ID
35861
Beskrivning
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Solicited adverse events - local and general symptoms and Unsolicited AE form. It has to be filled in for Visit 1 and Visit 3.
Länk
https://clinicaltrials.gov/ct2/show/NCT00510874
Nyckelord
Versioner (2)
- 2019-03-25 2019-03-25 -
- 2019-03-29 2019-03-29 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Solicited adverse events - local and general symptoms, Unsolicited AE
Beskrivning
Solicited adverse events - local symptoms
Alias
- UMLS CUI-1
- C1517001
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0042196
Beskrivning
If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beskrivning
Local symptoms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beskrivning
Tick for each symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0150312
Beskrivning
Please tick intensity for each local symptom for every day.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beskrivning
Fill in for each redness and swelling/induration.
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0518690
Beskrivning
Pain at injection site: Grade 0: None Grade 1: Pain on touching the site, not otherwise. Grade 2: Pain on moving the limb which interferes with normal activities or requires repeated use of pain relievers Grade 3: Significant pain at rest; prevents normal activities as asses
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Local Symptom ongoing
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beskrivning
Solicited adverse events - general symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beskrivning
If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beskrivning
General symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
Beskrivning
Tick for each symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0150312
Beskrivning
Fill in for each symptom. If you ticked "Temperature" as symptom, note the body temperature of subject for each day. If you do not measure tick "not taken".
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beskrivning
If you don't take body temperature, please tick "not taken".
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beskrivning
Temperature to be reported: Axillary >= 37.5°C, >= 99.5°F Oral >= 37.5°C, >= 99.5° Rectal >= 38.0°C, >= 100.4°F
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Body temperature, Unit
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beskrivning
Fill in for each: Fatigue, Headache, Joint pain, Muscle aches, Shivering, sweating increase. Definition: Grade 0: None Grade 1: No effect on normal activities Grade 2: Some interference with normal everyday activities or (for headache, joint or muscle pain) requires repeated use of pain relievers Grade 3: Prevents normal everyday activities as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Symptom ongoing
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Beskrivning
Causality of symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1457887
Beskrivning
Unsolicited Adverse events
Alias
- UMLS CUI-1
- C4055646
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0042196
Beskrivning
If you tick yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. Timepoints: For Dose 1 (Visit 1): between Visit "Day 0" through Visit "Day 21". For Dose 2 (Visit 3): between Visit "Day 21" through Visit "Day 42"
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0008679
Similar models
Solicited adverse events - local and general symptoms, Unsolicited AE
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C1519255 (UMLS CUI [2])
C0008679 (UMLS CUI [3])