ID
16701
Beschrijving
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
Trefwoorden
Versies (1)
- 01-08-16 01-08-16 -
Geüploaded op
1 augustus 2016
DOI
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Licentie
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
Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Beschrijving
Radiology
Beschrijving
Chest/upper abdomen CT scan
Datatype
integer
Alias
- UMLS CUI [1]
- C0202823
- UMLS CUI [2]
- C1627748
Beschrijving
Date chest/upper abdomen CT scan
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202823
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1627748
Beschrijving
If relapse was documented, complete Relapse Report and New Lesion Specification page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0277556
Beschrijving
Radiologic Examination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043299
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Evaluation Method
Datatype
text
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
If relapse was documented, complete Relapse Report and New Lesion Specification page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0277556
Beschrijving
Chest X-ray
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039985
Beschrijving
Chest CT
Datatype
boolean
Alias
- UMLS CUI [1]
- C0202823
Beschrijving
CT of the chest/upper abdomen
Datatype
boolean
Alias
- UMLS CUI [1]
- C0202823
- UMLS CUI [2]
- C1627748
Beschrijving
Long-Term Follow-Up Adverse Events
Beschrijving
Long-Term Follow-Up Adverse Events
Beschrijving
Record only study drug-related events that are ongoing or new.
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
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Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
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C1522577 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,2])
C1627748 (UMLS CUI [2])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
C1627748 (UMLS CUI [2])