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Informações:
Falhas:
ID
26023
Descrição
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Serious adverse events - Repeating form (Scheduled visits)
Palavras-chave
Versões (6)
- 27/09/2017 27/09/2017 -
- 04/10/2017 04/10/2017 -
- 13/10/2017 13/10/2017 -
- 23/10/2017 23/10/2017 -
- 26/12/2017 26/12/2017 -
- 28/12/2017 28/12/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de outubro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
Similar models
Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
SAE possible study endpoint
Item
1. Is event a possible study endpoint?
boolean
Death
Item
Primary adjudicated endpoints: [1] Death
boolean
Myocardial infarction
Item
Primary adjudicated endpoints: [2] Myocardial infarction
boolean
Stroke/TIA
Item
Primary adjudicated endpoints: [3] Stroke/TIA
boolean
Coronary revascularisation
Item
Other adjudicated endpoints: [4] Coronary revascularisation
boolean
Hospitalisation for unstable angina
Item
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
boolean
Hospitalisation for heart failure
Item
Other adjudicated endpoints: [8] Hospitalisation for heart failure
boolean
Limb amputation due to vascular cause
Item
Other endpoints: [7] Limb amputation due to vascular cause
boolean
Non-coronary revascularisation
Item
Other endpoints: [9] Non-coronary revascularisation
boolean
Hospitalisation for non-coronary ischaemic event
Item
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event
boolean
event to be adjudicated
Item
2. Is this an event to be adjudicated?
boolean
adjudicated event Death
Item
Primary adjudicated endpoints: [1] Death
boolean
adjudicated event Myocardial infarction
Item
Primary adjudicated endpoints: [2] Myocardial infarction
boolean
adjudicated event Stroke/TIA
Item
Primary adjudicated endpoints: [3] Stroke/TIA
boolean
adjudicated event Coronary revascularisation
Item
Other adjudicated endpoints: [4] Coronary revascularisation
boolean
adjudicated event Hospitalisation for unstable angina
Item
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
boolean
adjudicated event Hospitalisation for heart failure
Item
Other adjudicated endpoints: [8] Hospitalisation for heart failure
boolean
event non-adjudicated endpoint
Item
Is event a non-adjudicated endpoint?
boolean
Non-adjudicated endpoint Limb amputation due to vascular cause
Item
Other endpoints: [7] Limb amputation due to vascular cause
boolean
Non-adjudicated endpoint Non-coronary revascularisation
Item
Other endpoints: [9] Non-coronary revascularisation
boolean
Non-adjudicated endpoint Hospitalisation for non-coronary ischaemic event
Item
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
Occurence of endpoints
Item
4. Did any of these endpoints occur?
boolean
Occurence of death
Item
[D] Death
boolean
CL Item
Cardiovascular (1)
CL Item
Non-cardiovascular (2)
Occurence of Myocardial infarction
Item
[M] Myocardial infarction
boolean
Occurence of Hospitalisation for unstable angina
Item
[U] Hospitalisation for unstable angina
boolean
Occurence of Coronary revascularisation
Item
[R] Coronary revascularisation (any PCI or CABG)
boolean
Occurence of Stroke/TIA
Item
[1] Stroke/TIA
boolean
Hospitalisation for heart failure
Item
[2] Hospitalisation for heart failure
boolean
Hospitalisation for Non-adjudicated ischaemic event
Item
[6] Non-adjudicated ischaemic event
boolean
Hospitalisation for Limb amputation due to vascular cause
Item
[3] Limb amputation due to vascular cause
boolean
Hospitalisation for Non-coronary revascularisation
Item
[4] Non-coronary revascularisation
boolean
Hospitalisation for non-coronary ischaemic event
Item
[5] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
CL Item
Yes (1)
CL Item
No (2)
CL Item
No adjudicated event (3)
CL Item
Pending adjudication (4)
Initial report
Item
6. Initial report
boolean
Follow-up report
Item
7. Follow-up report
boolean
SAE after initiation of study medication
Item
8. Did SAE occur after initiation of study medication?
boolean
SAE Sequence Number
Item
9.a SAE Sequence Number
text
Serious Adverse Event
Item
9.b Serious Adverse Event
text
Modified term
Item
9.c Modified term
text
MedDRA synonym
Item
MedDRA synonym
text
MedDRA lower level term code
Item
MedDRA lower level term code
text
Failed coding
Item
Failed coding
text
Start Date
Item
9.d Start Date
date
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
End date
Item
9.e End date
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
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
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
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)
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)
Item
9.l Action Taken with Investigational Product(s) as a Result of the AE
text
Code List
9.l 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)
Withdrawal from study
Item
9.m Did the subject withdraw from study as a result of this AE?
