ID
28310
Beschreibung
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)
Stichworte
Versionen (5)
- 04.10.17 04.10.17 -
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- 01.01.18 01.01.18 -
- 03.01.18 03.01.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Januar 2018
DOI
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Lizenz
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
Beschreibung
Past medical conditions: 2. Food allergies
Beschreibung
Past medical conditions: 3. Hymenoptera sting allergy
Beschreibung
Anaphylaxis Hymenoptera sting allergy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002792
Beschreibung
Angioedema Hymenoptera sting allergy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002994
Beschreibung
Urticaria Hymenoptera sting allergy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042109
Beschreibung
Past medical conditions: 4. Latex allergy
Beschreibung
Anaphylaxis Latex
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023115
- UMLS CUI [1,2]
- C0002792
Beschreibung
Angioedema latex
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0023115
Beschreibung
Urticaria latex
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042109
- UMLS CUI [1,2]
- C0023115
Beschreibung
Past medical conditions: 5. Penicillin allergy
Beschreibung
Anaphylactic reaction penicillin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0030827
Beschreibung
Angioedema penicillin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0030827
Beschreibung
Drug induced urticaria penicillin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0030840
Beschreibung
Past medical conditions: 6. Cephalosporin allergy
Beschreibung
Anaphylactic reaction to Cephalosporin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0571444
- UMLS CUI [1,2]
- C0600688
- UMLS CUI [1,3]
- C0002792
Beschreibung
Angioedema Cephalosporin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3536856
- UMLS CUI [1,2]
- C0002994
Beschreibung
Drug induced urticaria Cephalosporin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Beschreibung
Past medical conditions: 7. Aspirin allergy
Beschreibung
Anaphylactic reaction to aspirin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0004057
Beschreibung
Angioedema aspirin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0004057
- UMLS CUI [1,2]
- C0002994
Beschreibung
Drug induced urticaria aspirin
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0004057
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Beschreibung
Past medical conditions: 8. NSAID allergy
Beschreibung
Anaphylactic reaction to NSAID
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
Beschreibung
Angioedema NSAID
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0003211
Beschreibung
Drug induced urticaria NSAID
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0003211
- UMLS CUI [1,2]
- C0042109
- UMLS CUI [1,3]
- C0600688
Beschreibung
Past medical conditions: 9. ACE inhibitor allergy
Beschreibung
Anaphylactic reaction to ACE inhibitor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600688
- UMLS CUI [1,2]
- C0002792
Beschreibung
Angioedema ACE inhibitor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0003015
- UMLS CUI [1,2]
- C0002994
Beschreibung
Drug induced urticaria ACE inhibitor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042109
- UMLS CUI [1,2]
- C0600688
- UMLS CUI [1,3]
- C0003015
Beschreibung
Other allergies
Beschreibung
Symptoms associated with this hypersensitivity reaction: 11. Stevens-Johnson syndrome
Beschreibung
Symptoms Stevens-Johnson syndrome
Datentyp
text
Alias
- UMLS CUI [1]
- C0038325
Beschreibung
Blisters Stevens-Johnson syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005758
- UMLS CUI [1,2]
- C0038325
Beschreibung
Biopsy confirmed Stevens-Johnson syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0005558
Beschreibung
Mucous membrane involvement Stevens-Johnson syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0026724
Beschreibung
Stevens-Johnson syndrome Symptom start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0038325
- UMLS CUI [1,2]
- C0808070
Beschreibung
Symptoms associated with this hypersensitivity reaction: 12. Toxic epidermal necrolysis
Beschreibung
Symptoms Toxic epidermal necrolysis
Datentyp
text
Alias
- UMLS CUI [1]
- C0014518
Beschreibung
Blisters Toxic epidermal necrolysis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0014518
- UMLS CUI [1,2]
- C0005758
Beschreibung
Biopsy confirmed Toxic epidermal necrolysis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0014518
- UMLS CUI [1,2]
- C0005558
Beschreibung
Mucous membrane involvement Toxic epidermal necrolysis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0026724
Beschreibung
Symptom start date Toxic epidermal necrolysis
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0026724
- UMLS CUI [1,2]
- C0808070
Beschreibung
Symptoms associated with this hypersensitivity reaction: 13. Urticaria (hives)
Beschreibung
Symptoms Urticaria (hives)
Datentyp
text
Beschreibung
Generalised Urticaria (hives)
Datentyp
boolean
Beschreibung
Localised Urticaria (hives)
Datentyp
boolean
Beschreibung
Photosensitivity Urticaria (hives)
Datentyp
boolean
Beschreibung
Other symptoms Urticaria (hives)
Datentyp
boolean
Beschreibung
Other symptoms Urticaria (hives) specification
Datentyp
text
Beschreibung
Symptom start date Urticaria (hives)
Datentyp
date
Beschreibung
Symptoms associated with this hypersensitivity reaction: 14. Angioedema
Beschreibung
Symptoms Angioedema
Datentyp
text
Alias
- UMLS CUI [1]
- C0002994
Beschreibung
Angioedema Face
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0015450
Beschreibung
Angioedema Throat
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0031354
Beschreibung
Angioedema Laryngeal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023052
Beschreibung
Angioedema Dyspnoea
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0013404
Beschreibung
Angioedema Dysphagia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0011168
Beschreibung
Angioedema Required intubation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C0021925
Beschreibung
Angioedema Other symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002994
- UMLS CUI [1,2]
- C3257980
Beschreibung
Angioedema Other symptoms specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3257980
- UMLS CUI [1,2]
- C3257980
Beschreibung
Symptom start date Angioedema
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0002994
Beschreibung
Symptoms associated with this hypersensitivity reaction: 15. Anaphylactic/Anaphylactoid reaction
Beschreibung
Anaphylactic/Anaphylactoid reaction symptoms
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
Beschreibung
Dyspnoea Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0013404
Beschreibung
Bronchospasm Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0006266
Beschreibung
Hypotension Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0020649
Beschreibung
Loss of consciousness Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0041657
Beschreibung
Persistent gastrointestinal symptoms Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0426576
Beschreibung
Other symptoms Anaphylactic/Anaphylactoid reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0205394
Beschreibung
Other symptoms specidication Anaphylactic/Anaphylactoid reaction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C3845569
Beschreibung
Symptom start date Anaphylactic/Anaphylactoid reaction
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0340865
- UMLS CUI [1,2]
- C0002792
- UMLS CUI [1,3]
- C0808070
Beschreibung
Symptoms associated with this hypersensitivity reaction: 16. Other symptoms of hypersensitivity reaction
Beschreibung
Symptoms Other symptoms of hypersensitivity reaction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
Beschreibung
Other symptoms of hypersensitivity reaction Rash
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015230
Beschreibung
Other symptoms of hypersensitivity reaction Photosensitivity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0349506
Beschreibung
Other symptoms of hypersensitivity reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
Beschreibung
Other symptoms of hypersensitivity reaction specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C3845569
Beschreibung
Start date Other symptoms of hypersensitivity reaction
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
Ähnliche Modelle
Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903
C0030827 (UMLS CUI [1,2])
C0042109 (UMLS CUI [1,2])
C0030840 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,3])
C0002994 (UMLS CUI [1,2])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0038325 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
C0026724 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0005758 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
C0026724 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0015450 (UMLS CUI [1,2])
C0031354 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,2])
C0011168 (UMLS CUI [1,2])
C0021925 (UMLS CUI [1,2])
C3257980 (UMLS CUI [1,2])
C3257980 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0006266 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0020649 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0041657 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3845569 (UMLS CUI [1,4])
C0002792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])