COMP_DAYS Num 8 F969: A3. # Days from enrollment to the form completion date

24 CNO_TUM_DAYS Num 8 F969: B1. # Days from enrollment to the date when last imaging show no tumor nodule

25 CSUSP_DAYS Num 8 F969: B2. # Days from enrollment to the date when the imaging first showed a suspicious nodule

26 C_HCC_DAYS Num 8 F969: B3. # Days from enrollment to the date when the imaging first met criteria for HCC

27 C_TX_DAYS Num 8 F969: C2. # Days from enrollment to the date when HCC treatment first administered

28 VIS_TUM_DAYS Num 8 F969: E1. # Days from enrollment to the date tumor nodule met criteria.


Data Set Name: haltc_meds_code_atc2.sas7bdat

Num Variable Type Len Format Informat Label 1 MCODE2 Char 10 $7. $7. Corrected Medication Code

2 INGRED1 Char 35 $CHAR35. $35. HALT-C code list ingredient1





7 TYPEC Char 4 Code list used, HERB, OTC, or RX

8 NINGRED Num 8 HALT-C medication code number ingredients

9 ATC_CODE1 Char 8 ATC code for ingredient 1





14 ATC_NAME1 Char 44 ATC name for ingredient 1







Num Variable Type Len Format Informat Label 1 PATIENT_GEND Char 2 $2. $2. FO01: B2. Patient's Gender

2 PATIENT_RACE Char 2 $2. $2. FO01: B3. Patient's Race

3 RACE_SOURCE Num 8 X504F. 3. FO01: B3a. Source of race information

4 HISP_LAT Char 2 $2. $2. FO01: B4. Does the patient consider himself/herself to be Hispanic?

5 LAT_SOURCE Num 8 X504F. 3. FO01: B4a. Source of Latino/Hispanic information

6 INTER_TYPE Num 8 INF_TYPEF. 3. FO01: C2. Type of most recent interferon preparation used.

7 INIT_DOSE_MU Num 8 X582F. 5.1 FO01: C3.1. Most recent dose (MU UNITS ONLY)

8 INIT_DOSE_MC Num 8 X582F. 5. FO01: C3.2. Most recent dose (MCG UNITS ONLY)

9 INT_PER_WEEK Num 8 X582F. 3. FO01: C4. Number of times per week of most recent dose.

10 INT_NO_WEEKS Num 8 X582F. 4. FO01: C5. Number of weeks this most recent treatment was given.

11 INT_RIB_USED Num 8 X550F. 3. FO01: C7. Was Ribavirin given with this most recent treatment?

12 INI_DO_RIB Num 8 INIDORIBF. 5. FO01: C8. Initial Ribavirin Dose in mg.

13 RIB_NO_WEEKS Num 8 X582F. 4. FO01: C9. Number of weeks ribavirin given

14 INT_ADJ Num 8 X550F. 3. FO01: C6. Was the dose of interferon adjusted?

15 RIB_ADJ Num 8 X550F. 3. FO01: C10. Was the dose of ribavirin adjusted?

16 DET_NON_RES Num 8 X582F. 3. FO01: C11. How was the patient's non-response to treatment determined?

17 PRIOR_FORM Num 8 X550F. 3. FO01: B0. Has Form #1 previously been completed for this patient?

18 EVENTTYPE_ID Char 4 $4. $4. Visit number


20 inf_TI Num 8 FO01: C1. # of days from start date of most recent treatment with any Interferon to enrollment.

21 age Num 8 Age at enrollment


Data Set Name: form001_new.sas7bdat

Num Variable Type Len Format Informat Label 1 PATIENT_GEND Char 2 $2. $2. FO01: B2. Patient's Gender

