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 |
|---|---|---|---|---|---|---|---|---|
| Part B - 15 mg AX-158 Fed | Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast. | 0 | None | 0 | 8 | 1 | 8 | View |
| Part B - 15 mg AX-158 Fasted | Single Oral Dose of 15 mg AX-158 administered on Day 1 in a fasted state in treatment period 2. | 0 | None | 0 | 8 | 1 | 8 | View |
| Part C - 5 mg AX-158 | Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10 | 0 | None | 0 | 6 | 1 | 6 | View |
| Part C - 10 mg AX-158 | Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10 | 0 | None | 0 | 5 | 1 | 5 | View |
| Part C - 15 mg AX-158 | Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10 | 0 | None | 0 | 6 | 0 | 6 | View |
| Part C - Placebo | Denotes participants across all Part C cohorts who received matching placebo. | 0 | None | 0 | 5 | 2 | 5 | View |
| Part A - 5 mg AX-158 | Single Oral Dose of 5 mg AX-158 administered on Day 1 | 0 | None | 0 | 0 | 0 | 6 | View |
| Part A - 50 mg AX-158 | Single Oral Dose of 50 mg AX-158 administered on Day 1 | 0 | None | 0 | 6 | 1 | 6 | View |
| Part A - Placebo | Denotes participants across all Part A cohorts who received matching placebo. | 0 | None | 0 | 9 | 1 | 9 | View |
| Part A - 25 mg AX-158 | Single Oral Dose of 25 mg AX-158 administered on Day 1 | 0 | None | 0 | 4 | 0 | 4 | View |
| Part A - 10 mg AX-158 | Single Oral Dose of 10 mg AX-158 administered on Day 1 | 0 | None | 0 | 5 | 0 | 5 | View |
| Part A - 15 mg AX-158 | Single Oral Dose of 15 mg AX-158 administered on Day 1 | 0 | None | 0 | 4 | 0 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (24.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.1) | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.1) | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |