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ID
26030
Description
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Hypersensitivity Reaction Record - Repeating form (Scheduled visits)
Keywords
Versions (5)
- 10/4/17 10/4/17 -
- 10/16/17 10/16/17 -
- 10/23/17 10/23/17 -
- 1/1/18 1/1/18 -
- 1/3/18 1/3/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 4, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903
Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903
Similar models
Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Event number
Item
Event number
text
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
Specific Condition Other allergies
Item
10.a Specific Condition
text
CL Item
Past (2)
Item Group
Symptoms associated with this hypersensitivity reaction: 11. Stevens-Johnson syndrome
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Blisters Stevens-Johnson syndrome
Item
Blisters
boolean
Biopsy confirmed Stevens-Johnson syndrome
Item
Biopsy confirmed
boolean
Mucous membrane involvement Stevens-Johnson syndrome
Item
Mucous membrane involvement
boolean
Stevens-Johnson syndrome Symptom start date
Item
Symptom start date
date
Item Group
Symptoms associated with this hypersensitivity reaction: 12. Toxic epidermal necrolysis
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Blisters Toxic epidermal necrolysis
Item
Blisters
boolean
Biopsy confirmed Toxic epidermal necrolysis
Item
Biopsy confirmed
boolean
Mucous membrane involvement Toxic epidermal necrolysis
Item
Mucous membrane involvement
boolean
Symptom start date Toxic epidermal necrolysis
Item
Symptom start date
date
Item Group
Symptoms associated with this hypersensitivity reaction: 13. Urticaria (hives)
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Generalised Urticaria (hives)
Item
Generalised
boolean
Localised Urticaria (hives)
Item
Localised
boolean
Photosensitivity Urticaria (hives)
Item
Photosensitivity
boolean
Other symptoms Urticaria (hives)
Item
Other
boolean
Other symptoms Urticaria (hives) specification
Item
Other, specify
text
Symptom start date Urticaria (hives)
Item
Symptom start date
date
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Angioedema Face
Item
Face (including eyes, lips)
boolean
Angioedema Throat
Item
Throat (including tongue, larynx)
boolean
Angioedema Laryngeal
Item
Laryngeal
boolean
Angioedema Dyspnoea
Item
Dyspnoea
boolean
Angioedema Dysphagia
Item
Dysphagia
boolean
Angioedema Required intubation
Item
Required intubation
boolean
Angioedema Other symptoms
Item
Other
boolean
Angioedema Other symptoms specification
Item
Other, specify
text
Symptom start date Angioedema
Item
Symptom start date
date
Item Group
Symptoms associated with this hypersensitivity reaction: 15. Anaphylactic/Anaphylactoid reaction
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Dyspnoea Anaphylactic/Anaphylactoid reaction
Item
Dyspnoea
boolean
Bronchospasm Anaphylactic/Anaphylactoid reaction
Item
Bronchospasm
boolean
Hypotension Anaphylactic/Anaphylactoid reaction
Item
Hypotension
boolean
Loss of consciousness Anaphylactic/Anaphylactoid reaction
Item
Loss of consciousness
boolean
Persistent gastrointestinal symptoms Anaphylactic/Anaphylactoid reaction
Item
Persistent gastrointestinal symptoms (crampy abdominal pain, vomiting)
boolean
Other symptoms Anaphylactic/Anaphylactoid reaction
Item
Other
boolean
Other symptoms specidication Anaphylactic/Anaphylactoid reaction
Item
Other, specify
text
Symptom start date Anaphylactic/Anaphylactoid reaction
Item
Symptom start date
date
Item Group
Symptoms associated with this hypersensitivity reaction: 16. Other symptoms of hypersensitivity reaction
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Other symptoms of hypersensitivity reaction Rash
Item
Rash
boolean
Other symptoms of hypersensitivity reaction Photosensitivity
Item
Photosensitivity
boolean
Other symptoms of hypersensitivity reaction
Item
Other
boolean
Other symptoms of hypersensitivity reaction specification
Item
Other, specify
text
Start date Other symptoms of hypersensitivity reaction
Item
Symptom start date
date