ID

17655

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: Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

Link

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

Keywords

Versions (2)
  1. 8/1/16 8/1/16 -
  2. 9/27/16 9/27/16 -
Uploaded on

September 27, 2016

DOI

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License

Creative Commons BY 4.0
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Prevention and Treatment of Skin, Hair and Nail Reactions, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Prevention and Treatment of Skin, Hair and Nail Reactions
Description

Prevention and Treatment of Skin, Hair and Nail Reactions

Interventions used to prevent and treat skin, hair and nail reactions: None
Description

Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221743
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0018500
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0234909
Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
Description

Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

Intervention (Use generic name when possible)
Description

Record all topical creams, gels, oral or IV medications, and/or other interventions used to prevent and treat skin, hair and nail reactions (includes rash, skin fissures, nail and hair changes, etc) due to study drug administration. Moisturizers and sunscreens used to prevent and treat skin reactions should be recorded on the Moisturizers and Sunscreens CRF page.

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221743
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0018500
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0234909
Prophylaxis
Description

Indication Prophylaxis

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0199176
Route
Description

Drug Administration Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
If other, please specify
Description

Drug Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Specific Indication should be reported on the Adverse Event (Including Baseline Signs/Symptoms) CRF page, unless the intervention was given as a prophylaxis.

Data type

integer

Alias
UMLS CUI [1]
C3146298
If other, please specify
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Date Started
Description

Date Started

Data type

date

Alias
UMLS CUI [1]
C3173309
Date Stopped
Description

Date Stopped

Data type

date

Alias
UMLS CUI [1]
C1531784
Date stopped: Post treatment
Description

Date Stopped

Data type

boolean

Alias
UMLS CUI [1]
C1531784
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Similar models

Prevention and Treatment of Skin, Hair and Nail Reactions Due to 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
Prevention and Treatment of Skin, Hair and Nail Reactions
Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
Item
Interventions used to prevent and treat skin, hair and nail reactions: None
boolean
C0087111 (UMLS CUI [1,1])
C0221743 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0018500 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0234909 (UMLS CUI [3,2])
Item Group
Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
Intervention
Item
Intervention (Use generic name when possible)
text
C0087111 (UMLS CUI [1,1])
C0221743 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0018500 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0234909 (UMLS CUI [3,2])
Indication Prophylaxis
Item
Prophylaxis
boolean
C3146298 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
Item
Route
integer
C0013153 (UMLS CUI [1])
Type
Code List
Route
CL Item
Topical (1)
CL Item
Oral (2)
CL Item
IV (3)
CL Item
Procedure (4)
CL Item
Other (specify) (5)
Drug Administration Route
Item
If other, please specify
text
C0013153 (UMLS CUI [1])
Item
Indication
integer
C3146298 (UMLS CUI [1])
Indication
Code List
Indication
CL Item
Skin Reaction (1)
CL Item
Hair Changes (2)
CL Item
Nail Changes (3)
CL Item
Other (specify) (4)
Indication
Item
If other, please specify
text
C3146298 (UMLS CUI [1])
Date Started
Item
Date Started
date
C3173309 (UMLS CUI [1])
Date Stopped
Item
Date Stopped
date
C1531784 (UMLS CUI [1])
Date Stopped
Item
Date stopped: Post treatment
boolean
C1531784 (UMLS CUI [1])
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