ID
35861
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Trefwoorden
Versies (2)
- 25-03-19 25-03-19 -
- 29-03-19 29-03-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Solicited adverse events - local and general symptoms, Unsolicited AE
Beschrijving
Solicited adverse events - local symptoms
Alias
- UMLS CUI-1
- C1517001
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0042196
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beschrijving
Local symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschrijving
Tick for each symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0150312
Beschrijving
Please tick intensity for each local symptom for every day.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beschrijving
Fill in for each redness and swelling/induration.
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0518690
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
Beschrijving
Local Symptom ongoing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Solicited adverse events - general symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beschrijving
General symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
Beschrijving
Tick for each symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0150312
Beschrijving
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".
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beschrijving
If you don't take body temperature, please tick "not taken".
Datatype
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschrijving
Temperature to be reported: Axillary >= 37.5°C, >= 99.5°F Oral >= 37.5°C, >= 99.5° Rectal >= 38.0°C, >= 100.4°F
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Body temperature, Unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Symptom ongoing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Beschrijving
Causality of symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1457887
Beschrijving
Unsolicited Adverse events
Alias
- UMLS CUI-1
- C4055646
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0042196
Beschrijving
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"
Datatype
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])