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Informações:
Falhas:
ID
16061
Descrição
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
Palavras-chave
Versões (4)
- 27/06/2016 27/06/2016 -
- 27/06/2016 27/06/2016 -
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 17/11/2021 17/11/2021 -
Transferido a
27 de junho de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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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
Similar models
Adverse Events & Clinical Outcome Evaluation Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C1522314 (UMLS CUI [2])
If "Fatal", record Date and Time of Death
Item
If "Fatal", record Date and Time of Death
text
C1148348 (UMLS CUI [1,1])
| C1301931 (UMLS CUI [1,2])
| C1301931 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
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])
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)
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])
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])
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)
CL Item
Yes (Y)
CL Item
No (N)
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])
C1519215 (UMLS CUI [2])
| C1402294 (UMLS CUI [1,2])
C1519215 (UMLS CUI [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])
C3845108 (UMLS CUI [1,2])