ID

35379

Description

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

Keywords

Versions (1)
  1. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2019

DOI

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License

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

English

Serious Adverse Events (SAE)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Description

Occurrence of SAE after initiation of study medication

Data type

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0304229
Serious Adverse Events
Description

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Include one event term only

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1519255
Start Date of SAE
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome of SAE
Description

Outcome of SAE

Data type

integer

Alias
UMLS CUI [1]
C1705586
Stop Date of SAE, Date of death
Description

day month year. Fill in if there is a recovered/resolved/resolved with sequelae SAE. Record the date of death if SAE's fatal.

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
Maximum Intensity of SAE
Description

Record maximum intensity throughout duration of event

Data type

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product(s) as a Result of the AE

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Description

Withdraw

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Use best judgment at initial entry. May be amended when additional information becomes available.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Was the SAE caused by activities related to study participation other than investigational product?
Description

(e.g. procedures, blood draws, washout, etc)

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Intensity changes, SAE
Description

Intensity changes, SAE

Alias
UMLS CUI-1
C1710066
UMLS CUI-2
C0518690
UMLS CUI-3
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Include one event term only

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1519255
Start Date of event segment
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C1519255
Start Time of event segment
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1301880
Intensity of event segment
Description

Intensity of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0518690
Grade of event segment
Description

Grade of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C2985911
Grade or Intensity of event segment
Description

Grade or Intensity of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0518690
UMLS CUI [2,1]
C0449719
UMLS CUI [2,2]
C1519255
UMLS CUI [2,3]
C2985911
Seriousness, SAE
Description

Seriousness, SAE

Alias
UMLS CUI-1
C1710056
Results in death
Description

Results in death

Data type

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Is life-threatening
Description

Is life-threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C1519255
Requires hospitalisation or prolongation of existing hospitalisation
Description

Requires hospitalisation/prolongation of existing hospitalisation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Description

Results in disability/incapacity

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Description

Congenital anomaly/birth defect

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other seriousness
Description

If other, specify within general narrative comment

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
Relevant concomitant medications/treatment medications
Description

Relevant concomitant medications/treatment medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0304229
Drug name
Description

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose of drug
Description

Dose of drug

Data type

text

Alias
UMLS CUI [1]
C0678766
Unit
Description

Unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
Frequency of medication
Description

Frequency of medication

Data type

integer

Alias
UMLS CUI [1]
C3476109
Route of medication
Description

Route of medication

Data type

integer

Alias
UMLS CUI [1]
C0013153
Start date of medication
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication ongoing?
Description

Medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
If not ongoing, specify End Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Primary Indication of medication
Description

Enter a medical diagnosis not description

Data type

text

Alias
UMLS CUI [1]
C2826696
Drug type
Description

Drug type

Data type

integer

Alias
UMLS CUI [1]
C0457591
Relevant medical conditions/risk factors, SAE
Description

Relevant medical conditions/risk factors, SAE

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition Name
Description

Enter a medical diagnosis not description.

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0574845
Disease continuing?
Description

Disease continuing

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If disease not continuing, specify date of last occurrence
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Relevant diagnostic results, SAE
Description

Relevant diagnostic results, SAE

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
UMLS CUI-3
C1519255
Test Name
Description

Test Name

Data type

integer

Alias
UMLS CUI [1]
C0022885
Test Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Description

Normal Low Range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Description

Normal High Range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Description

Other relevant diagnostic results

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Rechallenge, SAE
Description

Rechallenge, SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

Recurence of reported event(s) after investigational products

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2347900
Investigational Product 1
Description

Investigational Product 1

Alias
UMLS CUI-1
C0304229
Study drug
Description

Study drug

Data type

integer

Alias
UMLS CUI [1]
C0304229
Start Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Stop Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational Product 2
Description

Investigational Product 2

Alias
UMLS CUI-1
C0304229
Study drug, dose level
Description

Study drug, dose level

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Start Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational Product 3
Description

Investigational Product 3

Alias
UMLS CUI-1
C0304229
Study drug, course
Description

Study drug, course

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0750729
Start Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date of study drug
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Dose of medication
Description

Dose of medication

Data type

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
Cumulative Dose
Description

Cumulative Dose

Data type

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0304229
General narrative comments
Description

General narrative comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
General narrative comments
Description

General narrative comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Similar models

Serious Adverse Events (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (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])
Occurrence of SAE after initiation of study medication
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
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])
Start Date of SAE
Item
Start Date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of SAE
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])
Item
Maximum Intensity of SAE
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity of SAE
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])
Action Taken with Investigational Product(s) as a Result of the AE
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])
Withdraw
Code List
Did the subject withdraw from study as a result of this SAE?
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])
Relationship to investigational products
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])
Cause of SAE
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)
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])
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])
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])
Item
Intensity of event segment
integer
C0449719 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Maximum Intensity
Code List
Intensity of event segment
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])
Grade of event segment
Code List
Grade of event segment
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])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
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)
Item Group
Seriousness, SAE
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
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])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
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])
Other seriousness
Item
Other seriousness
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Relevant concomitant medications/treatment medications
C1519255 (UMLS CUI-1)
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])
Item
Unit
integer
C1519795 (UMLS CUI [1])
Unit
Code List
Unit
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)
Item
Frequency of medication
integer
C3476109 (UMLS CUI [1])
Frequency of medication
Code List
Frequency of medication
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)
Item
Route of medication
integer
C0013153 (UMLS CUI [1])
Route of medication
Code List
Route of medication
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])
Item
Medication ongoing?
text
C2826666 (UMLS CUI [1])
Ongoing of medication
Code List
Medication ongoing?
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])
Primary Indication of medication
Item
Primary Indication of medication
text
C2826696 (UMLS CUI [1])
Item
Drug type
integer
C0457591 (UMLS CUI [1])
Drug type
Code List
Drug type
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)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
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])
Disease continuing
Code List
Disease continuing?
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])
Item Group
Relevant diagnostic results, SAE
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Item
Test Name
integer
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
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])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
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])
Item Group
Rechallenge, SAE
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
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])
Recurence of reported event(s) after investigational products
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)
Item Group
Investigational Product 1
C0304229 (UMLS CUI-1)
Item
Study drug
integer
C0304229 (UMLS CUI [1])
Study drug
Code List
Study drug
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])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
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])
Item Group
Investigational Product 2
C0304229 (UMLS CUI-1)
Item
Study drug, dose level
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Study drug, dose level
Code List
Study drug, dose level
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])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Investigational Product 3
C0304229 (UMLS CUI-1)
Item
Study drug, course
integer
C0304229 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Study drug, dose level
Code List
Study drug, course
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])
Stop Date of study drug
Item
Stop Date of study drug
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Dose of medication
Item
Dose of medication
text
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Cumulative Dose
Item
Cumulative Dose
text
C2986497 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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