ID
16701
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00373425
Nyckelord
Versioner (1)
- 2016-08-01 2016-08-01 -
Uppladdad den
1 augusti 2016
DOI
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Licens
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
Beskrivning
Radiology
Beskrivning
Chest/upper abdomen CT scan
Datatyp
integer
Alias
- UMLS CUI [1]
- C0202823
- UMLS CUI [2]
- C1627748
Beskrivning
Date chest/upper abdomen CT scan
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202823
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1627748
Beskrivning
If relapse was documented, complete Relapse Report and New Lesion Specification page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0277556
Beskrivning
Radiologic Examination
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0043299
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Evaluation Method
Datatyp
text
Alias
- UMLS CUI [1]
- C2911685
Beskrivning
If relapse was documented, complete Relapse Report and New Lesion Specification page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0277556
Beskrivning
Chest X-ray
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039985
Beskrivning
Chest CT
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0202823
Beskrivning
CT of the chest/upper abdomen
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0202823
- UMLS CUI [2]
- C1627748
Beskrivning
Long-Term Follow-Up Adverse Events
Beskrivning
Long-Term Follow-Up Adverse Events
Beskrivning
Record only study drug-related events that are ongoing or new.
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Similar models
Long-Term Follow-Up Assessment, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
C0750480 (UMLS CUI [1,2])
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])