2 PATIENT_RACE Char 2 $2. $2. FO01: B3. Patient's Race

3 RACE_SOURCE Num 8 X504F. 3. FO01: B3a. Source of race information

4 HISP_LAT Char 2 $2. $2. FO01: B4. Does the patient consider himself/herself to be Hispanic?

5 LAT_SOURCE Num 8 X504F. 3. FO01: B4a. Source of Latino/Hispanic information

6 INTER_TYPE Num 8 X582F. 3. FO01: C2. Type of most recent interferon preparation used.

7 INIT_DOSE_MU Num 8 X582F. 5.1 FO01: C3.1. Most recent dose (MU UNITS ONLY)

8 INIT_DOSE_MC Num 8 X582F. 5. FO01: C3.2. Most recent dose (MCG UNITS ONLY)

9 INT_PER_WEEK Num 8 X582F. 3. FO01: C4. Number of times per week of most recent dose.

10 INT_NO_WEEKS Num 8 X582F. 4. FO01: C5. Number of weeks this most recent treatment was given.

11 INT_RIB_USED Num 8 X550F. 3. FO01: C7. Was Ribavirin given with this most recent treatment?

12 INI_DO_RIB Num 8 X582F. 5. FO01: C8. Initial Ribavirin Dose in mg.

13 RIB_NO_WEEKS Num 8 X582F. 4. FO01: C9. Number of weeks ribavirin given

14 INT_ADJ Num 8 X550F. 3. FO01: C6. Was the dose of interferon adjusted?

15 RIB_ADJ Num 8 X550F. 3. FO01: C10. Was the dose of ribavirin adjusted?

16 DET_NON_RES Num 8 X582F. 3. FO01: C11. How was the patient's non-response to treatment determined?

17 PRIOR_FORM Num 8 X550F. 3. FO01: B0. Has Form #1 previously been completed for this patient?

18 EVENTTYPE_ID Char 4 $4. $4. Visit number

19 subj_id Num 8 random_ID

20 PATIENT_TYPE Num 8 2. 2. Patient type (1='LEAD' 2='EXPR' 3='BT' 4='RELAP'5='Screened but not enrolled')

21 inf_TI Num 8 FO01: C1. # of days from start date of most recent treatment with any Interferon to enrollment.

22 age Num 8 Age at enrollment

23 comp_age Num 8 FO01: A3. Age of the patient when the form was completed



Num Variable Type Len Format Informat Label 1 CHR_LI_DIS Num 8 X553F. 3. FO03: B1. Chronic Liver Disease

