ID

37359

Descrição

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 should be filled in in case of a serious adverse event.

Link

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

Palavras-chave

Akute Lungenverletzung

J80

Clinical Trial, Phase II

Adverse event

20/07/2019 20/07/2019 -

Titular dos direitos

GlaxoSmithKline

Transferido a

20 de julho de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

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SB-681323 in ALI/ARDS risk patients - NCT00996840

model
Detalhes

Serious Adverse Event

1 Formulários

StudyEvent: ODM
1. Serious Adverse Event

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative documentation

Item Group

Administrative data

C1320722 (UMLS CUI-1)

Cohort

Item

Cohort

integer

C0599755 (UMLS CUI [1])

Date/Time of Assessment

Item

Date/Time of Assessment

datetime

C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Subject ID

Item

Subject ID

integer

C2348585 (UMLS CUI [1])

Type of Report

Item Group

Type of Report

C0585733 (UMLS CUI-1)

Initial Report

Item

Initial Report

boolean

C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])

Follow-Up Report

Item

Follow-Up Report

boolean

C1704685 (UMLS CUI [1])

Randomisation

Item Group

Randomisation

C0034656 (UMLS CUI-1)

SAE after initiation of study medication

Item

Did SAE occur after initiation of study medication?

boolean

C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])

Serious adverse event

Item Group

Serious adverse event Entry

C1519255 (UMLS CUI-1)

SAE Sequence Number

Item

Sequence Number

text

C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

SAE Diagnosis or Sign/Symptom

Item

Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom

text

C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])

Adverse Event Modified Reported Term

Item

Adverse Event Modified Reported Term

text

C2826798 (UMLS CUI [1])

MedDRA synonym

Item

MedDRA synonym

text

C1140263 (UMLS CUI [1])

MedDRA lower level term code

Item

MedDRA lower level term code

text

C3898442 (UMLS CUI [1])

Failed coding

Item

Failed coding

boolean

C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])

Adverse Event Start Date/Time

Item

Adverse Event Start Date and Time

datetime

C2826806 (UMLS CUI [1])

Adverse Event Outcome

Item

Adverse Event Outcome

integer

C1705586 (UMLS CUI [1])

Outcome

Code List

Adverse Event Outcome

CL Item

Recovered/Resolved, (1)

CL Item

Recovering/Resolving (2)

CL Item

Not recovered/Not resolved (3)

CL Item

Recovered/Resolved with sequelae (4)

CL Item

Fatal (5)

Adverse Event End Date/Time

Item

Adverse Event End Date and Time

datetime

C2826793 (UMLS CUI [1])

Serious Adverse Event Frequency

Item

Serious Adverse Event Frequency

integer

C0439603 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Frequency

Code List

Serious Adverse Event Frequency

CL Item

Single Episode (1)

CL Item

Intermittent (2)

SAE Maximum Intensity

Item

SAE Maximum Intensity

text

C1710066 (UMLS CUI [1])

Maximum Intensity

Code List

SAE Maximum Intensity

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

Not applicable (X)

SAE Maximum Grade

Item

SAE Maximum Grade

text

C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])

Maximum Grade

Code List

SAE Maximum Grade

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)

CL Item

Not applicable (X)

SAE Maximum Grade or Intensity

Item

SAE Maximum Grade or Intensity

text

C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])

Maximum Grade

Code List

SAE Maximum Grade or Intensity

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)

CL Item

Not applicable (X)

Action regarding Investigational Product

Item

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

text

C1704758 (UMLS CUI [1])

Action regarding Investigational Product

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 (X)

subject withdrawal because of AE

Item

Did the subject withdraw from study as a result of this AE?

boolean

C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])

AE possibly caused by investigational product

Item

Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?

boolean

C0304229 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])

Duration of AE

Item

Duration of AE if < 24 hours

time

C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Interval between Last Dose and AE Onset

Item

Time to Onset Since Last Dose

time

C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])

SAE caused by activities related to study participation

Item

Was SAE caused by activities related to study participation (e.g. procedures)?

boolean

C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])

Event seriousness

Item

Was the event serious?

boolean

C1547644 (UMLS CUI [1])

Reasons for Event Seriousness

Item Group

Seriousness

C0566251 (UMLS CUI-1)
C1547644 (UMLS CUI-2)

Adverse Event Results in death

Item

Results in death

boolean

C1320832 (UMLS CUI [1])

Adverse event is life-threatening

Item

Adverse event is life-threatening

boolean

C1517874 (UMLS CUI [1])

adverse event requires hospitalisation or prolongation of hospitalisation

Item

Requires hospitalisation or prolongation of existing hospitalisation

boolean

C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])

