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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:

Clinical Trial

Adverse event

Breast Neoplasms

Versions (4)

8/8/14 8/8/14 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/17/21 9/17/21 -

Uploaded on:

September 17, 2021

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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

English 1

English

Details

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1 forms

StudyEvent: NCIC MA.32 Serious Adverse Event Folder
1. No Instruction available.

Date Of Event/reporting Period

Start Date of Primary AE

SAE Reported to Investigator Date

Temporal relation to SAE to protocol treatment

During Protocol Treatment (during protocol treatment)

Within 30 Days After Completion Of Protocol Treatment (within 30 days after completion of protocol treatment)

More Than 30 Days After Completion Of Protocol Treatment (more than 30 days after completion of protocol treatment)

Reporting period at which SAE occurred

Event Description

Serious Adverse Events

CTC Adverse Event Term

Event Onset Time

Event End Time

Grade

Absent Adverse Event (0)

Mild Adverse Event (1)

Moderate Adverse Event (2)

Severe Adverse Event (3)

Life Threatening Adverse Event (4)

Death Related To Adverse Event (5)

Attribution (to Metformin/Placebo)

Definite (Definite)

Possible (Possible)

Probable (Probable)

Unlikely (Unlikely)

Unrelated (Unrelated)

Action Taken at Time of Adverse Event

There Was No Action Taken Based On The Adverse Event (none)

Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)

Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)

Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)

AE Outcome

Recovered Or Resolved Without Sequelae (Recovered/Resolved without Sequelae)

Not Recovered Or Not Resolved (Not recovered/Not resolved)

Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)

Fatal Or Died (Fatal/Died)

Seriousness Attributed to Adverse Event

Not Serious (Not serious)

Death (Death)

Life Threatening (Life threatening)

Hospitalized (Hospitalization, initial or prolonged)

3 more items in the detailed view.

Laboratory Tests - Question

Are there any relevant laboratory or physical exam tests to report

Yes

Laboratory Test

Diagnostic Test

Activated Partial Thromboplastin Time (Activated partial thromboplastin time (APTT))

Albumin (Albumin - blood)

Alkaline Phosphatase (Alkaline phosphatase NOS)

Alkaline Phosphatase (Alkaline phosphates NOS)

45 more items in the detailed view.

Specify

Nadir/Worst Value

Nadir/Worst Date (at Time of SAE)

Nadir/Worst Unit of Measure

Percent (%)

1000 Per Cubic Millimiter (1000/mm3)

1000 Per Microliter (1000/uL)

Cubic Centimeters Per Minute (cc/min)

23 more items in the detailed view.

LLN

ULN

Has the patient recovered

Yes

Recovery or Latest Value

Date of Recovery or Death

Name of Laboratory (where tests were completed)

Blood Pressure - Question

Are there any relevant blood pressure results to report

Yes

Blood Pressure