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 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
NCT ID:
NCT04164732
Description:
None
Frequency Threshold:
4.99
Time Frame:
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
Study:
NCT04164732
Study Brief:
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Run-In Period Placebo | All patients received oral (p.o.) placebo b.i.d. for 2 weeks | 0 | None | 0 | 46 | 4 | 46 | View |
| Run-In LCZ696 50 mg | All patients received 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks | 0 | None | 0 | 43 | 4 | 43 | View |
| Double-blind Period Placebo | Patients in the double-blind period treated with placebo | 0 | None | 0 | 20 | 10 | 20 | View |
| Double-blind Period LCZ696 50 mg | Patients in the double-blind period treated with LCZ696 50mg | 0 | None | 0 | 1 | 1 | 1 | View |
| Double-blind Period LCZ696 100 mg | Patients in the double-blind period treated with LCZ696 100mg | 0 | None | 1 | 20 | 6 | 20 | View |
| Double-blind Period LCZ696 200 mg | Patients in the double-blind period treated with LCZ696 200mg | 0 | None | 2 | 17 | 7 | 17 | View |
| Double-blind Period LCZ696 | All patients in the double-blind period treated with LCZ696 | 0 | None | 3 | 20 | 12 | 20 | View |
| Total | Total | 0 | None | 3 | 46 | 26 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Bundle branch block right | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (26.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Gastric disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Gastrointestinal sounds abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Foreign body in eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Abnormal loss of weight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |