ID
37411
Beskrivning
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).
Länk
https://clinicaltrials.gov/ct2/show/NCT00996840
Nyckelord
Versioner (1)
- 2019-07-24 2019-07-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 juli 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
SB-681323 in ALI/ARDS risk patients - NCT00996840
Liver Events
- StudyEvent: ODM
Beskrivning
Liver Events - Lab
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0008000
Beskrivning
ALT reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
AST reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Total bilirubin reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Alkaline phosphatase reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
5' nucleotidase reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Gamma-glutamyltranspeptidase reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Other liver chemistry result reached stopping criteria
Datatyp
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
Beskrivning
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beskrivning
Age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
If yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
f Yes, answer whether the results were normal
Datatyp
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
Beskrivning
If applicable If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
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
Beskrivning
If yes, complete Liver Biopsy form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beskrivning
If yes, record on the appropriate Concomitant Medication form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beskrivning
Recent fasting or significant dietary change
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826267
Beskrivning
Investigational Product Liver
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beskrivning
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
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beskrivning
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.
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
Beskrivning
Pharmakokinetics Liver
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
- UMLS CUI-3
- C0023884
Beskrivning
An unscheduled PK blood sample must be obtained within 2 hours of last dose. If yes, answer following three items.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
if applicable
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beskrivning
if applicable
Datatyp
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
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Beskrivning
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beskrivning
Acute type A viral hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276434
Beskrivning
Hepatitis B, Chronic
Datatyp
integer
Alias
- UMLS CUI [1]
- C0524909
Beskrivning
Hepatitis C, Chronic
Datatyp
integer
Alias
- UMLS CUI [1]
- C0524910
Beskrivning
Cytomegalovirus Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276252
Beskrivning
Infectious Mononucleosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021345
Beskrivning
Herpes Simplex Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C1963747
Beskrivning
Alcoholic Liver Diseases
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023896
Beskrivning
Non-alcoholic Steatohepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Fatty Liver
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015695
Beskrivning
Hepatic Cirrhosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Hemochromatosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Autoimmune Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
Gall Bladder Diseases
Datatyp
integer
Alias
- UMLS CUI [1]
- C0016977
Beskrivning
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beskrivning
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Other liver disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Other Liver Disease Conditions - Status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beskrivning
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Drug Allergies
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013182
Beskrivning
Rheumatoid Arthritis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beskrivning
Psoriasis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beskrivning
Thyroid Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beskrivning
Inflammatory Bowel Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Lupus
Datatyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beskrivning
Sjogren's Syndrome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beskrivning
Vitiligo
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beskrivning
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Beskrivning
If Yes, record the average number of units of alcohol consumed per week
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
if applicable
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beskrivning
[hidden]
Datatyp
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])