Info
Dialog
Download

Rating Ratings

Description:

E2805 Treatment Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054B80EC-08C8-3374-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054B80EC-08C8-3374-E044-0003BA3F9857

Keywords:

Clinical Trial

Treatment Form

Kidney Neoplasms

Versions (4)

9/19/12 9/19/12 -
8/8/14 8/8/14 - Martin Dugas
1/8/15 1/8/15 - Martin Dugas
6/8/15 6/8/15 -

Uploaded on:

June 8, 2015

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.

Back to model comments

Itemgroup comments for :

Item comments for :

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

E2805 Treatment Form NCT00326898

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: E2805 Treatment Form
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).

Header

ECOG Protocol Number

ECOG Patient ID

DCI Name

Registration Step

On Treatment Report Period (1 cycle = 6 weeks Choose one X)

Cycle 1 (Cycle 1)

Cycle 2 (Cycle 2)

Cycle 3 (Cycle 3)

Cycle 4 (cycle 4)

5 more items in the detailed view.

Patient demographics

ECOG Protocol Number

ECOG Patient ID

Patient Initials (Last, First)

Participating Group Protocol Number

Institution/Affiliate

Participating Group Patient ID

Data amendment

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

Date data amended (s)

Section I - Vital Status

Vital Status

Alive (Alive)

Dead (Dead)

Date of Last Contact or Death (M D Y)

Primary Cause of Death (if applicable)

Due To Protocol Treatment (Due to protocol treatment)

Due To This Disease (Due to this disease)

Due To Other Cause (Due to other cause)

Unknown (Unknown)

Describe cause of death

Section Ii - Patient Characteristics

Reporting Period Start Date (M D Y)

Reporting Period End Date (M D Y)

ECOG Performance Status (Day 1 of this cycle)

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Agent Name: Sorafenib/placebo

Did the patient complete and return the Patient Pill Calendar this cycle

Yes

Agent Name (Sorafenib/Placebo)

Did the patient return their BAYER bottle this cycle

Yes

Total number of tablets remaining ([hand count required])

Prescribed dose (number of capsules per day - on Day 1 of this cycle)

Expected number of tablets taken ([Prescribed dosenumber of tablets per day *42])

Actual number of capsules taken (by hand count, if available, otherwise by pill diary)

What was the source of the pill count

Patient Pill Diary (Patient pill diary)

Hand Count (Hand count)

Pill Count Not Done (Pill count not done)

If pill count was not done, please explain

Dose Modifications

Agent Name (Sorafenib/Placebo)

Were there any dose modifications or additions/omissions to protocol treatment (this report period)

No (No)

Yes, Planned (Yes, planned)

Yes, Unplanned (Yes, unplanned)

Yes, Both Planned And Unplanned (Yes, both planned and unplanned)

Start Date of Dose Modification (M D Y)

End Date of Dose Modification (M D Y)

Modified Dose (mg)

Reason for therapy modification

Adverse Event (Adverse event)

Agent Discontinued (Agent discontinued)

Other (Other)

Other, specify

Assessment of medication

Agent Name (Sorafenib/Placebo)

Did the patient return their Pfizer bottle this cycle

Yes

Total number capsules remaining (if yes by hand count)

Prescribed dose (number of capsules per day - on Day 1 of this cycle)

Expected number of capsules taken ([Prescribed dose number of capsules per day *28])

Actual number of capsules taken (by hand count, if available, otherwise by pill diary)

What was the source of the pill count

Patient Pill Diary (Patient pill diary)

Hand Count (Hand count)

Pill Count Not Done (Pill count not done)

If pill count was not done, please explain

Dose Modifications

Agent Name (Sorafenib/Placebo)

Were there any dose modifications or additions/omissions to protocol treatment (this report period)

No (No)

Yes, Planned (Yes, planned)

Yes, Unplanned (Yes, unplanned)

Yes, Both Planned And Unplanned (Yes, both planned and unplanned)

Start Date of Dose Modification (M D Y)

End Date of Dose Modification (M D Y)

Modified Dose (mg)

Reason for therapy modification

Adverse Event (Adverse event)

Agent Discontinued (Agent discontinued)

Other (Other)

Other, specify

Section Iv - Blood Pressure

Systolic (mm/Hg)

Diastolic (mm/Hg)

Mark an 'X' if not done

Section V - Last Cycle Of Protocol Therapy

Date of MUGA

Mark an 'X' if not done

Date of assessment (Note: If patient was originally registered to the protocol using an ECHO scan at baseline, an ECHO must be used in lieu of the - MUGA scan for the entirety of the study. In this case, fill in the section below.)

Mark an 'X' if not done

Left Ventricular Ejection Fraction at Rest

LVEF Institutional Lower Limit of Normal

Section Vi - Non-protocol Therapy

Was any non-protocol cancer therapy given during protocol treatment (not previously reported)

Yes

Investigator Signature

Investigator Signature Date

Back to the top of the page

Similar models

Show recommended models

Description:

Link:

Keywords:

Versions (4)

Uploaded on:

DOI:

License :

Model comments :

Itemgroup comments for :

Item comments for :

E2805 Treatment Form NCT00326898

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).

Similar models

Contact

Help