Serious adverse event results in disability/incapacity

Item

Results in disability/incapacity

boolean

C3176592 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])

Serious adverse event: Congenital anomaly/birth defect

Item

Serious adverse event: Congenital anomaly/birth defect

boolean

C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Other reason for event seriousness

Item

Other reason

boolean

C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Liver injury and impaired liver function causing prolongation of hospitalisation, by investigator judgement

Item

Is associated with liver injury and impaired liver function that in the judgment of the investigator and medical monitor causes prolongation of hospitalisation out of what would be expected for normal clinical course

boolean

C0160390 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0745041 (UMLS CUI [1,3])
C0086565 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0745041 (UMLS CUI [2,3])
C0008961 (UMLS CUI [3,1])
C0022423 (UMLS CUI [3,2])

Relevant concomitant/treatment medications

Item Group

Relevant concomitant/treatment medications Entry

C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)

Concomitant Medication Sequence Number

Item

CM Sequence Number

text

C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Drug name

Item

Drug name

text

C2360065 (UMLS CUI [1])

Dose

Item

Dose

text

C3174092 (UMLS CUI [1])

Unit of concomitant medication

Item

Unit

text

C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

units of medication

Code List

Unit

CL Item

Actuation (ACTU)

CL Item

Ampoule (AMP)

CL Item

Application (AP)

CL Item

Bottle (BT)

CL Item

Capsule (CAP)

CL Item

Cubic centimeter (CC)

CL Item

Drops (031)

CL Item

Gram (002)

CL Item

International units (025)

CL Item

International units per kilogram (028)

CL Item

International units per millilitre (IUML)

CL Item

Litre (011)

CL Item

Litre per minute (LM)

CL Item

Lozenge (LOZ)

CL Item

Megaunits (million units) (MEGU)

CL Item

Microgram (UG) (004)

CL Item

Microgram (UG) (004)

CL Item

Microgram/kilogram (008)

CL Item

Microgram/kilogram per minute (MCG/KG/MIN)

CL Item

Micrograms per minute (MCG/MIN)

CL Item

Microlitre (013)

CL Item

Milliequivalent (029)

CL Item

Milliequivalent per 24 hours (MEQ24)

CL Item

Milligram (003)

CL Item

Milligrams percent (MGPER)

CL Item

Milligram per hour (MGH)

CL Item

Milligram/kilogram (007)

CL Item

Milligram/kilogram per hour (MGKH)

CL Item

Milligram/kilogram per minute (MGKM)

CL Item

Milligram/metre squared (009)

CL Item

Milligram/millilitre (MGML)

CL Item

Millilitre (012)

CL Item

Millilitre per hour (MLH)

CL Item

Millilitre per minute (MLM)

CL Item

Millimole (023)

CL Item

Million international units (027)

CL Item

Minimum alveolar concentration (MAC)

CL Item

Nebule (NEB)

CL Item

Patch (PAT)

CL Item

Percent (030)

CL Item

Puff (PUFF)

CL Item

Sachet (SAC)

CL Item

Spray (SPR)

CL Item

Suppository (SUP)

CL Item

Tablespoon (TBS)

CL Item

Tablet (TAB)

CL Item

Teaspoon (TSP)

CL Item

Units (UNT)

CL Item

Unknown (U)

CL Item

Vial (VIA)

Concomitant medication Frequency

Item

Frequency

text

C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Frequency

Code List

Frequency

CL Item

3 times per week (2W)

CL Item

3 times per week (2W)

CL Item

4 times per week (4W)

CL Item

5 times per day (5D)

CL Item

5 times per week (5W)

CL Item

AC (AC)

CL Item

Q12H (2D)

CL Item

Continuous infusion (CO)

CL Item

Every 2 weeks (FO)

CL Item

Every 3 weeks (Q3W)

CL Item

Every 3 months (Q3M)

CL Item

Every other day (AD)

CL Item

QPM (1N)

CL Item

Once a month (MO)

CL Item

Once a week (WE)

CL Item

Once daily (1D)

CL Item

Once only (1S)

CL Item

PC (PC)

CL Item

PRN (PRN)

CL Item

Q2H (12D)

CL Item

Q3D (Q3D)

CL Item

Q4D (Q4D)

CL Item

Q4H (6D)

CL Item

QID (4D)

CL Item

TID (3D)

CL Item

Q12H (2D)

CL Item

QAM (1M)

CL Item

QH (24D)

CL Item

QID (4D)

CL Item

QPM (1N)

CL Item

TID (3D)

CL Item

Unknown (U)

