ID

32076

Beschreibung

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for documentation of unsolicited and solicited adverse events at Visit 3 (Dose 1 of Study Vaccination) and Visit 5 (Dose 2 of Study Vaccination) Visit 3 -> Timing: Day 45, Age: 12 weeks +/- 1 week. Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week.

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Stichworte

Versionen (1)
  1. 17.10.18 17.10.18 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

17. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Englisch

Unsolicited and Solicited Adverse Events post Study Vaccination

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beschreibung

Visit number

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI [1]
C1549755
Unsolicited Adverse Events
Beschreibung

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post HRV/placebo vaccination ?
Beschreibung

if yes: fill in the Non-Serious Adverse Event pages or Serious Adverse Event form.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1518404
Solicited Adverse Events - General Symptoms
Beschreibung

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
Has the subject experienced any of the following signs/symptoms during the solicited period ?
Beschreibung

If yes, please fill in the applicable items of this itemgroup and the Itemgroup "Intensitiy of symptoms". If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Datentyp

text

Alias
UMLS CUI [1]
C0037088
Fever (FE)
Beschreibung

Fever defined as Axillary Temperature above 37.5 °C or Rectal Temperature above 38 °C

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
If fever, give Temperature Site of Meassurement
Beschreibung

Temperature Site of Meassurement

Datentyp

text

Alias
UMLS CUI [1]
C0489453
If Fever, ongoing after day 7?
Beschreibung

Fever Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0449238
If ongoing, Date of last day of fever
Beschreibung

Date of last day of fever

Datentyp

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0806020
If Fever, Causality?
Beschreibung

Fever Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0015127
Irritability / Fussiness (IR)
Beschreibung

Irritability / Fussiness

Datentyp

boolean

Alias
UMLS CUI [1]
C0022107
If Irritability / Fussiness (IR), ongoing after day 7?
Beschreibung

Irritability / Fussiness Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0449238
If ongoing, Date of last day of Irritability / Fussiness (IR)
Beschreibung

Date of last day of Irritability / Fussiness

Datentyp

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0806020
If Irritability / Fussiness (IR): Causality?
Beschreibung

Irritability / Fussiness Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0015127
Loss of Appetite (LO)
Beschreibung

Loss of Appetite

Datentyp

boolean

Alias
UMLS CUI [1]
C1971624
If Loss of Appetite (LO), ongoing after day 7?
Beschreibung

Loss of Appetite Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0449238
If ongoing, Date of last day of Loss of Appetite
Beschreibung

Date of last day of Loss of Appetite

Datentyp

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0806020
If Loss of Appetite (LO): Causality
Beschreibung

Loss of Appetite Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0015127
Vomiting (VO)
Beschreibung

Vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0042963
If Vomiting (VO), ongoing after day 7?
Beschreibung

Vomiting Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0449238
If ongoing, Date of last day of Vomiting
Beschreibung

date of last day of Vomiting

Datentyp

date

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0806020
If Vomiting (VO): Causality?
Beschreibung

Vomiting Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0015127
Diarrhea (DA)
Beschreibung

Stool sample should be collected in case of diarrhea. Please report the stool collection date in the gastroenteritis stoll collection section.

Datentyp

boolean

Alias
UMLS CUI [1]
C0011991
If Diarrhea (DA), ongoing after day 7?
Beschreibung

Diarrhea Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0449238
If ongoing, Date of last day of Diarrhea (DA)
Beschreibung

Date of last day of Diarrhea

Datentyp

date

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0806020
If Diarrhea (DA): Causality?
Beschreibung

Diarrhea Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0015127
Intensity of Symptoms
Beschreibung

Intensity of Symptoms

Alias
UMLS CUI-1
C0518690
Day of symptoms
Beschreibung

Complete this itemgroup repeatedly for each observed general symptom (Itemgroup "Solicited adverese events - general symptoms") for all 8 Days in this item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
If fever, was temperature taken?
Beschreibung

Temperature measurement

Datentyp

text

Alias
UMLS CUI [1]
C0005903
If temperature was taken, give the result
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
If irritable/fussy, give Intensity of irritability / fussiness
Beschreibung

Intensity of irritability / fussiness

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
If loss of appetite, give Intensity
Beschreibung

