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 |
|---|---|---|---|---|---|---|---|---|
| Lead in Period: Placebo | Participants who successfully completed the baseline examination visit at the clinical site/unit, were treated with placebo for the entire duration of the lead-in period (up to 3 weeks). | 0 | None | 0 | 169 | 21 | 169 | View |
| Double-blind Treatment + Withdrawal Period: Placebo | Participants who were responders (30 percent \[%\]) or more improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) total score during the placebo run-in) or non-responders to lead-in placebo group were re-randomized to receive placebo matching to JNJ-67953964 capsules (2 placebo capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to Selective serotonin reuptake inhibitors /Serotonin and norepinephrine reuptake inhibitors (SSRI/SNRI) treatment. Participants who completed the double-blind treatment period prior to the end of Week 11 entered the withdrawal period where they were treated with placebo for 2 weeks. | 0 | None | 1 | 84 | 10 | 84 | View |
| Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | Participants who were responders (30% or more improvement on the MADRS total score during the placebo run-in were responders) or non-responders to lead-in placebo group were re-randomized to receive 10 mg JNJ-67953964 capsules (2\*5 mg JNJ-67953964 capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. Participants who completed the double-blind treatment period prior to the end of Week 11 entered the withdrawal period where they were treated with placebo for 2 weeks. | 0 | None | 0 | 85 | 23 | 85 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |