ID

16701

Description

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Long-Term Follow-Up Assessment

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Keywords

Versions (1)
  1. 8/1/16 8/1/16 -
Uploaded on

August 1, 2016

DOI

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License

Creative Commons BY 4.0
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Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Long-Term Follow-Up Assessment
Description

Long-Term Follow-Up Assessment

Alias
UMLS CUI-1
C1522577
Follow-up Number
Description

Follow-up Number

Data type

integer

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0750480
Date of Follow-up:
Description

Date attempted to obtain patient status.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1522577
Patient Status
Description

Patient Status

Data type

integer

Alias
UMLS CUI [1]
C3846084
If patient alive: Date last known to be alive
Description

Date last known to be alive

Data type

date

Alias
UMLS CUI [1]
C0805839
If patient alive: Has the patient had a relapse of NSCLC since the last assessment?
Description

If Yes, complete Relapse Report and New Lesion Specification page, if not previously reported.

Data type

boolean

Alias
UMLS CUI [1]
C0277556
If patient alive: Has the patient received new anticancer treatment for NSCLC since the last assessment?
Description

If yes, complete New Anticancer Treatment page, if not previously reported.

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0007131
If lost to follow-up: Date of last patient contact:
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
If lost to follow-up: What attempts were made to follow up on the patient status?
Description

Follow-up attempts

Data type

text

Alias
UMLS CUI [1]
C1302313
If patient deceased: Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
If patient deceased: Primary Cause of Death
Description

Cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
Please specify cause of death:
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
If patient deceased: Was an autopsy performed?
Description

Autopsy

Data type

integer

Alias
UMLS CUI [1]
C0004398
Radiology
Description

Radiology

Was a chest/upper abdomen CT scan performed?
Description

Chest/upper abdomen CT scan

Data type

integer

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C1627748
Date chest/upper abdomen CT scan performed:
Description

Date chest/upper abdomen CT scan

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0202823
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1627748
If Yes, was relapse documented?
Description

If relapse was documented, complete Relapse Report and New Lesion Specification page.

Data type

boolean

Alias
UMLS CUI [1]
C0277556
Was any other radiological disease assessment performed?
Description

Radiologic Examination

Data type

boolean

Alias
UMLS CUI [1]
C0043299
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Specify type of assessment:
Description

Evaluation Method

Data type

text

Alias
UMLS CUI [1]
C2911685
If Yes, was relapse documented?
Description

If relapse was documented, complete Relapse Report and New Lesion Specification page.

Data type

boolean

Alias
UMLS CUI [1]
C0277556
Did the ''Other'' radiological assessment performed include X-Ray imaging of the chest?
Description

Chest X-ray

Data type

boolean

Alias
UMLS CUI [1]
C0039985
Did the ''Other'' radiological assessment performed include CT imaging of the chest?
Description

Chest CT

Data type

boolean

Alias
UMLS CUI [1]
C0202823
Did the ''Other'' radiological assessment performed include CT imaging of the chest/upper abdomen?
Description

CT of the chest/upper abdomen

Data type

boolean

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C1627748
Long-Term Follow-Up Adverse Events
Description

Long-Term Follow-Up Adverse Events

Did any Adverse Events occur?
Description

Record only Study Drug-related events that are ongoing or new? ALL related Serious Adverse Events must be recorded on the Serious Adverse Events Report Form.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Long-Term Follow-Up Adverse Events
Description

Long-Term Follow-Up Adverse Events

Sign/Symptom or Adverse Event
Description

Record only study drug-related events that are ongoing or new.

Data type

text

Alias
UMLS CUI [1]
C0877248
Severity (CTC Grade)
Description

Grade severity (1,2,3,4,5) using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A change in CTC grade should be recorded as a separate event.

Data type

integer

Alias
UMLS CUI [1]
C1710066
Start Date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Stop Date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Serious
Description

If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.