2 STOM_DISEASE Num 8 X553F. 3. FO03: B4. Any other stomach or intestinal disease or abnormality?

3 OTH_BLO_DIS Num 8 X553F. 3. FO03: B7. Any other blood diseases or abnormality?

4 SYS_AUT_DIS Num 8 X553F. 3. FO03: B8. Systemic auto-immune disorder?

5 IMMUNE_DIS Num 8 X553F. 3. FO03: B9. Any other immune system disease or abnormality?

6 MALIGNANCY Num 8 X553F. 3. FO03: B10. A malignancy?

7 LOCAL_MAL Num 8 X553F. 3. FO03: B10a. Was it a local squamous or basal cell cancer?

8 SER_HEART Num 8 X553F. 3. FO03: B11. Serious heart, cerebrovascular or lung disease?

9 OTH_HEART_D Num 8 X553F. 3. FO03: B12. Any other heart disease or abnormality?

10 OTH_LUNG_D Num 8 X553F. 3. FO03: B13. Any other lung disease or abnormality?

11 NER_BRA Num 8 X552F. 3. FO03: B15. Nerve or brain disease?

12 DRU_ALL Num 8 X552F. 3. FO03: B16. Drug allergies?

13 HOR_ABN Num 8 X552F. 3. FO03: B17. Hormonal abnormalities?

14 MUS_BON Num 8 X552F. 3. FO03: B18. Muscle or bone disease?

15 GEN_URI Num 8 X552F. 3. FO03: B19. Genital or urinary disease?

16 SKI_DIS Num 8 X552F. 3. FO03: B20. Skin Disease or abnormality?

17 EYE_DIS Num 8 X552F. 3. FO03: B21. Any eye disease or abnormality?

18 EAR_NOSE Num 8 X552F. 3. FO03: B22. Ear, nose or throat disease or abnormality?

19 CHOL_TRE Num 8 X552F. 3. FO03: B23. High cholesterol or high triglycerides

20 CHOLES_MED Num 8 X552F. 3. FO03: B23b. High cholesterol or high triglycerides medication?

21 HYSTERECTOMY Num 8 X553F. 3. FO03: B29. Is the patient or patient's partner unable to have children?

22 MAJ_DEP Num 8 X553F. 3. FO03: B33. Major Depression that was diagnosed and required treatment?

23 MAJ_DEP_HOS Num 8 X553F. 3. FO03: B33a. Was he/she hospitalized as a result of the depression?

24 OTH_COND Num 8 X550F. 3. FO03: D1. Are you aware of any significant conditions not listed

25 EXCLU_CRIT Num 8 X550F. 3. FO03: F1. Were any exclusion criteria in section B marked Yes?

26 DEP_RX_MEDS Num 8 X555F. 3. FO03: B35. Any other psychiatric disorder treated with medication?

27 EXPRESS Num 8 X450F. 3. FO03: E1. Is the patient Express (if eligible) or Lead-in?

28 HD_STABLE Num 8 X555F. 3. FO03: B12a. Any significant and stable heart disease?

29 SUICIDE Num 8 X550F. 3. FO03: B36. Has s/he ever attempted suicide?

30 EVENTTYPE_ID Char 4 $4. $4. Study Visit

31 DIABETES Num 8 FO03: B5. Diabetes?


33 VISIT_DAYS Num 8 # days from First Screening Visit to enrollment

34 CDIAG_DAYS Num 8 # days from cancer diagnosis to enrollment

35 CTX_DAYS Num 8 # days end of cancer treatment to enrollment



Num Variable Type Len Format Informat Label 1 IRON Num 8 X582F. 4. FO04: D6. Iron

