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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of placebo 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks. | None | None | 1 | 1 | 0 | 1 | View |
| orBec | orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of orBec 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks. | None | None | 0 | 1 | 0 | 1 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| biliary strictures | None | Hepatobiliary disorders | None | View |
| fungal pneumonia | None | Infections and infestations | None | View |
| shortness of breath | None | Respiratory, thoracic and mediastinal disorders | None | View |
| pulmonary emboli | None | Vascular disorders | None | View |
| intractable pain | None | General disorders | None | View |