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

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Keywords

Versions (1)
  1. 8/1/16 8/1/16 -
Uploaded on

August 1, 2016

DOI

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License

Creative Commons BY 4.0
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Adverse Events, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Adverse Events, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Adverse Events
Description

Adverse Events

Did any Adverse Events occur?
Description

Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Long-Term Follow-Up Adverse Events
Description

Long-Term Follow-Up Adverse Events

Sign/Symptom or Adverse Event
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.

Data type

text

Alias
UMLS CUI [1]
C0877248
Severity (CTC Grade)
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.

Data type

integer

Alias
UMLS CUI [1]
C1710066
Start Date: pretreatment
Description

Adverse Event Start Date

Data type

boolean

Alias
UMLS CUI [1]
C2697888
Start Date
Description

If not pretreatment, please specify start date

Data type

date

Alias
UMLS CUI [1]
C2697888
Stop Date: continuing
Description

Adverse Event End Date

Data type

boolean

Alias
UMLS CUI [1]
C2697886
Stop Date
Description

If not continuing, please specify stop date

Data type

date

Alias
UMLS CUI [1]
C2697886
Serious
Description

If event is serious, complete the SERIOUS ADVERSE EVENT FORM and fax to the appropriate number on the CRF General lnstructions page.

Data type

boolean

Alias
UMLS CUI [1]
C1710056
Related to study treatment
Description

A change in relationship should be recorded as a separate event.

Data type

boolean

Alias
UMLS CUI [1]
C1510821
Action taken
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.

Data type

integer

Alias
UMLS CUI [1]
C2826626
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Similar models

Adverse Events, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Events
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Item Group
Long-Term Follow-Up Adverse Events
Adverse Events
Item
Sign/Symptom or Adverse Event
text
C0877248 (UMLS CUI [1])
Item
Severity (CTC Grade)
integer
C1710066 (UMLS CUI [1])
Adverse Event Severity
Code List
Severity (CTC Grade)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Adverse Event Start Date
Item
Start Date: pretreatment
boolean
C2697888 (UMLS CUI [1])
Adverse Event Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Stop Date: continuing
boolean
C2697886 (UMLS CUI [1])
Adverse Event End Date
Item
Stop Date
date
C2697886 (UMLS CUI [1])
Seriousness of Adverse Event
Item
Serious
boolean
C1710056 (UMLS CUI [1])
Relation to study treatment
Item
Related to study treatment
boolean
C1510821 (UMLS CUI [1])
Item
Action taken
integer
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action taken
CL Item
None (1)
CL Item
Dose Reduced (2)
CL Item
Dose Temporarily Withheld (3)
CL Item
Dose Temporarily Withheld and Reduced (4)
CL Item
Drug Discontinued (5)
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