2 IRON_BIN Num 8 X582F. 4. FO04: D8. Iron Binding capacity

3 SER_FERR Num 8 X582F. 6. FO04: D10. Serum Ferritin

4 CIDI_ADMIN Num 8 X521F. 3. FO04: E3. CIDI administrator

5 CIDI_DIAG Num 8 X550F. 3. FO04: E4. Were there any diagnoses by the CIDI program?

6 CIDI_COUNT Num 8 X582F. 3. FO04: E5. If Yes, how many?

7 GENE_TESTING Num 8 X550F. 3. FO04: G2. Did patient sign Genetic Testing - Consent for testing

8 GENE_INFO Num 8 X550F. 3. FO04: G3. Did patient sign Genetic Testing - Consent for information

9 ELIGIBLE Num 8 X550F. 3. FO04: H1. Immunology/virology ancillary study

10 IMMUN_CONSNT Num 8 X550F. 3. FO04: H1a. Did the patient sign a consent to participate in this study?

11 LIVER_FUNC Num 8 X550F. 3. FO04: H2. Quantitative Liver Function Testing Ancillary Study

12 QUANT_CONSNT Num 8 X550F. 3. FO04: H2a. Did the patient sign a consent to participate in this study

13 COGNITIVE Num 8 X550F. 3. FO04: H3. Cognitive Effects Ancillary Study

14 COG_CONSNT Num 8 X550F. 3. FO04: H3a. Did the patient sign a consent to participate in this study

15 ANA_RES Num 8 X506F. 3. FO04: D12. ANA result

16 CERULOPL Num 8 X550F. 3. FO04: D18. Ceruloplasmin

17 EVENTTYPE_ID Char 4 $4. $4. EVENTTYPE_ID


19 SCREEN_DAYS Num 8 Screen - # of days prior to enrollment

20 IRON_DAYS Num 8 Iron test # of days prior to enrollment

21 IRON_BI_DAYS Num 8 Iron binding capacity # of days prior to enrollment

22 SER_FER_DAYS Num 8 Serum Ferritin # of days prior to enrollment

23 ANA_DAYS Num 8 ANA test # of days prior to enrollment




2 JAUND Num 8 X550F. 3. F06B2a. Tested symptoms

3 OTH_ILL Num 8 X550F. 3. F06B2b. Tested other illness

4 BLOOD_DON Num 8 X550F. 3. F06B2c. Tested blood donor

5 KNOWN_EXP Num 8 X550F. 3. F06B2d. Tested known exposure

6 EVAL_INS Num 8 X550F. 3. F06B2e. Tested insurance evluation

7 DRUG_INJ Num 8 X550F. 3. F06B2f. Tested history inj drug use

8 TRANSFUSION Num 8 X550F. 3. F06B2g. Tested history transfusion

9 PRIOR_DIAG Num 8 X550F. 3. F06B2h. Tested prior diagnosis

10 OTH_REAS Num 8 X550F. 3. F06B2j. Tested other reason

11 TRANS_REC Num 8 X550F. 3. F06B3. Ever received a transfusion

12 HUM_BLOOD Num 8 X550F. 3. F06B4. Ever exposed to human blood job

13 NEEDLE_STICK Num 8 X550F. 3. F06B5. Ever experience needlestick

14 NEEDLE_COUNT Num 8 NEEDLEF. 3. F06B5a. Number times needlestick

15 TATTOO Num 8 X550F. 3. F06B6. Ever tattoed

16 PIERCE Num 8 X550F. 3. F06B7. Ever had body piercing, not ears

17 REC_DRUGS Num 8 X550F. 3. F06B8. Ever used needles recr drugs

18 REC_DRUG_COU Num 8 X570F. 3. F06B8c. Number times injected drugs

19 COCAINE Num 8 X550F. 3. F06B9. Ever snorted cocaine

20 COC_COUNT Num 8 X570F. 3. F06B9c. Number times snorted cocaine

21 MEDICAL_CON Num 8 X550F. 3. F06D1/C1. MD Infected HCV medical care

22 MED_CONF Num 8 X513F. 3. F06D2/C2. MD Confident inf Medical Care

23 EARLY_CONF Num 8 X513F. 3. F06D5/C4. MD confident early year correct

24 YEAR_RANGE Num 8 X582F. 3. F06D6/C5. MD give range if not confident?

25 RANGE_CONF Num 8 X513F. 3. F06D8/C7. MD confident range

26 PRIOR_INT Num 8 X550F. 3. F06E1/D1. Prior treatments interferon

27 TRANS_COUNT Char 2 F06B3a. Number times transfused

28 INT_COURSES Char 2 F06E2/D2. Number prior interferon

29 TATTOO_COUNT Char 2 F06B6a. Number times tattooed


31 fm06_days Num 8 FO06: A4. Visit Date - days from enrollment

32 tran_yrp1 Num 8 F06B3b. Yrs before enrolllent - transfusion 1

33 tran_yrp2 Num 8 F06B3c. Yrs before enrollment - transfusion 2

34 tran_yrp3 Num 8 F06B3d. Yrs before enrollment - transfusion 3

35 tran_yrp4 Num 8 F06B3e. Yrs before enrollment - transfusion 4

36 hum_blood_yp1 Num 8 F06B4a. Yrs before enrollment - human blood 1


Num Variable Type Len Format Informat Label 37 hum_blood_yp2 Num 8 F06B4b. Yrs before enrollment - human blood 2

38 needle_yrp1 Num 8 F06B5b. Yrs before enrollment - needlestick 1

39 needle_yrp2 Num 8 F06B5c. Yrs before enrollment - needlestick 2

40 needle_yrp3 Num 8 F06B5d. Yrs before enrollment - needlestick 3

41 needle_yrp4 Num 8 F06B5e. Yrs before enrollment - needlestick 4

42 tattoo_yrp1 Num 8 F06B6b. Yrs before enrollment - tattoo 1

43 tattoo_yrp2 Num 8 F06B6c. Yrs before enrollment - tattoo 2

44 tattoo_yrp3 Num 8 F06B6d. Yrs before enrollment - tattoo 3

45 tattoo_yrp4 Num 8 F06B6e. Yrs before enrollment - tattoo 4

46 pierce_yrp1 Num 8 F06B7b. Yrs before enrollment - pierce 1

47 pierce_yrp2 Num 8 F06B7c. Yrs before enrollment - pierce 2

48 pierce_yrp3 Num 8 F06B7d. Yrs before enrollment - pierce 3

49 pierce_yrp4 Num 8 F06B7e. Yrs before enrollment - pierce 4

50 rec_drug_yrp1 Num 8 F06B8a. Yrs before enrollment - first injected drugs

51 rec_drug_yrp2 Num 8 F06B8b. Yrs before enrollment - last injected drugs

52 coc_yrp1 Num 8 F06B9a. Yrs before enrollment - first snorted coke

53 coc_yrp2 Num 8 F06B9b. Yrs before enrollment - last snorted coke

54 yrp_inf_pt Num 8 F06B10. Yrs before enrollment - Pt estimated infected

55 yrp_inf_md Num 8 F06D4/C3. Yrs before enrollment - MD est infected

56 range_yrp1 Num 8 F06D7a/C6a. Yrs before enrollment - MD est range earliest infected

