Description:

NCIC MA.32 Serious Adverse Event Folder A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C

Link:
https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C
Keywords:
  1. 8/8/14 8/8/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/17/21 9/17/21 -
Uploaded on:

September 17, 2021

DOI:
To request one please log in.
License :
Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer NCT01101438 Toxicity - NCIC MA.32 Serious Adverse Event Folder - 3027655v1.0

No Instruction available.

  1. StudyEvent: NCIC MA.32 Serious Adverse Event Folder
    1. No Instruction available.
Date Of Event/reporting Period
Temporal relation to SAE to protocol treatment
Event Description
Serious Adverse Events
Grade
Attribution (to Metformin/Placebo)
Action Taken at Time of Adverse Event
AE Outcome
Seriousness Attributed to Adverse Event
Laboratory Tests - Question
Are there any relevant laboratory or physical exam tests to report
Laboratory Test
Diagnostic Test
Nadir/Worst Unit of Measure
Has the patient recovered
Blood Pressure - Question
Are there any relevant blood pressure results to report
Blood Pressure
Has the patient recovered
Other Investigations - Question
Are there any other relevant investigations to report
Other Investigations - Question
Diagnostic Test
Protocol Treatment
Route of Administration
Schedule
Patient rechallenged with agent
Did event reoccur
Prior Systemic Therapy - Question
Has the patient received systemic therapy?
Prior Radiation Therapy - Question
Has the patient received adjuvant RT
Relevant Major Medical Problems - Question
Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
Relevant Major Medical Problems
Relevant major medical problems
Concomitant Medications - Question
Did the participant report taking any concomitant medication
Concomitant Medications
Was this medication used to treat the SAE
Sae Notification Form

Similar models

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial