ID
35861
Beschreibung
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
Stichworte
Versionen (2)
- 25.03.19 25.03.19 -
- 29.03.19 29.03.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
29. März 2019
DOI
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Lizenz
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
Beschreibung
Solicited adverse events - local symptoms
Alias
- UMLS CUI-1
- C1517001
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0042196
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beschreibung
Local symptoms
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschreibung
Tick for each symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0150312
Beschreibung
Please tick intensity for each local symptom for every day.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beschreibung
Fill in for each redness and swelling/induration.
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0518690
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Local Symptom ongoing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Solicited adverse events - general symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2368628
Beschreibung
General symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
Beschreibung
Tick for each symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0150312
Beschreibung
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".
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Beschreibung
If you don't take body temperature, please tick "not taken".
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschreibung
Temperature to be reported: Axillary >= 37.5°C, >= 99.5°F Oral >= 37.5°C, >= 99.5° Rectal >= 38.0°C, >= 100.4°F
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Body temperature, Unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Symptom ongoing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0159028
Beschreibung
Causality of symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1457887
Beschreibung
Unsolicited Adverse events
Alias
- UMLS CUI-1
- C4055646
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0042196
Beschreibung
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"
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0008679
Ähnliche Modelle
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])