ID

32907

Description

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form asks for concomitant medications of the subject. It should be filled out at first visit, and re-checked at each subsequent visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Keywords

Versions (3)
  1. 11/1/18 11/1/18 -
  2. 11/17/18 11/17/18 -
  3. 11/19/18 11/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during study period?
Description

if yes, please complete the following table.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Medication Data
Description

Medication Data

Alias
UMLS CUI-1
C2347852
Trade/Name of Medication
Description

Trade/Name of Medication

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Description

Medical Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Prophylactic Medication
Description

Prophylactic Medication

Data type

boolean

Alias
UMLS CUI [1]
C0420172
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Medication Route
Description

Medication Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date of Medication
Description

Start Date of Medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date of Medication
Description

End Date of Medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing Medication
Description

Continuing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Comment for GSK
Description

Only to be filled out by GSK staff members

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Have any medications/treatments been administered during study period?
boolean
C2347852 (UMLS CUI [1])
Item Group
Medication Data
C2347852 (UMLS CUI-1)
Trade/Name of Medication
Item
Trade/Name of Medication
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic Medication
Item
Prophylactic Medication
boolean
C0420172 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Start Date of Medication
Item
Start Date of Medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of Medication
Item
End Date of Medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing Medication
Item
Continuing Medication
boolean
C2826666 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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