ID

44766

Beschrijving

Documentation part: Adverse Events & Clinical Outcome Evaluation A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline

Trefwoorden

  1. 27-06-16 27-06-16 -
  2. 27-06-16 27-06-16 -
  3. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
  4. 17-11-21 17-11-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 november 2021

DOI

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Licentie

Creative Commons BY-NC 4.0

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Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

Adverse Events (AE)
Beschrijving

Adverse Events (AE)

Event (diagnosis only, otherwise sign/symptom)
Beschrijving

Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Modified term
Beschrijving

Modified term

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

Maateenheden
  • DDMONYYYY
Alias
UMLS CUI [1]
C0808070
DDMONYYYY
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
Beschrijving

If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time

Datatype

text

Alias
UMLS CUI [1]
C0806020
UMLS CUI [2]
C1522314
If "Fatal", record Date and Time of Death
Beschrijving

If

Datatype

text

Alias
UMLS CUI [1]
C1148348
UMLS CUI [2]
C1301931
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Actions taken with Investigational Product(s) as a Result of the AE
Beschrijving

Actions taken with Investigational Product

Datatype

text

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschrijving

Did the subject withdraw from study as a result of this AE?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datatype

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C0877248
Does the Adverse Event meet the definition of serious?
Beschrijving

If Yes, complete paper SAE form and fax to GSK Safety within 24 hr

Datatype

text

Alias
UMLS CUI [1]
C1710056
If "Yes", check all that apply
Beschrijving

If "Yes", check all that apply

Datatype

text

Alias
UMLS CUI [1]
C1710056
If "Other", please specify
Beschrijving

If "Other", please specify

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1710056
Was SAE caused by an activity related to study participation (e.g., procedures)?
Beschrijving

Was SAE caused by an activity related to study participation (e.g., procedures)?

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3641099
Clinical Outcome Determination (OUT)
Beschrijving

Clinical Outcome Determination (OUT)

Clinical success
Beschrijving

Clinical success

Datatype

text

Alias
UMLS CUI [1]
C0085565
Clinical recurrence
Beschrijving

Clinical recurrence

Datatype

text

Alias
UMLS CUI [1]
C0679254
If "Yes", please specify if this was due to Primary or Secondary lesion:
Beschrijving

If

Datatype

text

Alias
UMLS CUI [1,1]
C3640841
UMLS CUI [1,2]
C1402294
UMLS CUI [2,1]
C3640841
UMLS CUI [2,2]
C1519215
Date of recurrence
Beschrijving

Date of recurrence

Datatype

date

Maateenheden
  • DDMONYYYY
Alias
UMLS CUI [1]
C0807712
DDMONYYYY
Unable to determine clinical outcome, please specify:
Beschrijving

Unable to determine clinical outcome, please specify:

Datatype

text

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C3845108

Similar models

Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Events (AE)
Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C0877248 (UMLS CUI [1])
Modified term
Item
Modified term
text
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae (4)
CL Item
Fatal (5)
If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
Item
If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
text
C0806020 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
If
Item
If "Fatal", record Date and Time of Death
text
C1148348 (UMLS CUI [1])
C1301931 (UMLS CUI [2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Actions taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Code List
Actions taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Doce increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C3641099 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Does the Adverse Event meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Code List
Does the Adverse Event meet the definition of serious?
CL Item
No (N)
CL Item
Yes (Y)
Item
If "Yes", check all that apply
text
C1710056 (UMLS CUI [1])
Code List
If "Yes", check all that apply
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation  (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other (F)
If "Other", please specify
Item
If "Other", please specify
text
C2348235 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item
Was SAE caused by an activity related to study participation (e.g., procedures)?
text
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
Code List
Was SAE caused by an activity related to study participation (e.g., procedures)?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Clinical Outcome Determination (OUT)
Item
Clinical success
text
C0085565 (UMLS CUI [1])
Code List
Clinical success
CL Item
Yes (Y)
CL Item
No (N)
Item
Clinical recurrence
text
C0679254 (UMLS CUI [1])
Code List
Clinical recurrence
CL Item
Yes (Y)
CL Item
No (N)
Item
If "Yes", please specify if this was due to Primary or Secondary lesion:
text
C3640841 (UMLS CUI [1,1])
C1402294 (UMLS CUI [1,2])
C3640841 (UMLS CUI [2,1])
C1519215 (UMLS CUI [2,2])
Code List
If "Yes", please specify if this was due to Primary or Secondary lesion:
CL Item
Primary lesion (P)
CL Item
Secondary lesion (S)
Date of recurrence
Item
Date of recurrence
date
C0807712 (UMLS CUI [1])
Unable to determine clinical outcome, please specify:
Item
Unable to determine clinical outcome, please specify:
text
C0085565 (UMLS CUI [1,1])
C3845108 (UMLS CUI [1,2])

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