ID
16696
Descrição
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
Palavras-chave
Versões (1)
- 01/08/2016 01/08/2016 -
Transferido a
1 de agosto de 2016
DOI
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Licença
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
Descrição
Long-Term Follow-Up Adverse Events
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0877248
Descrição
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.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1710066
Descrição
Adverse Event Start Date
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2697888
Descrição
If not pretreatment, please specify start date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2697888
Descrição
Adverse Event End Date
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2697886
Descrição
If not continuing, please specify stop date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2697886
Descrição
If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1710056
Descrição
A change in relationship should be recorded as a separate event.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1510821
Descrição
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.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C2826626