ID
16696
Beschreibung
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
Stichworte
Versionen (1)
- 01.08.16 01.08.16 -
Hochgeladen am
1. August 2016
DOI
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Lizenz
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
Beschreibung
Long-Term Follow-Up Adverse Events
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Adverse Event Start Date
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
If not pretreatment, please specify start date
Datentyp
date
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
Adverse Event End Date
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2697886
Beschreibung
If not continuing, please specify stop date
Datentyp
date
Alias
- UMLS CUI [1]
- C2697886
Beschreibung
If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
A change in relationship should be recorded as a separate event.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1510821
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626