Intensity of loss of appetite

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
If Vomiting, give Number of times per day
Beschreibung

Times of Vomiting

Datentyp

integer

Maßeinheiten
  • /day
Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C1265611
/day
If Diarrhea, give Number of looser than normal stools per day
Beschreibung

Number of looser than normal stools

Datentyp

integer

Maßeinheiten
  • /day
Alias
UMLS CUI [1,1]
C2129214
UMLS CUI [1,2]
C0439505
/day
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Ähnliche Modelle

Unsolicited and Solicited Adverse Events post Study Vaccination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 3 (Dose 1) (3)
(Comment:en)
CL Item
Visit 5 (Dose 2) (5)
(Comment:en)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post HRV/placebo vaccination ?
text
C1519255 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
any serious or non-serious unsolicited adverse events within 1 month post study vaccination/placebo
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post HRV/placebo vaccination ?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period ?
text
C0037088 (UMLS CUI [1])
any serious or non-serious unsolicited adverse events within 1 month post study vaccination/placebo
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period ?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Fever
Item
Fever (FE)
boolean
C0015967 (UMLS CUI [1])
Item
If fever, give Temperature Site of Meassurement
text
C0489453 (UMLS CUI [1])
Fever Site of Meassurement
Code List
If fever, give Temperature Site of Meassurement
CL Item
Axillary (A)
CL Item
Rectal (R)
Fever Duration
Item
If Fever, ongoing after day 7?
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of fever
Item
If ongoing, Date of last day of fever
date
C0015967 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Fever Causality
Item
If Fever, Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Irritability / Fussiness
Item
Irritability / Fussiness (IR)
boolean
C0022107 (UMLS CUI [1])
Irritability / Fussiness Duration
Item
If Irritability / Fussiness (IR), ongoing after day 7?
boolean
C0022107 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Irritability / Fussiness
Item
If ongoing, Date of last day of Irritability / Fussiness (IR)
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Irritability / Fussiness Causality
Item
If Irritability / Fussiness (IR): Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Loss of Appetite
Item
Loss of Appetite (LO)
boolean
C1971624 (UMLS CUI [1])
Loss of Appetite Duration
Item
If Loss of Appetite (LO), ongoing after day 7?
boolean
C1971624 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Loss of Appetite
Item
If ongoing, Date of last day of Loss of Appetite
date
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Loss of Appetite Causality
Item
If Loss of Appetite (LO): Causality
boolean
C1971624 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Vomiting
Item
Vomiting (VO)
boolean
C0042963 (UMLS CUI [1])
Vomiting Duration
Item
If Vomiting (VO), ongoing after day 7?
boolean
C0042963 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
date of last day of Vomiting
Item
If ongoing, Date of last day of Vomiting
date
C0042963 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Vomiting Causality
Item
If Vomiting (VO): Causality?
boolean
C0042963 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Diarrhea
Item
Diarrhea (DA)
boolean
C0011991 (UMLS CUI [1])
Diarrhea Duration
Item
If Diarrhea (DA), ongoing after day 7?
boolean
C0011991 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Diarrhea
Item
If ongoing, Date of last day of Diarrhea (DA)
date
C0011991 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Diarrhea Causality
Item
If Diarrhea (DA): Causality?
boolean
C0011991 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item Group
Intensity of Symptoms
C0518690 (UMLS CUI-1)
Item
Day of symptoms
text
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Day of symptoms
Code List
Day of symptoms
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
Item
If fever, was temperature taken?
text
C0005903 (UMLS CUI [1])
Temperature measurement
Code List
If fever, was temperature taken?
CL Item
taken (taken)
CL Item
not taken (not taken)
Temperature
Item
If temperature was taken, give the result
float
C0005903 (UMLS CUI [1])
Item
If irritable/fussy, give Intensity of irritability / fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of irritability / fussiness
Code List
If irritable/fussy, give Intensity of irritability / fussiness
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
0 (0)
Item
If loss of appetite, give Intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of loss of appetite
Code List
If loss of appetite, give Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Times of Vomiting
Item
If Vomiting, give Number of times per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Number of looser than normal stools
Item
If Diarrhea, give Number of looser than normal stools per day
integer
C2129214 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
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