ID

16688

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: Study Drug Administration

Link

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

Keywords

Versions (2)
  1. 7/27/16 7/27/16 -
  2. 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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Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Study Drug Administration
Description

Study Drug Administration

Start Date
Description

Study Drug Administration Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Administered Dose
Description

Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Stop Date
Description

Study Drug Administration Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Dose Modification
Description

Record toxicities on the Adverse Events page.

Data type

integer

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0392360
If other, specify:
Description

Other Dose Modification Reason

Data type

text

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C3840932
Missed Doses
Description

Record the number of missed doses, if any, for the time between the start and stop dates.

Data type

integer

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0750480
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Similar models

Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Drug Administration
Study Drug Administration Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Dose
Item
Administered Dose
float
C0178602 (UMLS CUI [1])
Study Drug Administration Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Dose Modification
integer
C1707811 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Study Drug Dose Modification
Code List
Dose Modification
CL Item
Drug-related Toxicity (AE) (1)
CL Item
Nondrug-related Toxicity (AE) (2)
CL Item
Patient Request  (3)
CL Item
Toxicity lmproved  (4)
CL Item
No Modification (5)
CL Item
Other (specify) (6)
Other Dose Modification Reason
Item
If other, specify:
text
C1707811 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Missed Doses
Item
Missed Doses
integer
C1709043 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
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