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E1105 Adverse Event Form (CTCAE v3) NCT00520975 First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1722503D-5400-666B-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1722503D-5400-666B-E044-0003BA3F9857

Keywords:

Clinical Trial

Adverse event

Breast Neoplasms

Versions (5)

8/26/12 8/26/12 -
1/8/15 1/8/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
7/8/15 7/8/15 -

Uploaded on:

July 8, 2015

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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E1105 Adverse Event Form (CTCAE v3) NCT00520975

English 1

English

Details

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

1 forms

StudyEvent: E1105 Adverse Event Form (CTCAE v3)
1. INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

ECOG clinical trial administrative data

ECOG Protocol Number

ECOG Patient ID

DCI Name

Registration Step

Patient demographics

Patient Initials (Last, First)

ECOG Protocol Number

ECOG Patient ID

Participating Group Protocol Number

Participating Group Patient ID

Institution/Affiliate

Data amendment

Please mark an 'X' if data have been amended.

Date data amended

On Treatment

On Treatment Report Period (since start of treatment)

Cycle 1 (Cycle 1)

Cycle 2 (Cycle 2)

Cycle 3 (Cycle 3)

Cycle 4 (Cycle 4)

8 more items in the detailed view.

On Treatment Report Period (since start of treatment)

Cycle 1 (Cycle 1)

Cycle 2 (Cycle 2)

Cycle 3 (Cycle 3)

Cycle 4 (Cycle 4)

8 more items in the detailed view.

Specify Cycle (specify)

Off Treatment

Off Treatment Report Period (since registration)

3 Months Post Randomization (3 Months Post Randomization)

6 Months Post Randomization (6 Months Post Randomization)

9 Months Post Randomization (9 Months Post Randomization)

12 Months Post Randomization (12 Months Post Randomization)

14 more items in the detailed view.

Adverse event report

Were adverse events assessed during this report period

No (No)

Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)

Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)

CTC Adverse Event Report Begin Date

CTC Adverse Event Report End Date

Blood/bone Marrow - Labs

CTC Adverse Event Term

Anorexia (Anorexia)

Constipation (Constipation)

Cough (Cough)

Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)

18 more items in the detailed view.

CTC Adverse Event Grade (v3.0)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

Was this attributed to investigational protocol treatment

Yes

II. NON-HEMATOLOGIC

CTC Adverse Event Term

Anorexia (Anorexia)

Constipation (Constipation)

Cough (Cough)

Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)

18 more items in the detailed view.

CTC Adverse Event Short Name (Specify site for each event)

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)

Infection With Unknown Anc (Infection with unknown ANC - Select)

CTC Select AE

CTC Adverse Event Grade (v3.0)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

Was this attributed to investigational protocol treatment

Yes

Was this attributed to investigational protocol treatment

Yes

III. NON-HEMATOLOGIC

CTC Adverse Event Term

Anorexia (Anorexia)

Constipation (Constipation)

Cough (Cough)

Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)

18 more items in the detailed view.

CTC Adverse Event Grade (v3.0)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

Was this attributed to investigational protocol treatment

Yes

Other Adverse Events

Other CTC Adverse Event Term not listed

Other, Specify (site or subterm)

CTC Adverse Event Grade (v3.0)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

Was this attributed to investigational protocol treatment

Yes

V. INFECTIONS

CTC Adverse Event Short Name (Specify site for each event)

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)

Infection With Unknown Anc (Infection with unknown ANC - Select)

CTC Select AE

CTC Adverse Event Grade (v3.0)

CTC Adverse Event Attribution Code

Unrelated (unrelated)

Unlikely (unlikely)

Possible (possible)

Probable (probable)

Definite (definite)

Was this attributed to investigational protocol treatment

Yes

Comments

Investigator Signature

Investigator Signature Date

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E1105 Adverse Event Form (CTCAE v3) NCT00520975

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

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