boolean
AE caused by investigational product
Item
9.n Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE hours
Item
9.o Duration of AE if < 24 hours (hours)
integer
Duration of AE minutes
Item
9.o Duration of AE if < 24 hours (minutes)
integer
Time to Onset Since Last Dose hours
Item
9.p Time to Onset Since Last Dose (hours)
integer
Time to Onset Since Last Dose minutes
Item
9.p Time to Onset Since Last Dose (minutes)
integer
SAE caused by activities related to study participation
Item
9.q Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
Serious event
Item
9.r Was the event serious?
boolean
Related Investigational Product
Item
9.s Related Investigational Product
text
Serious Adverse Event Intensity changes
Item
10.a Serious Adverse Event
text
Start Date of event segment
Item
10.b Start Date of event segment
date
Start Time of event segment
Item
10.b Start Time of event segment Hr:Min (00:00-23:59)
time
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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
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)
SAE results in death
Item
[A] Results in death
boolean
SAE life-threatening
Item
[B] Is life-threatening
boolean
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
SAE congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
Other SAE
Item
[F] Other
boolean
Other SAE specification
Item
[F] Other, specify within general narrative comment
text
CM Sequence Number
Item
12.a CM Sequence Number
text
Drug name
Item
12.b Drug name
text
Modified reported term
Item
12.c Modified reported term
text
Dose
Item
12.d Dose
text
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)
CL Item
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
BID (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
At Bedtime (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
Q6H (4D)
CL Item
Q8H (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)
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Intranasal (045)
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)
Start Date
Item
12.h Start Date
date
Ongoing medication
Item
12.i Ongoing?
boolean
End date medication
Item
If no ongoing medication, specify end date
date
Primary Indication
Item
12.j Primary Indication
text
Modified reported term
Item
12.k Modified reported term
text
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
MHx Sequence Number
Item
13.a MHx Sequence Number
text
Specific Condition Name
Item
13.b Specific Condition Name
text
Modified reported term
Item
13.c Modified reported term
text
Date of onset
Item
13.d Date of onset
date
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical condition last occurence
Item
13.e If no continuing medical condition, specify date of last occurrence
date
Relevant Medical History / Risk Factors not noted above
Item
14. Relevant Medical History / Risk Factors not noted above
text
Lab Sequence Number
Item
15.a Lab Sequence Number
text
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
CL Item
Alanine Amino Transferase (Alanine aminotransferase)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Aspartate Amino Transferase (Aspartate aminotransferase)
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
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
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
Platelet count (Platelet 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
15.c Test Date
date
Test Result
Item
15.d Test Result
text
Test Units
Item
15.e Test Units
text
Normal Low Range
Item
15.f Normal Low Range
text
Normal High Range
Item
15.g Normal High Range
text
Relevant diagnostic results not noted above
Item
16. Relevant diagnostic results not noted above
text
Item
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
Code List
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
CL Item
Blinded trial medication (Blinded trial medication)
Start Date
Item
18.b Start Date
date
Stop Date
Item
18.c Stop Date
date
CL Item
Dose level 1 (Dose level 1)
CL Item
Dose level 2 (Dose level 2)
CL Item
Dose level 3 (Dose level 3)
Start Date
Item
19.b Start Date
date
Stop Date
Item
19.c Stop Date
date
CL Item
Course 1 (Course 1)
CL Item
Course 2 (Course 2)
CL Item
Course 3 (Course 3)
Start Date
Item
20.b Start Date
date
Stop Date
Item
20.c Stop Date
date
Dose
Item
20.d Dose
text
Cumulative Dose
Item
20.e Cumulative Dose
text
General narrative comments
Item
21. General narrative comments
text
incomplete SAE data GSK Safety
Item
22. [3] Incomplete SAE
boolean
Receipt by GSK date
Item
23. Receipt by GSK date
date
Receipt by GSK date
Item
23. Receipt by GSK date
time
serious SAE
Item
24. Was the event serious?
boolean
SAE Sequence Number
Item
25. SAE Sequence Number
text
Version Number
Item
26. Version Number
text
Case ID
Item
27. Case ID
text
Randomisation Number
Item
28. Randomisation Number
text
OCEANS Code
Item
29. OCEANS Code
text
Email Flag
Item
Email Flag
text