ID
16696
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: Adverse Events
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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Adverse Events, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
Adverse Events, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Beschrijving
Long-Term Follow-Up Adverse Events
Beschrijving
Record ALL Baseline Signs and Symptoms that occur within 24 hours prior to First Dosing. ALL Adverse Events, including Serious Adverse Events should be recorded. In addition, ALL Serious Adverse Events must be recorded on the Serious Adverse Event Report Form.
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
boolean
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
If not pretreatment, please specify start date
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Adverse Event End Date
Datatype
boolean
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
If not continuing, please specify stop 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
Beschrijving
A change in relationship should be recorded as a separate event.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1510821
Beschrijving
If event caused drug discontinuation, complete the Withdrawal From Study Due To Nonserious Adverse Event Form and fax to the appropriate number on the CRF General lnstructions page.
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626