9090-08 SAE Reporting Judy Breed, BA, RN June, 2011 CONFIDENTIAL.
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Transcript of 9090-08 SAE Reporting Judy Breed, BA, RN June, 2011 CONFIDENTIAL.
9090-08 SAE Reporting
Judy Breed, BA, RNJune, 2011
CONFIDENTIAL
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 2
Why Drug Safety?
• Patient protection
• Safe drug development
• Corporate protection
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 3
What?
Adverse events
Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 4
AEs What ?
Examples
• Exacerbation of a pre-existing illness
• Increase in the frequency or intensity of a pre-existing or intermittent event
• New illness or condition
• Pregnancy
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 5
When to Report Adverse Events
Immediately following Informed Consent signing until 30 days after the last dose of study drug
.…unless a new anti-cancer treatment is initiated after study termination
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 6
AEs and Serious AEs
Severe vs Serious
Severity = Intensity of an event
Pain 9 on a 0-10 scale really hurts, but is not Serious unless……
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 7
Serious Adverse Event Definition
Fatal
Life-threatening
Disabling or incapacitating
Hospitalization, new or prolonged
Congenital anomaly
Other medically important events
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 8
SAE Definition cont’d
Fatal Event– The event results in death
– Death is not the event, it is the outcome of the event
Disabling or incapacitating– Substantially disrupts ADLs
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 9
SAE Definition cont’d
Hospitalization
Admission to hospital for diagnosis and/or treatment of an event or condition
Event term = Diagnosis or major symptom(s)
Event term ≠ a Procedure
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 10
SAE Definition cont’d
Complication during Hospitalization?– Is an adverse event (AE) unless
– Complication prolongs hospitalization = SAE
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 11
SAE Definition cont’d
Congenital Anomaly or Birth Defect
– Occurring in the offspring of a female or male subject who received study drug
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 12
SAE Definition cont’d
Medically Important Event
– Event does not meet any other criterion for Serious, but
– May jeopardize the subject, may require intervention to prevent the one of the other outcomes (death, life-threatening, hospitalization or congenital anomaly or birth defect)
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 13
Hospitalizations for the sole purpose of study drug administration
Hospitalization for elective procedure planned/scheduled prior to study
Hospitalizations for the verbatim term Disease Progression
Death as the event (Death = an outcome)
What’s NOT an SAE
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 14
What NOT to Report
Disease Progression – it is a study endpoint and is captured elsewhere
Unless- E.g., initially hospitalized for Severe Abdominal Pain for pain management and hydration and discovered to have disease progression that is clearly resulting in the abdominal pain
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 15
SAEs: When to Submit
Within 24 hours of learning of the event
– If a specific subject and event that meets the definition of serious is discussed with any Synta or Ergomed employee, the reporting clock has been started!
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 16
Expedited SAE Reports
Serious
Unexpected
Related
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 17
SAE Reporting to Regulators
7- Day Report– Serious
– Unexpected
– Life-threatening or fatal
– Date Synta learns of the event = Day 0
– Regulatory Clock is in calendar, not business, days
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 18
SAE Reporting to Regulators
15-Day Report– Serious
– Unexpected
– Not life-threatening or fatal
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 19
SAE Reporting to Regulators
Expedited Reports (7 and 15-Day reports) may be downgraded to just Serious
Serious Adverse Events may be upgraded to 7 or 15-Day Reports
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 20
SAE Reporting
Tools of the Trade
SAE Report FormPregnancy Report FormsSAE Completion Guidelines
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 21
SAE Form
Drug Safety Documents
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 22
SAE Completion Guidelines
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 23
Do Report
Pregnancy Form
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 24
Drug Safety Contact Information
Synta Fax for Reporting + 1 866 558 2230Drug Safety Phone (hot line) + 1 866 255 0025
Judy Breed, Direct + 1 781 541 7201
Ergomed Fax for Reporting +48 12 622 44 60Drug Safety Phone +48 12 622 44 69
email [email protected]
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 25
Overview of SAE Report Form Sections
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 26
0123 8012/FirstMiddleLast
Weight required for dosing
Height required for dosing
DOB must be a full date
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 27
SAE Report Forms
The Trouble Spots
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Trouble….the Hotspots
Relationship to ganetespib and docetaxl
Medical History- Chronic, controlled conditions
Submission of blank pages
Prior history of the event
Ongoing vs Resolved at time of death
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 29
150mg/m2, IV weekly X 3/cycle
Dose reduced to 125mg/m2 12DEC2010, 300mg IV weekly X 3/cycle
Hypersensitivity reaction? Complete Dechallenge & Rechallenge questions for sure!!
ganetespib
Stop date is date of final dose. If dosing continues, leave blank
Date of last dose prior to SAE is the most recent dose
Relationship- must be included on the Initial report!
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 30
docetaxel
Lot #: Capture in real time! Include in source docs
Hypersensitivity reaction? Complete Dechallenge & Rechallenge questions for sure!!
75mg/m2 IV on Day 1 of 3 week cycle
125mg IV on Day 1 of 3 week cycle
Complete in same way as Section E for ganetespib
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 31
Submit printout of Medical History eCRF!
Chronic, controlled conditions are Continuing
Partial dates are OK: e.g., ??-???-1999
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 32
Helpful
Not so helpful
Both of these submitted pages are part of the permanent safety record!
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 33
Diagnosis If no Dx, major symptoms
01238012/FirstMiddleLast
9090-08
Ever?
Death As a result of this event
Death = Outcome?, thenSeverity = Death/Grade 5 and Serious = Death
Use Other if SAE predates study drug administration
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 34
Admission note, consultation notes, discharge notes etc may be attached.Discharge notes- please read before sending! Not always informative
Death certificate and autopsy not required by protocol. Send if available.
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 35
Indication should correspond to Medical History Information
Medications within preceding 30 days
No SAE treatment meds here!
Trade or generic name unless combination drug, e.g., Tylenol PM®
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 36
Treatment meds used, but don’t want to write in here? Check [X] See CRF or source documents attached and submit them instead!
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 37
Submit printout of labs with reference ranges
Write legibly please
Email address- ALWAYS provide
Always important and even more so if 7 or 15 day report!
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 38
SAE Follow-up from Study Sites
Follow-up SAE Reports
Must be submitted when:– Event term changes
– Relationship to study drug changes
– Another concomitant event meeting SAE criteria occurs
– Event resolves or stabilizes
– Any new information or reports are received
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 39
SAE Follow-up from Synta or Ergomed Drug Safety
Format of Safety Request for Information– Email
– Will identify if event meets 7 or 15 Day Reporting Requirements and due date for additional key information and Regulatory Reporting
Requests for– Missing data
– Clarification of existing data or terms
– Additional information
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 40
SAE Follow-up from Study Sites to Drug Safety Queries
Format of Site Response– Amended SAE Report Form
– Source documents e.g., Discharge summary
– Autopsy report, if available
RDC Requirement– Update RDC with new or revised SAE data
Data Management may also have queries on AS/SAE data that will require amendment of a previously Reported SAE
CONFIDENTIAL© 2011 Synta Pharmaceuticals Corp. 41
Well documented, accurate reports
The complete picture
Translations of relevant non-English source documents
No abbreviations or acronyms
No missing data or inconsistencies
Prompt reply to all Follow-up questions
An SAE report which seems insignificant at the time of reporting, could result in identification of an important safety signal!
What do we really want?