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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fosaprepitant 150 mg | A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1. | None | None | 0 | 8 | 5 | 8 | View |
| Aprepitant 165 mg | A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1. | None | None | 0 | 8 | 8 | 8 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 13.0 | View |
| Fatigue | None | General disorders | MedDRA 13.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 13.0 | View |
| Dizziness postural | None | Nervous system disorders | MedDRA 13.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Hiccups | None | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Flushing | None | Vascular disorders | MedDRA 13.0 | View |
| Vision blurred | None | Eye disorders | MedDRA 13.0 | View |
| Visual impairment | None | Eye disorders | MedDRA 13.0 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 13.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 13.0 | View |
| Gastroesophageal reflux disease | None | Gastrointestinal disorders | MedDRA 13.0 | View |
| Influenza like illness | None | General disorders | MedDRA 13.0 | View |
| Neutrophil count decreased | None | Investigations | MedDRA 13.0 | View |
| Positron emission tomogram abnormal | None | Investigations | MedDRA 13.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 13.0 | View |
| Headache | None | Nervous system disorders | MedDRA 13.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 13.0 | View |
| Dry throat | None | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Acne | None | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |