ID
28310
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
January 3, 2018
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
Description
Past medical conditions: 2. Food allergies
Description
Past medical conditions: 3. Hymenoptera sting allergy
Description
Anaphylaxis Hymenoptera sting allergy
Data type
integer
Alias
- UMLS CUI [1]
- C0002792
Description
Angioedema Hymenoptera sting allergy
Data type
integer
Alias
- UMLS CUI [1]
- C0002994
Description
Urticaria Hymenoptera sting allergy
Data type
integer
Alias
- UMLS CUI [1]
- C0042109
Description
Past medical conditions: 4. Latex allergy
Description
Anaphylaxis Latex
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023115
- UMLS CUI [1,2]
- C0002792
Description
Angioedema latex
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0023115
Description
Urticaria latex
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042109
- UMLS CUI [1,2]
- C0023115
Description
Past medical conditions: 5. Penicillin allergy
Description
Anaphylactic reaction penicillin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0030827
Description
Angioedema penicillin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0030827
Description
Drug induced urticaria penicillin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0030840
Description
Past medical conditions: 6. Cephalosporin allergy
Description
Anaphylactic reaction to Cephalosporin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0571444
- UMLS CUI [1,2]
- C0600688
- UMLS CUI [1,3]
- C0002792
Description
Angioedema Cephalosporin
Data type
integer
Alias
- UMLS CUI [1,1]
- C3536856
- UMLS CUI [1,2]
- C0002994
Description
Drug induced urticaria Cephalosporin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Description
Past medical conditions: 7. Aspirin allergy
Description
Anaphylactic reaction to aspirin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0004057
Description
Angioedema aspirin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0004057
- UMLS CUI [1,2]
- C0002994
Description
Drug induced urticaria aspirin
Data type
integer
Alias
- UMLS CUI [1,1]
- C0004057
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Description
Past medical conditions: 8. NSAID allergy
Description
Anaphylactic reaction to NSAID
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
Description
Angioedema NSAID
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0003211
Description
Drug induced urticaria NSAID
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003211
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Description
Past medical conditions: 9. ACE inhibitor allergy
Description
Anaphylactic reaction to ACE inhibitor
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
Description
Angioedema ACE inhibitor
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003015
- UMLS CUI [1,2]
- C0002994
Description
Drug induced urticaria ACE inhibitor
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042109
- UMLS CUI [1,2]
- C0600688
- UMLS CUI [1,3]
- C0003015
Description
Other allergies
Description
Symptoms associated with this hypersensitivity reaction: 11. Stevens-Johnson syndrome
Description
Symptoms Stevens-Johnson syndrome
Data type
text
Alias
- UMLS CUI [1]
- C0038325
Description
Blisters Stevens-Johnson syndrome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005758
- UMLS CUI [1,2]
- C0038325
Description
Biopsy confirmed Stevens-Johnson syndrome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0005558
Description
Mucous membrane involvement Stevens-Johnson syndrome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0026724
Description
Stevens-Johnson syndrome Symptom start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0808070
Description
Symptoms associated with this hypersensitivity reaction: 12. Toxic epidermal necrolysis
Description
Symptoms Toxic epidermal necrolysis
Data type
text
Alias
- UMLS CUI [1]
- C0014518
Description
Blisters Toxic epidermal necrolysis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0014518
- UMLS CUI [1,2]
- C0005758
Description
Biopsy confirmed Toxic epidermal necrolysis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0014518
- UMLS CUI [1,2]
- C0005558
Description
Mucous membrane involvement Toxic epidermal necrolysis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0026724
Description
Symptom start date Toxic epidermal necrolysis
Data type
date
Alias
- UMLS CUI [1,1]
- C0026724
- UMLS CUI [1,2]
- C0808070
Description
Symptoms associated with this hypersensitivity reaction: 13. Urticaria (hives)
Description
Symptoms Urticaria (hives)
Data type
text
Description
Generalised Urticaria (hives)
Data type
boolean
Description
Localised Urticaria (hives)
Data type
boolean
Description
Photosensitivity Urticaria (hives)
Data type
boolean
Description
Other symptoms Urticaria (hives)
Data type
boolean
Description
Other symptoms Urticaria (hives) specification
Data type
text
Description
Symptom start date Urticaria (hives)
Data type
date
Description
Symptoms associated with this hypersensitivity reaction: 14. Angioedema
Description
Symptoms Angioedema
Data type
text
Alias
- UMLS CUI [1]
- C0002994
Description
Angioedema Face
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0015450
Description
Angioedema Throat
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0031354
Description
Angioedema Laryngeal
Data type
boolean
Alias
- UMLS CUI [1]
- C0023052
Description
Angioedema Dyspnoea
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0013404
Description
Angioedema Dysphagia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0011168
Description
Angioedema Required intubation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0021925
Description
Angioedema Other symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C3257980
Description
Angioedema Other symptoms specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3257980
- UMLS CUI [1,2]
- C3257980
Description
Symptom start date Angioedema
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0002994
Description
Symptoms associated with this hypersensitivity reaction: 15. Anaphylactic/Anaphylactoid reaction
Description
Anaphylactic/Anaphylactoid reaction symptoms
Data type
text
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
Description
Dyspnoea Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0013404
Description
Bronchospasm Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0006266
Description
Hypotension Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0020649
Description
Loss of consciousness Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0041657
Description
Persistent gastrointestinal symptoms Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0426576
Description
Other symptoms Anaphylactic/Anaphylactoid reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0205394
Description
Other symptoms specidication Anaphylactic/Anaphylactoid reaction
Data type
text
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C3845569
Description
Symptom start date Anaphylactic/Anaphylactoid reaction
Data type
date
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0808070
Description
Symptoms associated with this hypersensitivity reaction: 16. Other symptoms of hypersensitivity reaction
Description
Symptoms Other symptoms of hypersensitivity reaction
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
Description
Other symptoms of hypersensitivity reaction Rash
Data type
boolean
Alias
- UMLS CUI [1]
- C0015230
Description
Other symptoms of hypersensitivity reaction Photosensitivity
Data type
boolean
Alias
- UMLS CUI [1]
- C0349506
Description
Other symptoms of hypersensitivity reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
Description
Other symptoms of hypersensitivity reaction specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C3845569
Description
Start date Other symptoms of hypersensitivity reaction
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
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Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903
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