ID

37320

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 includes Clinical Chemistry and Haematology lab examinations and results and is to be filled in at Screening, on Days 2 and 3 at 0 hrs and Day 3 at 24 hrs (i.e. Day 4 - 0 hrs) and at Follow-Up for all cohorts and for any repeat analyses.

Link

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

Keywords

Versions (1)
  1. 7/16/19 7/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 16, 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

English

Local Laboratory - Clinical Chemistry and Haematology

1 forms  
Laboratory Administrative Data
Description

Laboratory Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0022885
Type of Visit
Description

Type of Visit

Data type

integer

Alias
UMLS CUI [1]
C3641100
Planned Date/Time of Sample
Description

if applicable on respective Day (Day 2 or 3)

Data type

integer

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1301732
Date and time sample taken
Description

Date/Time of Sample

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0200345
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Has the subject fasted?
Description

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analysis
Description

Clinical Chemistry Analysis

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Clinical chemistry lab test
Description

Fill in the following items for each analysed feature at all visits (except for repeat assessments). The following items are not mandatory for Days 2 and 3 for all cohorts: 16 = Prothrombin Time (PT) 17 = Partial Thromboplastin Time (PTT) 19 = International normalized ratio (INR) 22 = Arterial Blood pH 23 = Serum Estradiol item 22 = Arterial Blood pH is not mandatory for Follow-up Select the appropriate feature for Repeat Analysis. The inclusion of 23 = Serum Estradiol during Screening and Follow-Up is a change to the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Clinical chemistry result type
Description

Clinical chemistry result type

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Clinical chemistry numeric result
Description

if applicable

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical chemistry character result
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C2350015
Haematology Lab Analysis
Description

Haematology Lab Analysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Haematology Lab test
Description

Select the appropriate feature for Repeat Analysis At all other visits, fill in the following items for each analysed feature.

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
Haematology Lab result type
Description

Haematology Lab result type

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0332307
Haematology Lab numeric result
Description

if applicable

Data type

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C2347373
Haematology Lab character result
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C2350015
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Similar models

Local Laboratory - Clinical Chemistry and Haematology

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory Administrative Data
C1320722 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1])
Type of Visit
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Follow-up (4)
CL Item
Repeat Assessment (5)
Item
Planned Date/Time of Sample
integer
C1264639 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Planned Date/Time of Sample
Code List
Planned Date/Time of Sample
CL Item
0 hrs (1)
CL Item
24 hrs (2)
Date/Time of Sample
Item
Date and time sample taken
datetime
C1264639 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item Group
Clinical Chemistry Analysis
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Item
Clinical chemistry lab test
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Clinical chemistry lab test
Code List
Clinical chemistry lab test
CL Item
Alanine aminotransferase (ALT/SGPT) (1)
CL Item
Aspartate aminotransferase (AST/SGOT) (2)
CL Item
Total Bilirubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Blood urea nitrogen (BUN) (5)
CL Item
Glucose (6)
CL Item
Gamma glutamyltransferase (GGT) (7)
CL Item
Total Protein (8)
CL Item
Albumin (9)
CL Item
Potassium (10)
CL Item
Sodium (11)
CL Item
Calcium (12)
CL Item
Chloride (13)
CL Item
Total CO2 (14)
CL Item
Creatinine (15)
CL Item
Prothrombin Time (PT) (16)
CL Item
Partial Thromboplastin Time (PTT) (17)
CL Item
Creatinine Kinase (CK) (18)
CL Item
International normalized ratio (INR) (19)
CL Item
Uric Acid (20)
CL Item
Alkaline Phosphatase (21)
CL Item
Arterial Blood pH (22)
CL Item
Serum Estradiol (23)
Item
Clinical chemistry result type
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Clinical chemistry result type
Code List
Clinical chemistry result type
CL Item
Numeric result (97)
CL Item
Character result (98)
CL Item
No result (99)
Clinical chemistry numeric result
Item
Clinical chemistry numeric result
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical chemistry character result
Item
Clinical chemistry character result
text
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item Group
Haematology Lab Analysis
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Haematology Lab test
integer
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology Lab test
Code List
Haematology Lab test
CL Item
RBC (1)
CL Item
Reticulocytes (2)
CL Item
Haemoglobin (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
WBC (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
Eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Item
Haematology Lab result type
integer
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Haematology Lab result type
Code List
Haematology Lab result type
CL Item
Numeric result (97)
CL Item
Character result (98)
CL Item
No result (99)
Haematology Lab numeric result
Item
Haematology Lab numeric result
float
C0018941 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Haematology Lab character result
Item
Haematology Lab character result
text
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
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