Informações:
Falhas:
ID
28310
Descrição
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)
Palavras-chave
Versões (5)
- 04/10/2017 04/10/2017 -
- 16/10/2017 16/10/2017 -
- 23/10/2017 23/10/2017 -
- 01/01/2018 01/01/2018 -
- 03/01/2018 03/01/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
3 de janeiro de 2018
DOI
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Licença
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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Event number
Item
Event number
text
C2826275 (UMLS CUI [1])
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)
Item
Anaphylactic reaction to drug
integer
C0002792 (UMLS CUI [1,1])
C0030827 (UMLS CUI [1,2])
C0030827 (UMLS CUI [1,2])
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Drug induced urticaria
integer
C0600688 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
C0030840 (UMLS CUI [1,3])
C0042109 (UMLS CUI [1,2])
C0030840 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Anaphylactic reaction to drug
integer
C0571444 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Angioedema
integer
C3536856 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,2])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Drug induced urticaria
integer
C0002994 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Anaphylactic reaction to drug
integer
C0600688 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Drug induced urticaria
integer
C0004057 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Anaphylactic reaction to drug
integer
C0600688 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,2])
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Drug induced urticaria
integer
C0003211 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0042109 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Anaphylactic reaction to drug
integer
C0600688 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,2])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Angioedema
integer
C0003015 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,2])
CL Item
Past (2)
CL Item
No medical history (3)
Item
Drug induced urticaria
integer
C0042109 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
CL Item
Past (2)
CL Item
No medical history (3)
Specific Condition Other allergies
Item
10.a Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
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
C0005758 (UMLS CUI [1,1])
C0038325 (UMLS CUI [1,2])
C0038325 (UMLS CUI [1,2])
Biopsy confirmed Stevens-Johnson syndrome
Item
Biopsy confirmed
boolean
C0038325 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
Mucous membrane involvement Stevens-Johnson syndrome
Item
Mucous membrane involvement
boolean
C0038325 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C0026724 (UMLS CUI [1,2])
Stevens-Johnson syndrome Symptom start date
Item
Symptom start date
date
C0038325 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
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
C0014518 (UMLS CUI [1,1])
C0005758 (UMLS CUI [1,2])
C0005758 (UMLS CUI [1,2])
Biopsy confirmed Toxic epidermal necrolysis
Item
Biopsy confirmed
boolean
C0014518 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
Mucous membrane involvement Toxic epidermal necrolysis
Item
Mucous membrane involvement
boolean
C0005558 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C0026724 (UMLS CUI [1,2])
Symptom start date Toxic epidermal necrolysis
Item
Symptom start date
date
C0026724 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
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
C0002994 (UMLS CUI [1,1])
C0015450 (UMLS CUI [1,2])
C0015450 (UMLS CUI [1,2])
Angioedema Throat
Item
Throat (including tongue, larynx)
boolean
C0002994 (UMLS CUI [1,1])
C0031354 (UMLS CUI [1,2])
C0031354 (UMLS CUI [1,2])
Angioedema Laryngeal
Item
Laryngeal
boolean
C0023052 (UMLS CUI [1])
Angioedema Dyspnoea
Item
Dyspnoea
boolean
C0002994 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,2])
Angioedema Dysphagia
Item
Dysphagia
boolean
C0002994 (UMLS CUI [1,1])
C0011168 (UMLS CUI [1,2])
C0011168 (UMLS CUI [1,2])
Angioedema Required intubation
Item
Required intubation
boolean
C0002994 (UMLS CUI [1,1])
C0021925 (UMLS CUI [1,2])
C0021925 (UMLS CUI [1,2])
Angioedema Other symptoms
Item
Other
boolean
C0002994 (UMLS CUI [1,1])
C3257980 (UMLS CUI [1,2])
C3257980 (UMLS CUI [1,2])
Angioedema Other symptoms specification
Item
Other, specify
text
C3257980 (UMLS CUI [1,1])
C3257980 (UMLS CUI [1,2])
C3257980 (UMLS CUI [1,2])
Symptom start date Angioedema
Item
Symptom start date
date
C0808070 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,2])
Item Group
Symptoms associated with this hypersensitivity reaction: 15. Anaphylactic/Anaphylactoid reaction
Item
Symptoms
text
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0002792 (UMLS CUI [1,2])
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Dyspnoea Anaphylactic/Anaphylactoid reaction
Item
Dyspnoea
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,3])
Bronchospasm Anaphylactic/Anaphylactoid reaction
Item
Bronchospasm
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0006266 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0006266 (UMLS CUI [1,3])
Hypotension Anaphylactic/Anaphylactoid reaction
Item
Hypotension
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0020649 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0020649 (UMLS CUI [1,3])
Loss of consciousness Anaphylactic/Anaphylactoid reaction
Item
Loss of consciousness
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0041657 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0041657 (UMLS CUI [1,3])
Persistent gastrointestinal symptoms Anaphylactic/Anaphylactoid reaction
Item
Persistent gastrointestinal symptoms (crampy abdominal pain, vomiting)
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,3])
Other symptoms Anaphylactic/Anaphylactoid reaction
Item
Other
boolean
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other symptoms specidication Anaphylactic/Anaphylactoid reaction
Item
Other, specify
text
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3845569 (UMLS CUI [1,4])
C0002792 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3845569 (UMLS CUI [1,4])
Symptom start date Anaphylactic/Anaphylactoid reaction
Item
Symptom start date
date
C0340865 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0002792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item Group
Symptoms associated with this hypersensitivity reaction: 16. Other symptoms of hypersensitivity reaction
Item
Symptoms
text
C1457887 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Other symptoms of hypersensitivity reaction Rash
Item
Rash
boolean
C0015230 (UMLS CUI [1])
Other symptoms of hypersensitivity reaction Photosensitivity
Item
Photosensitivity
boolean
C0349506 (UMLS CUI [1])
Other symptoms of hypersensitivity reaction
Item
Other
boolean
C1457887 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Other symptoms of hypersensitivity reaction specification
Item
Other, specify
text
C1457887 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Start date Other symptoms of hypersensitivity reaction
Item
Symptom start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])