Route of concomitant medication

Item

Route

text

C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Route of medication

Code List

Route

CL Item

Both eyes (047)

C0229118 (UMLS CUI-1)
(Comment:en)

CL Item

Epidural (008)

C0014537 (UMLS CUI-1)
(Comment:en)

CL Item

Gastrostomy tube (GT)

C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)

CL Item

Inhalation (055)

C0004048 (UMLS CUI-1)
(Comment:en)

CL Item

Injection (INJ)

C1272883 (UMLS CUI-1)
(Comment:en)

CL Item

Intra-arterial (013)

C0694634 (UMLS CUI-1)
(Comment:en)

CL Item

Intra-bursa (IBU)

C0230212 (UMLS CUI-1)
(Comment:en)

CL Item

Intralesional (026)

C1512954 (UMLS CUI-1)
(Comment:en)

CL Item

Intramuscular (030)

C0442117 (UMLS CUI-1)
(Comment:en)

CL Item

Nasal (045)

C0442118 (UMLS CUI-1)
(Comment:en)

CL Item

Intraocular (031)

CL Item

Intraosteal (IOS)

CL Item

Intraperitoneal (033)

CL Item

Intrathecal (037)

CL Item

Intrauterine (015)

CL Item

Intravenous (042)

CL Item

Nasal (045)

CL Item

Oral (048)

CL Item

Rectal (054)

CL Item

Subcutaneous (058)

CL Item

Sublingual (060)

CL Item

Topical (061)

CL Item

Transdermal (062)

CL Item

Unknown (065)

CL Item

Vaginal (067)

Concomitant Medication Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Ongoing concomitant medication

Item

Ongoing?

boolean

C2826666 (UMLS CUI [1])

Concomitant medication end date

Item

If no ongoing medication, specify end date

date

C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Concomitant Medication Primary Indication

Item

Primary Indication

text

C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])

Drug Type

Item

Drug Type

text

C0457591 (UMLS CUI [1])

Drug Type

Code List

Drug Type

CL Item

Concomitant (2)

CL Item

Treatment (T)

CL Item

Cause of SAE (1)

Relevant Medical Conditions/Risk Factors

Item Group

Relevant Medical Conditions/Risk Factors

C2347946 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)

MHx Sequence Number

Item

MHx Sequence Number

text

C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])

Specific Condition

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])

Continuing?

Item

Is medical condition continuing?

text

C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Continuing?

Code List

Is medical condition continuing?

CL Item

Yes (Y)

CL Item

No (N)

CL Item

Unknown (U)

Date of last disease occurence

Item

If no, specify date of last occurrence

date

C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Relevant Other Medical History / Risk Factors

Item

Relevant Medical History / Risk Factors not noted above

text

C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])

Relevant Diagnostic Results

Item Group

Relevant Diagnostic Results

C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)

Lab Sequence Number

Item

Lab Sequence Number

text

C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

Lab Test Name

Item

Lab Test Name

text

C0022885 (UMLS CUI [1])

Test Name

Code List

Lab Test Name

CL Item

Activated partical tromboplastin time (Activated partical tromboplastin time)

CL Item

Albumin (Albumin)

CL Item

Alkaline phosphatase (Alkaline phosphatase)

CL Item

Amylase (Amylase)

CL Item

Basophils (Basophils)

CL Item

Bicarbonate (Bicarbonate)

CL Item

Bilirubin (Bilirubin)

CL Item

Bilirubin direct (Bilirubin direct)

CL Item

Bilirubin total (Bilirubin total)

CL Item

Blood myoglobin (Blood myoglobin)

CL Item

Blood pH (Blood pH)

CL Item

Blood Pressure (Blood Pressure)

CL Item

Blood urea nitrogen (Blood urea nitrogen)

CL Item

Body temperature (Body temperature)

CL Item

Calcium (Calcium)

CL Item

CD4 Lymphocytes (CD4 Lymphocytes)

CL Item

CD8 lymphocytes (CD8 lymphocytes)

CL Item

Chloride (Chloride)

CL Item

Cholesterol total (Cholesterol total)

CL Item

C-reactive protein (C-reactive protein)

CL Item

Creatine (Creatine)

CL Item

Creatine phosphokinase (Creatine phosphokinase)

CL Item

Creatine phosphokinase MB (Creatine phosphokinase MB)

CL Item

Creatinine (Creatinine)

CL Item

Creatinine clearance (Creatinine clearance)

CL Item

Diastolic blood pressure (Diastolic blood pressure)

CL Item

Eosinophils (Eosinophils)

CL Item

Erithrocyte sedimentation rate (Erithrocyte sedimentation rate)

