Trial Outcomes & Findings for EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED) (NCT NCT00089895)
NCT ID: NCT00089895
Last Updated: 2024-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9406 participants
Primary outcome timeframe
96 hours after randomization
Results posted on
2024-05-17
Participant Flow
Patients in both treatment groups who were undergoing PCI could receive unblinded eptifibatide provisionally immediately before or during percutaneous coronary intervention (PCI) at the discretion of the investigator.
Participant milestones
| Measure |
Eptifibatide
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
|---|---|---|
|
Overall Study
STARTED
|
4722
|
4684
|
|
Overall Study
COMPLETED
|
4687
|
4642
|
|
Overall Study
NOT COMPLETED
|
35
|
42
|
Reasons for withdrawal
| Measure |
Eptifibatide
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
|---|---|---|
|
Overall Study
Consent Withdrawn
|
11
|
14
|
|
Overall Study
Technical reason
|
7
|
2
|
|
Overall Study
Surgery
|
0
|
1
|
|
Overall Study
Bleeding
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
7
|
|
Overall Study
Exclusion criteria met
|
6
|
6
|
|
Overall Study
Not otherwise specified
|
4
|
8
|
|
Overall Study
Missing
|
4
|
2
|
Baseline Characteristics
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Eptifibatide
n=4722 Participants
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
n=4684 Participants
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Total
n=9406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1513 Participants
n=5 Participants
|
1462 Participants
n=7 Participants
|
2975 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3209 Participants
n=5 Participants
|
3222 Participants
n=7 Participants
|
6431 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 96 hours after randomizationPopulation: Intent to treat population
Outcome measures
| Measure |
Eptifibatide
n=4722 Participants
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
n=4684 Participants
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
|---|---|---|
|
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
|
9.3 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days after randomizationPopulation: Intent to treat population
Outcome measures
| Measure |
Eptifibatide
n=4722 Participants
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
n=4684 Participants
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
|---|---|---|
|
Incidence of the Composite of Death/MI.
|
11.2 percentage of participants
|
12.3 percentage of participants
|
Adverse Events
Eptifibatide
Serious events: 66 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 60 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eptifibatide
n=4686 participants at risk
Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
Placebo
n=4643 participants at risk
Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
|
|---|---|---|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
RENAL INFARCT
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
ANOXIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
NEPHROPATHY TOXIC
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
NEPHROSCLEROSIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.13%
6/4686 • Number of events 6 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.09%
4/4643 • Number of events 4 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.13%
6/4686 • Number of events 6 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.11%
5/4643 • Number of events 5 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Ear and labyrinth disorders
MIDDLE EAR INFLAMMATION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Endocrine disorders
ADRENOCORTICAL INSUFFICIENCY ACUTE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Eye disorders
OPHTHALMOPLEGIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Eye disorders
RETINAL ARTERY OCCLUSION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
General disorders
ASTHENIA
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
General disorders
IMPLANT SITE EFFUSION
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
General disorders
INJECTION SITE PAIN
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
General disorders
PYREXIA
|
0.06%
3/4686 • Number of events 3 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.04%
2/4643 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
CELLULITIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
GASTROENTERITIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
HEPATITIS A
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
INFECTION
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
LUNG INFECTION
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
PNEUMONIA
|
0.11%
5/4686 • Number of events 5 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.17%
8/4643 • Number of events 8 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
SEPSIS
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.06%
3/4643 • Number of events 3 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Infections and infestations
UROSEPSIS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.09%
4/4643 • Number of events 4 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO DECREASED
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL TRACT ADENOMA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
PARKINSONISM
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
SYNCOPE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Nervous system disorders
VASCULAR ENCEPHALOPATHY
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.04%
2/4643 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
IGA NEPHROPATHY
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Renal and urinary disorders
NEPHRITIS INTERSTITIAL
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.04%
2/4686 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL FISTULA
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.04%
2/4643 • Number of events 2 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.15%
7/4686 • Number of events 7 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.13%
6/4643 • Number of events 6 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/4686 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.02%
1/4643 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.02%
1/4686 • Number of events 1 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
0.00%
0/4643 • Through hospital discharge or 120 hours after randomization, whichever occurred first.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60