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:

  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 -
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September 17, 2021

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01101438 Toxicity - NCIC MA.32 Serious Adverse Event Folder - 3027655v1.0

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  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

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