57 range_yrp2 Num 8 F06D7b/C6b. Yrs before enrollment - MD est range latest infected

58 pos_yp Num 8 F06B1. Yrs before enrollment - first tested pos

59 prior_yp Num 8 F06B2i. Yrs before enrollment - prior diagnosis


Data Set Name: form007_012_meds_new.sas7bdat

Num Variable Type Len Format Informat Label 1 MEDTYPE Char 12 $CHAR12. $11. Type of medication Rx/OTC/Herbal

2 MEDNAME Char 40 $40. $40. Medication name

3 MCODE Char 10 $10. $10. Medication code

4 START_VISIT Char 3 $3. $3. Medication start visit

5 STOP_VISIT Char 3 $3. $3. Medication stop visit


7 STOP_DAYS Num 8 Stop Date - days since enrollment

8 START_DAYS Num 8 Start Date - days since enrollment

9 MCODE2 Char 10 Corrected Medication Code

10 LAST_F10_VNUM Char 3 $3. $3. Form 10 - last visit number

11 last_f10_days Num 8 Form 10 - last date - days since enrollment



Data Set Name: form007_everherb.sas7bdat

Num Variable Type Len Format Informat Label 1 EVERHERBNAME Char 40 $40. $40. FO07: C2a. Herbal Medication name

2 EVERHERBCODE Char 10 $10. $10. FO07: C2b. Herbal medication code

3 EVERHERBYEAR Num 8 X401F. 3. FO07: C2c. Number of years used this herbal once a week

4 EVERHERBMON Num 8 X401F. 3. FO07: C2d. Number of months used this herbal medication once a week




Num Variable Type Len Format Informat Label 1 IRON Num 8 X582F. 4. FO94: D6. Iron

2 IRON_BIN Num 8 X582F. 4. FO94: D8. Iron Binding Capacity

3 SER_FERR Num 8 X582F. 6. FO94: D10. Serum Ferritin

4 ANA_RES Num 8 X506F. 3. FO94: D12. ANA result

5 CERULOPL Num 8 X550F. 3. FO94: D18. Ceruloplasmin

6 A_1_ANTITRYP Num 8 X486F. 3. FO94: D19. Alpha-1 antitrypsin

7 CIDI_ADMIN Num 8 X521F. 3. FO94: E3. CIDI administrator

8 CIDI_DIAG Num 8 X550F. 3. FO94: E4. Were there any diagnoses by the CIDI program?

9 CIDI_COUNT Num 8 X582F. 3. FO94: E5. If Yes, how many?

10 GENE_TESTING Num 8 X550F. 3. FO94: G2. Did patient sign Genetic Testing - Consent for testing

11 GENE_INFO Num 8 X550F. 3. FO94: G3. Did patient sign Genetic Testing - Consent for information

12 LIVER_FUNC Num 8 X550F. 3. FO94: H1. Quantitative Liver Function Testing Ancillary Study

13 QUANT_CONSNT Num 8 X550F. 3. FO94: H1a. Did the patient sign a consent to participate in this study

14 EVENTTYPE_ID Char 4 $4. $4. Study Visit


16 SCREEN_DAYS Num 8 FO94: A4. Screen date # of days prior to enrollment

17 IRON_DAYS Num 8 FO94: D7. Iron test # of days prior to enrollment

18 IRON_BI_DAYS Num 8 FO94: D9. Iron binding capacity # of days prior to enrollment

19 SER_FER_DAYS Num 8 FO94: D11. Serum Ferritin # of days prior to enrollment

20 ANA_DAYS Num 8 FO94: D13. ANA test # of days prior to enrollment


Data Set Name: haltc_meds_code_atc2.sas7bdat

Num Variable Type Len Format Informat Label 1 MCODE2 Char 10 $7. $7. Corrected Medication Code






7 TYPEC Char 4 Code list used, HERB, OTC, or RX

8 NINGRED Num 8 HALT-C medication code number ingredients











Data Set Name: basedata.sas7bdat - NIDDK Central Repository · 2016. 4. 7. · 5 PATIENT_TYPE Num 8...

Documents

Transcript of Data Set Name: basedata.sas7bdat - NIDDK Central Repository · 2016. 4. 7. · 5 PATIENT_TYPE Num 8...