Bashi Ratterree, RN, BSN, CCRPNurse Coordinator, CHM

OHSU Knight Cancer Institute

Mail code: UHN73C 503-494-9982

ratterre@ohsu.edu

A Phase II Trial of the Safety and Efficacy of Abc-001 for the Treatment of

CoordinatorStressitis

2 yr trial Abc-001 50 mg tablet daily PO

30 subjectsAge > 18 years

Dx: occupation in research

Adverse Events Reporting Exercise

Investigator’s Brochure Drug: Abc-001

Serious reactions

• Death• Respiratory distress• Severe neutropenia• Hepatitis• Excessive bleeding

Common side effects

• Nausea• Vomiting• Diarrhea• Abdominal pain • Abnormal LFT’s• Rash • Low K+ • Elevated

QTc• Headaches

History for Subject 507

• 41 year old female otherwise in good general health

• Diagnosis of occupation in research• Medical hx: asthma, allergies• Complains of intermittent, mild headaches • No known drug allergies• Meds: Zyrtec, multi-vitamin, ibuprofen

Physical for Subject 507

• Alert, oriented, NAD• Normal physical exam• BP 110/70, HR 76

Exercise Questions to Keep in Mind

• Is there an adverse event?• What is the severity?• What is the relationship to study

drug? • Is it a serious adverse event?• Is it an unanticipated problem?• Does it need to be reported? • To whom do you report?

Serious Adverse Events

• Death• Life-Threatening• Hospitalization (initial or prolonged)• Disability• Congenital Anomaly• Requires Intervention to Prevent Permanent

Impairment or Damage• Results in psychological or emotional harm

requiring treatment• Results in a significant medical incident

Unanticipated Problems –Remember: ‘Must fit all’

1. On Protocol2. SAE3. Unanticipated 4. Related or Possibly Related

Category 1

1. On Protocol2. Anticipated AE or SAE3. Related or Possibly Related4. Occurring at a higher frequency or severity

Category 2

1. Unanticipated AE or SAE2. Related or Possibly Related3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process

Category 3

1. Unanticipated2. ‘Other’ events3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred.

Category 4

If event does not fit, it is not reportable.

Progress Note

1/3/10 Subject 507 in for study visit. Reports feeling her

usual self. Takes study drug regularly. No side effects reported. No change in concomitant medications.

Subject Diary

1/10/10 Anxiety attack had to miss work. Felt nervous

all day.

1/12/10 Feeling better. Back at work.

Example of documentation of AE & Con Med

AE# AE Start

dateStop date

SAE

UP Grade Attribution DLT Action Therapy Outcom

e

1 Anxiety attack 1/10/10 1/12/10 N N 2 Unlikely No None Lorazepam Recovere

d

#Start_____

StopAgent or Procedure

Dose______

Route

Schedule_______________

Reason

If applicable,

AE #

1Jan/05

Lorazepam1 mg Q 4-6 hrs PRN

1ongoing PO Anxiety

Progress Note

1/22/10 Subject 507 in for study visit. Reports nausea

lasting 2 hours on 1/18/10.

1/27/10 Reports fractured ankle from falling off a horse.

Outpatient surgical repair with excessive bleeding that

required overnight hospitalization. Study drug held for 2

weeks. Vicodin added to concomitant medications.

Progress Note

Progress Note

2/2/10 Subject 507 in for study visit. Reports recoveringfrom ankle fracture. Complains of increased headaches. Doubled her use of ibuprofen, continues pain medication and no change in other meds. Headaches are so severe, subject could not go to work.

Vital signs: BP 170/95, HR 90

Progress Note

2/15/10 Subject 507 in for study visit. Reports cold

symptoms of runny nose and non-productive cough. Took

cold remedies for 2 days. Does not recall the medication

names, doses or dates taken.

Plan: Review the importance of keeping track of dates and

any concomitant medications while participating in a study.

• 2/20/10 Someone broke into your car and stole a few items … including the laptop on which you keep data for this study.

Progress Note

Progress Note

3/3/10 Subject 507 in for study visit. Reports stomach

ache about 30 minutes after taking study drug. Lasts 1

hour, does not require medication or interfere with her

usual activity.

Exercise Questions

• Is there an adverse event?• What is the severity?• What is the relationship to study drug? • Is it a serious adverse event?• Is it an unanticipated problem?• Does it need to be reported? • To whom do you report?

Progress Note

3/15/10 Subject 507 in for study visit. Reports rapid

onset of intermittent blurred vision beginning 3/9/10

and lasting 3 days. Reports no other problems.Continues study drug and no change in

concomitantmedications.

Progress Note

4/15/10 Subject reports having horrible nightmares. According to her spouse, she is sleep walking and has become a danger to herself.

Subject is admitted to the sleep unit for overnight observation.

Questions? Comments?