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)
  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

Englisch

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

1 Formulare  
Adverse Events
Beschreibung

Adverse Events

Did any Adverse Events occur?
Beschreibung

Adverse Events

Datentyp

boolean

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

Long-Term Follow-Up Adverse Events

Sign/Symptom or Adverse Event
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
Severity (CTC Grade)
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
Start Date: pretreatment
Beschreibung

Adverse Event Start Date

Datentyp

boolean

Alias
UMLS CUI [1]
C2697888
Start Date
Beschreibung

If not pretreatment, please specify start date

Datentyp

date

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

Adverse Event End Date

Datentyp

boolean

Alias
UMLS CUI [1]
C2697886
Stop Date
Beschreibung

If not continuing, please specify stop date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Serious
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
Related to study treatment
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1510821
Action taken
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
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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