ID

44766

Description

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

Keywords

Versions (4)
  1. 6/27/16 6/27/16 -
  2. 6/27/16 6/27/16 -
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 11/17/21 11/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 17, 2021

DOI

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License

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

English

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

1 forms  
Adverse Events (AE)
Description

Adverse Events (AE)

Event (diagnosis only, otherwise sign/symptom)
Description

Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Modified term
Description

Modified term

Data type

text

Start date
Description

Start date

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0808070
DDMONYYYY
Outcome
Description

Outcome

Data type

text

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

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

Data type

text

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

If

Data type

text

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

Maximum Intensity

Data type

integer

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

Actions taken with Investigational Product

Data type

text

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

text

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

If "Yes", check all that apply

Data type

text

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

If "Other", please specify

Data type

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)?
Description

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

Data type

text

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

Clinical Outcome Determination (OUT)

Clinical success
Description

Clinical success

Data type

text

Alias
UMLS CUI [1]
C0085565
Clinical recurrence
Description

Clinical recurrence

Data type

text

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

If

Data type

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
Description

Date of recurrence

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0807712
DDMONYYYY
Unable to determine clinical outcome, please specify:
Description

Unable to determine clinical outcome, please specify:

Data type

text

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

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Outcome
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])
Maximum Intensity
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])
Actions taken with Investigational Product
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])
Does the Adverse Event meet the definition of serious?
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])
If "Yes", check all that apply
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])
Was SAE caused by an activity related to study participation (e.g., procedures)?
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])
Clinical success
Code List
Clinical success
CL Item
Yes (Y)
CL Item
No (N)
Item
Clinical recurrence
text
C0679254 (UMLS CUI [1])
Clinical failure
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])
If "Yes", please specify if this was due to Primary or Secondary lesion:
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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