ID
37411
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 if an Adverse Liver Event occurs, and can be used for investigations such as repeat pharmacokinetic samples or specific medical history relating to this Liver Event, however there are seperate forms for Liver Imaging and Liver Biopsy (if performed).
Link
https://clinicaltrials.gov/ct2/show/NCT00996840
Keywords
Versions (1)
- 7/24/19 7/24/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 24, 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
Liver Events
- StudyEvent: ODM
Description
Liver Events - Lab
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0008000
Description
ALT reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
AST reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Total bilirubin reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Alkaline phosphatase reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
5' nucleotidase reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Gamma-glutamyltranspeptidase reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Other liver chemistry result reached stopping criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0008000
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Description
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If yes, ensure Pregnancy Notification Form has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
f Yes, answer whether the results were normal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C0412534
- UMLS CUI [4]
- C0412620
- UMLS CUI [5]
- C0412693
- UMLS CUI [6]
- C0008310
Description
If applicable If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0456984
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C0023884
Description
If yes, complete Liver Biopsy form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Description
If yes, record on the appropriate Concomitant Medication form.
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Description
Recent fasting or significant dietary change
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826267
Description
Investigational Product Liver
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. If applicale
Data type
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
Description
Pharmakokinetics Liver
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
- UMLS CUI-3
- C0023884
Description
An unscheduled PK blood sample must be obtained within 2 hours of last dose. If yes, answer following three items.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
if applicable
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Description
if applicable
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0945778
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Description
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Description
Acute type A viral hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C0276434
Description
Hepatitis B, Chronic
Data type
integer
Alias
- UMLS CUI [1]
- C0524909
Description
Hepatitis C, Chronic
Data type
integer
Alias
- UMLS CUI [1]
- C0524910
Description
Cytomegalovirus Hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C0276252
Description
Infectious Mononucleosis
Data type
integer
Alias
- UMLS CUI [1]
- C0021345
Description
Herpes Simplex Hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C1963747
Description
Alcoholic Liver Diseases
Data type
integer
Alias
- UMLS CUI [1]
- C0023896
Description
Non-alcoholic Steatohepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C3241937
Description
Fatty Liver
Data type
integer
Alias
- UMLS CUI [1]
- C0015695
Description
Hepatic Cirrhosis
Data type
integer
Alias
- UMLS CUI [1]
- C0023890
Description
Hemochromatosis
Data type
integer
Alias
- UMLS CUI [1]
- C0018995
Description
Autoimmune Hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C0241910
Description
Gall Bladder Diseases
Data type
integer
Alias
- UMLS CUI [1]
- C0016977
Description
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Description
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Other liver disease
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Other Liver Disease Conditions - Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Drug Allergies
Data type
integer
Alias
- UMLS CUI [1]
- C0013182
Description
Rheumatoid Arthritis
Data type
integer
Alias
- UMLS CUI [1]
- C0003873
Description
Psoriasis
Data type
integer
Alias
- UMLS CUI [1]
- C0033860
Description
Thyroid Disease
Data type
integer
Alias
- UMLS CUI [1]
- C0040128
Description
Inflammatory Bowel Disease
Data type
integer
Alias
- UMLS CUI [1]
- C0021390
Description
Lupus
Data type
integer
Alias
- UMLS CUI [1]
- C0409974
Description
Sjogren's Syndrome
Data type
integer
Alias
- UMLS CUI [1]
- C1527336
Description
Vitiligo
Data type
integer
Alias
- UMLS CUI [1]
- C0042900
Description
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Description
If Yes, record the average number of units of alcohol consumed per week
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
if applicable
Data type
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Similar models
Liver Events
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C1272695 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0023884 (UMLS CUI-2)
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0031327 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0041755 (UMLS CUI-2)
C0041755 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])