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:


Versions (4) ▾
  1. 8/8/14
  2. 1/9/15
  3. 1/9/15
  4. 9/17/21
Uploaded on:

September 17, 2021

No DOI assigned. To request one please log in.
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
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
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