Data type

boolean

Alias
UMLS CUI [1]
C1710056
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Similar models

Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Long-Term Follow-Up Assessment
C1522577 (UMLS CUI-1)
Follow-up Number
Item
Follow-up Number
integer
C1522577 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Date of Follow-up
Item
Date of Follow-up:
date
C0011008 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Item
Patient Status
integer
C3846084 (UMLS CUI [1])
Patient Status
Code List
Patient Status
CL Item
Alive (1)
CL Item
Lost to follow-up (2)
CL Item
Deceased (3)
Date last known to be alive
Item
If patient alive: Date last known to be alive
date
C0805839 (UMLS CUI [1])
Relapse
Item
If patient alive: Has the patient had a relapse of NSCLC since the last assessment?
boolean
C0277556 (UMLS CUI [1])
Anticancer Treatment for NSCLC
Item
If patient alive: Has the patient received new anticancer treatment for NSCLC since the last assessment?
boolean
C0087111 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Date of last contact
Item
If lost to follow-up: Date of last patient contact:
date
C0805839 (UMLS CUI [1])
Follow-up attempts
Item
If lost to follow-up: What attempts were made to follow up on the patient status?
text
C1302313 (UMLS CUI [1])
Date of death
Item
If patient deceased: Date of death
date
C1148348 (UMLS CUI [1])
Item
If patient deceased: Primary Cause of Death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
If patient deceased: Primary Cause of Death
CL Item
NSCLC Relapse (Complete Relapse Report page, if not previously reported) (1)
CL Item
Protocol-related toxicity (specify) (2)
CL Item
lntercurrent illness (specify) (3)
CL Item
Other (specify) (4)
CL Item
Unknown (5)
Cause of Death
Item
Please specify cause of death:
text
C0007465 (UMLS CUI [1])
Item
If patient deceased: Was an autopsy performed?
integer
C0004398 (UMLS CUI [1])
Autopsy
Code List
If patient deceased: Was an autopsy performed?
CL Item
Yes (If Yes, append a copy of the autopsy report) (1)
CL Item
No (2)
Item Group
Radiology
Item
Was a chest/upper abdomen CT scan performed?
integer
C0202823 (UMLS CUI [1])
C1627748 (UMLS CUI [2])
Chest/upper abdomen CT scan
Code List
Was a chest/upper abdomen CT scan performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date chest/upper abdomen CT scan
Item
Date chest/upper abdomen CT scan performed:
date
C0011008 (UMLS CUI [1,1])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
Relapse
Item
If Yes, was relapse documented?
boolean
C0277556 (UMLS CUI [1])
Radiologic Examination
Item
Was any other radiological disease assessment performed?
boolean
C0043299 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Evaluation Method
Item
Specify type of assessment:
text
C2911685 (UMLS CUI [1])
Relapse
Item
If Yes, was relapse documented?
boolean
C0277556 (UMLS CUI [1])
Chest X-ray
Item
Did the ''Other'' radiological assessment performed include X-Ray imaging of the chest?
boolean
C0039985 (UMLS CUI [1])
Chest CT
Item
Did the ''Other'' radiological assessment performed include CT imaging of the chest?
boolean
C0202823 (UMLS CUI [1])
CT of the chest/upper abdomen
Item
Did the ''Other'' radiological assessment performed include CT imaging of the chest/upper abdomen?
boolean
C0202823 (UMLS CUI [1])
C1627748 (UMLS CUI [2])
Item Group
Long-Term Follow-Up Adverse Events
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Item Group
Long-Term Follow-Up Adverse Events
Adverse Events
Item
Sign/Symptom or Adverse Event
text
C0877248 (UMLS CUI [1])
Item
Severity (CTC Grade)
integer
C1710066 (UMLS CUI [1])
Adverse Event Severity
Code List
Severity (CTC Grade)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Adverse Event Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Stop Date
date
C2697886 (UMLS CUI [1])
Seriousness of Adverse Event
Item
Serious
boolean
C1710056 (UMLS CUI [1])
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