ID

37356

Description

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in continously during the study and/or at the follow-up evaluation and contains information on other medication the participant has received during the course of the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Keywords

  1. 7/20/19 7/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 2019

DOI

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License

Creative Commons BY-NC 3.0

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SB-681323 in ALI/ARDS risk patients - NCT00996840

Concomitant Medications

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Concomitant Medication Modified Reported Term
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose
Description

Unit Dose

Data type

text

Alias
UMLS CUI [1]
C0869039
Units of concomitant medication
Description

Concomitant Medication Units

Data type

integer

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Description

Concomitant Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Description

Concomitant Medication Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date and Time
Description

Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Concomitant Medication Taken Prior to Study?
Description

Concomitant Medication Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

If no, specify End Date and Time

Data type

boolean

Alias
UMLS CUI [1]
C2826666
If no, specify End Date and Time
Description

End date and time

Data type

datetime

Alias
UMLS CUI [1]
C3899266

Similar models

Concomitant Medications

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Concomitant Medication Modified Reported Term
Item
Concomitant Medication Modified Reported Term
text
C2826819 (UMLS CUI [1])
Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1])
Item
Units of concomitant medication
integer
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Units of concomitant medication
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Drops (9)
CL Item
Finger tip unit (10)
CL Item
Gramma per kilogram per minute (11)
CL Item
Gram (12)
CL Item
Grams per kilogram (13)
CL Item
Grams per litre (14)
CL Item
Grams per metre squared (15)
CL Item
Grams per millilitre (16)
CL Item
Inhalation (17)
CL Item
100 International units/ml (18)
CL Item
International units per kilogram (19)
CL Item
International units per kilogram per hour (20)
CL Item
International units per millilitre (21)
CL Item
Litre (22)
CL Item
Litres per minute (23)
CL Item
Lozenge (24)
CL Item
Mega becquerels (MBq) (25)
CL Item
Megaunits (million units) (26)
CL Item
Microgram (MCG) (27)
CL Item
Microgram (UG) (28)
CL Item
Micrograms per gram (29)
CL Item
Micrograms per hour (30)
CL Item
Microgram per kilogram (31)
CL Item
Microgram per kilogram per minute (32)
CL Item
Micrograms per millilitre (33)
CL Item
Micrograms per minute (34)
CL Item
Microlitre (35)
CL Item
Micromoles (36)
CL Item
Micromoles per 24 hours (37)
CL Item
Millicurie (38)
CL Item
Milliequivalent (39)
CL Item
Milliequivalents per 24 hours (40)
CL Item
Milligram (41)
CL Item
Milligram per day (42)
CL Item
Milligram per hour (43)
CL Item
Milligram per kilogram (44)
CL Item
Milligram per kilogram per hour (45)
CL Item
Milligram per kilogram per minute (46)
CL Item
Milligrams per metre squared (47)
CL Item
Milligrams per millilitre (48)
CL Item
Milligrams percent (49)
CL Item
Millilitre (50)
CL Item
Millilitres per hour (51)
CL Item
Millilitres per minute (52)
CL Item
Millimole (53)
CL Item
Millimoles per kilogram (54)
CL Item
Millimoles per millilitre (55)
CL Item
Million international unit (56)
CL Item
Minimum alveolar concentration (57)
CL Item
Nanogram per kilogram per minute (58)
CL Item
Nebule (59)
CL Item
Ounce (60)
CL Item
Pack (61)
CL Item
Patch (62)
CL Item
Percent (63)
CL Item
Puff (64)
CL Item
Ring (65)
CL Item
Sachet (66)
CL Item
Spray (67)
CL Item
Suppository (68)
CL Item
Tablet (69)
CL Item
Tablespoon (70)
CL Item
Teaspoon (71)
CL Item
Units (72)
CL Item
Units per gram (73)
CL Item
Units per hour (74)
CL Item
Units per kilogram per minute (75)
CL Item
Units per minute (76)
CL Item
Unknown (77)
CL Item
Vial (78)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Frequency
CL Item
3 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
once a month (QM)
CL Item
every other day (QOD)
CL Item
QPM (QPM)
CL Item
once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Route
CL Item
Epidural (EP)
CL Item
Gastrostomy tube (GTT)
CL Item
Intra-arterial (IA)
CL Item
Intra-bursa (IB)
CL Item
intradermal (ID)
CL Item
Inhalation (IH)
CL Item
intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Inraocular (IO)
CL Item
Intraosteal (IOS)
CL Item
intraperitoneal (IP)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Jejunostomy feeding tube (JEJ or PEJ) (JEJ)
CL Item
nasogastric (NG)
CL Item
Nasal (NS)
CL Item
right eye (OD)
CL Item
opthalmic (OP)
CL Item
left eye (OS)
CL Item
other (OTH)
CL Item
both eyes (OU)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Transmucosal (TM)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Item
Concomitant Medication Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time
Item
If no, specify End Date and Time
datetime
C3899266 (UMLS CUI [1])

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