Informações:
Falhas:
ID
35379
Descrição
Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Serious Adverse Events (SAE) form. It has to be filled in if a SAE occurs during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00852540
Palavras-chave
Versões (1)
- 04/03/2019 04/03/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de março de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540
Serious Adverse Events (SAE)
- StudyEvent: ODM
Similar models
Serious Adverse Events (SAE)
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Did SAE occur after initiation of study medication?
text
C2745955 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Event Diagnosis, SAE
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Start Date of SAE
Item
Start Date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
CL Item
Fatal (5)
Stop Date of SAE, Date of death
Item
Stop Date of SAE, Date of death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
Item
Maximum Intensity of SAE
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action 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
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the SAE caused by activities related to study participation other than investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Was the SAE caused by activities related to study participation other than investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Intensity changes, SAE
C1710066 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0518690 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Event Diagnosis, SAE
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Start Date of event segment
Item
Start Date of event segment
date
C0808070 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Start Time of event segment
Item
Start Time of event segment
time
C0449719 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Intensity of event segment
integer
C0449719 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C0449719 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
integer
C0449719 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0449719 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C2985911 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0449719 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C2985911 (UMLS CUI [2,3])
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Requires hospitalisation/prolongation of existing hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Other seriousness
Item
Other seriousness
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
Item Group
Relevant concomitant medications/treatment medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Dose of drug
Item
Dose of drug
text
C0678766 (UMLS CUI [1])
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At Bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Start date of medication
Item
Start date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
End date of medication
Item
If not ongoing, specify End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Primary Indication of medication
Item
Primary Indication of medication
text
C2826696 (UMLS CUI [1])
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Relevant medical conditions/risk factors, SAE
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Disease continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurrence
Item
If disease not continuing, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Relevant diagnostic results, SAE
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
Other relevant diagnostic results
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2347900 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2347900 (UMLS CUI [1,4])
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (NA)
CL Item
Topical Study Drug (1)
CL Item
Oral Study Drug (2)
Start Date of study drug
Item
Start Date of study drug
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Item
Study drug, dose level
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Dose level 1 (1)
CL Item
Dose level 2 (2)
CL Item
Dose level 3 (3)
Start Date of study drug
Item
Start Date of study drug
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Item
Study drug, course
integer
C0304229 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
Course 1 (1)
CL Item
Course 2 (2)
CL Item
Course 3 (3)
Start Date of study drug
Item
Start Date of study drug
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Dose of medication
Item
Dose of medication
text
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Cumulative Dose
Item
Cumulative Dose
text
C2986497 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])