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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
NCT ID:
NCT04770220
Description:
None
Frequency Threshold:
5
Time Frame:
All AEs (deaths, Serious Adverse Events, Other Adverse Events) were recorded for up to 95 weeks (13 weeks screening + 78-week treatment + 4 weeks follow-up). All AEs were collected from ICF signing at screening through Safety Follow-up Visit 4 weeks after last efficacy visit at week 78. Medical conditions present at screening were captured as medical history. However, if a condition deteriorated, it was recorded as an AE.
Study:
NCT04770220
Study Brief:
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study Placebo Comparator: Placebo: Placebo tablet BID | 0 | None | 13 | 162 | 94 | 162 | View |
| ALZ-801 | ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID. Experimental: ALZ-801: ALZ-801 tablet 265 mg BID | 0 | None | 15 | 163 | 104 | 163 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Coronary Artery Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Myocardial Injury | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 26.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 26.1 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 26.1 | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.1 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 26.1 | View |
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 26.1 | View |
| Gallbladder necrosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 26.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Cholecystitis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Pyelonephritis Acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Ankle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Bladder Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Incarcerated Incisional Hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Pelvic Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Blood Calcium Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 26.1 | View |
| Blood Potassium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 26.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 26.1 | View |
| Adenocarcinoma of colon | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | View |
| Glioblastoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | View |
| Malignant Melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | View |
| Thyroid Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Paranoia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.1 | View |
| Psychotic Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.1 | View |
| Renal Colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 26.1 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 26.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.1 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 26.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |
| Cerebral Microhaemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.1 | View |
| Amyloid related imaging abnormality - microhaemorrhages and heamosiderin deposits | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 26.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 26.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 26.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 26.1 | View |