ID
16696
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: Adverse Events
Länk
https://clinicaltrials.gov/ct2/show/NCT00373425
Nyckelord
Versioner (1)
- 2016-08-01 2016-08-01 -
Uppladdad den
1 augusti 2016
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
Beskrivning
Long-Term Follow-Up Adverse Events
Beskrivning
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.
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
boolean
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
If not pretreatment, please specify start date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Adverse Event End Date
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
If not continuing, please specify stop 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
Beskrivning
A change in relationship should be recorded as a separate event.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1510821
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626