ID

16701

Beschreibung

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

Stichworte

Versionen (1)
  1. 01.08.16 01.08.16 -
Hochgeladen am

1. August 2016

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Long-Term Follow-Up Assessment
Beschreibung

Long-Term Follow-Up Assessment

Alias
UMLS CUI-1
C1522577
Follow-up Number
Beschreibung

Follow-up Number

Datentyp

integer

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

Date attempted to obtain patient status.

Datentyp

date

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

Patient Status

Datentyp

integer

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

Date last known to be alive

Datentyp

date

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

Date of last contact

Datentyp

date

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

Follow-up attempts

Datentyp

text

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

Date of death

Datentyp

date

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

Cause of death

Datentyp

integer

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

Cause of Death

Datentyp

text

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

Autopsy

Datentyp

integer

Alias
UMLS CUI [1]
C0004398
Radiology
Beschreibung

Radiology

Was a chest/upper abdomen CT scan performed?
Beschreibung

Chest/upper abdomen CT scan

Datentyp

integer

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

Date chest/upper abdomen CT scan

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

Radiologic Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0043299
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

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

Evaluation Method

Datentyp

text

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

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

Datentyp

boolean

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

Chest X-ray

Datentyp

boolean

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

Chest CT

Datentyp

boolean

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

CT of the chest/upper abdomen

Datentyp

boolean

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

Long-Term Follow-Up Adverse Events

Did any Adverse Events occur?
Beschreibung

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.

Datentyp

boolean

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

Long-Term Follow-Up Adverse Events

Sign/Symptom or Adverse Event
Beschreibung

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

Datentyp

text

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

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.

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Start Date
Beschreibung

Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Stop Date
Beschreibung

Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Serious
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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