CL Item

Fasting blood glucose (Fasting blood glucose)

CL Item

FEV 1 (FEV 1)

CL Item

Gamma-glutamyltransferase (Gamma-glutamyltransferase)

CL Item

Glutamic-oxaloacetic transaminase (Glutamic-oxaloacetic transaminase)

CL Item

Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)

CL Item

HbA1c (HbA1c)

CL Item

HBV-DNA decreased (HBV-DNA decreased)

CL Item

HBV-DNA increased (HBV-DNA increased)

CL Item

Heart rate (Heart rate)

CL Item

Hematocrit (Hematocrit)

CL Item

Hemoglobin (Hemoglobin)

CL Item

High density lipoprotein (High density lipoprotein)

CL Item

HIV viral load (HIV viral load)

CL Item

INR (INR)

CL Item

Lactic dehydrogenase (Lactic dehydrogenase)

CL Item

Lipase (Lipase)

CL Item

Low density lipoprotein (Low density lipoprotein)

CL Item

Lymphocytes (Lymphocytes)

CL Item

Magnesium (Magnesium)

CL Item

Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)

CL Item

Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)

CL Item

Mean corpuscular volume (Mean corpuscular volume)

CL Item

Monocytes (Monocytes)

CL Item

Neutrophils (Neutrophils)

CL Item

Oxygen saturation (Oxygen saturation)

CL Item

pCO2 (pCO2)

CL Item

pH (pH)

CL Item

Phosphate (Phosphate)

CL Item

Palatelet count (Palatelet count)

CL Item

pO2 (pO2)

CL Item

Potassium (Potassium)

CL Item

Protein total (Protein total)

CL Item

Prothrombin time (Prothrombin time)

CL Item

Red blood cell count (Red blood cell count)

CL Item

Respiratory rate (Respiratory rate)

CL Item

Reticulocyte count (Reticulocyte count)

CL Item

Serum glucose (Serum glucose)

CL Item

Serum uric acid (Serum uric acid)

CL Item

Sodium (Sodium)

CL Item

Systolic blood pressure (Systolic blood pressure)

CL Item

Thrombin time (Thrombin time)

CL Item

Total lung capacity (Total lung capacity)

CL Item

Triglycerides (Triglycerides)

CL Item

Troponin (Troponin)

CL Item

Troponin I (Troponin I)

CL Item

Troponin T (Troponin T)

CL Item

Urine myoglobin (Urine myoglobin)

CL Item

Urine pH (Urine pH)

CL Item

Vital capacity (Vital capacity)

CL Item

White blood cell count (White blood cell count)

Test Date

Item

Test Date

date

C2826247 (UMLS CUI [1])

Laboratory Test Result

Item

Laboratory Test Result

text

C0587081 (UMLS CUI [1])

Laboratory Test Units

Item

Laboratory Test Units

text

C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])

Normal Low Range

Item

Normal Low Range

text

C1272773 (UMLS CUI [1])

Normal High Range

Item

Normal High Range

text

C1299400 (UMLS CUI [1])

Relevant other diagnostic laboratory results

Item

Relevant diagnostic results not noted above

text

C2347946 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Investigational Product

Item Group

Investigational Product

C0304229 (UMLS CUI-1)

event recurence after investigational product administered again

Item

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?

text

C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])

event recurence after investigational product administered again

Code List

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?

CL Item

No (N)

CL Item

Yes (Y)

CL Item

Unknown at this time (U)

CL Item

Not applicable (X)

General narrative comments

Item Group

General narrative comments

C0947611 (UMLS CUI-1)

General comment

Item

General narrative comment

text

C0947611 (UMLS CUI [1])

Administrative Data (Non clinical)

Item Group

Non clinical

C1320722 (UMLS CUI-1)

send incomplete SAE data to sponsoring company

Item

Send incomplete SAE data to GSK Safety

boolean

C1519246 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])

Receipt date by sponsoring company

Item

Receipt by GSK date

datetime

C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])

Serious Adverse Event

Item

Was the event serious?

boolean

C1519255 (UMLS CUI [1])

SAE Sequence Number

Item

SAE Sequence Number

text

C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

Version Number

Item

Version Number

text

C2985700 (UMLS CUI [1])

Case ID

Item

Case ID

text

C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

Randomisation Number

Item

Randomisation Number

text

C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

OCEANS Code

Item

OCEANS Code

text

C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])

Item

Email Flag

text

C0013849 (UMLS CUI [1])

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Versões (1)

Titular dos direitos

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DOI

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Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

SB-681323 in ALI/ARDS risk patients - NCT00996840

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