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 @ 6:30 PM
Ignite Modification Date:
2025-12-25 @ 4:00 PM
NCT ID:
NCT03114657
Description:
None
Frequency Threshold:
5
Time Frame:
Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
Study:
NCT03114657
Study Brief:
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Crenezumab | Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks. | 0 | None | 33 | 404 | 85 | 404 | View |
| Placebo | Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks. | 6 | None | 42 | 398 | 77 | 398 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| TRIFASCICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.0 | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| CELLULITIS STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| CLOSTRIDIUM DIFFICILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| ENTEROBACTER PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| LIVER ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| NEUROSYPHILIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| PHARYNGITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| PNEUMONIA INFLUENZAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| STAPHYLOCOCCAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| CLAVICLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| CRANIOCEREBRAL INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| MENISCUS INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| PUBIS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| ARTHROSCOPY | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| BONE GIANT CELL TUMOUR MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| CLEAR CELL ENDOMETRIAL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| LUNG ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| LUNG NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| AMYOTROPHIC LATERAL SCLEROSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| CEREBRAL ARTERIOSCLEROSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| ISCHAEMIC CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SPEECH DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SUBARACHNOID HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SUPERIOR SAGITTAL SINUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| AGGRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| DEPRESSIVE SYMPTOM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| SUICIDE THREAT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.0 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| INTERSTITIAL LUNG DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| CARDIAC ABLATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.0 | View |
| KNEE ARTHROPLASTY | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.0 | View |
| ARTERIOVENOUS FISTULA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| HYPERTENSIVE CRISIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| PERIPHERAL VASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| SHOCK HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |