ID

16624

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 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

July 27, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Test A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

English

Study Drug Administration A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

1 forms  
Header
Description

Header

Site Number
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
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 (Record toxicities on the Adverse Events page.)
Description

Study Drug Dose Modification

Data type

integer

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

Study Drug Dose Modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Missed Doses (Record the number of missed doses, if any, for the time between the start and stop dates.)
Description

Missed Doses

Data type

integer

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

Study Drug Administration A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Site number
Item
Site Number
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
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 (Record toxicities on the Adverse Events page.)
integer
C1707811 (UMLS CUI [1])
Study Drug Dose Modification
Code List
Dose Modification (Record toxicities on the Adverse Events page.)
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)
Study Drug Dose Modification
Item
If other, specify:
text
C1707811 (UMLS CUI [1])
Missed Doses
Item
Missed Doses (Record the number of missed doses, if any, for the time between the start and stop dates.)
integer
C1709043 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
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