Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT00089895
Description:
None
Frequency Threshold:
5
Time Frame:
Through hospital discharge or 120 hours after randomization, whichever occurred first.
Study:
NCT00089895
Study Brief:
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Eptifibatide | Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. | None | None | 66 | 4686 | 0 | 4686 | View |
| Placebo | Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. | None | None | 60 | 4643 | 0 | 4643 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.1 | View |
| MICROCYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.1 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| MIDDLE EAR INFLAMMATION | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 11.1 | View |
| ADRENOCORTICAL INSUFFICIENCY ACUTE | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 11.1 | View |
| OPHTHALMOPLEGIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| RETINAL ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| DIVERTICULUM INTESTINAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| GASTRIC PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| GASTRIC ULCER HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| INTESTINAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| OESOPHAGEAL ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| IMPLANT SITE EFFUSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| MULTI-ORGAN FAILURE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| CHOLANGITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| LIVER DISORDER | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| ABDOMINAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| HEPATITIS A | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| PERIRECTAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| PULMONARY TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| MEDICATION ERROR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.1 | View |
| INTERNATIONAL NORMALISED RATIO DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| BLADDER CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| GASTROINTESTINAL TRACT ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| HEPATIC NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| LUNG NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| PARKINSONISM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| VASCULAR ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| IGA NEPHROPATHY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| NEPHRITIS INTERSTITIAL | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| NEPHROPATHY TOXIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| NEPHROSCLEROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| RENAL FAILURE CHRONIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| RENAL INFARCT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| ANOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| BRONCHOSPASM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| PLEURAL FISTULA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| PULMONARY CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| RESPIRATORY DISTRESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| AORTIC DISSECTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| CIRCULATORY COLLAPSE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| PERIPHERAL EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
Other Events(If Any):