ID
16696
Description
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
Lien
https://clinicaltrials.gov/ct2/show/NCT00373425
Mots-clés
Versions (1)
- 01/08/2016 01/08/2016 -
Téléchargé le
1 août 2016
DOI
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Licence
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
Description
Long-Term Follow-Up Adverse Events
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
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.
Type de données
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Adverse Event Start Date
Type de données
boolean
Alias
- UMLS CUI [1]
- C2697888
Description
If not pretreatment, please specify start date
Type de données
date
Alias
- UMLS CUI [1]
- C2697888
Description
Adverse Event End Date
Type de données
boolean
Alias
- UMLS CUI [1]
- C2697886
Description
If not continuing, please specify stop date
Type de données
date
Alias
- UMLS CUI [1]
- C2697886
Description
If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
A change in relationship should be recorded as a separate event.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1510821
Description
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.
Type de données
integer
Alias
- UMLS CUI [1]
- C2826626