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 |
|---|---|---|---|---|---|---|---|---|
| Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg | On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours). | 0 | None | 0 | 12 | 1 | 12 | View |
| Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg | On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours). | 0 | None | 0 | 12 | 4 | 12 | View |
| Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg | On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours). | 0 | None | 0 | 12 | 3 | 12 | View |
| Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg | On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours). | 0 | None | 0 | 12 | 0 | 12 | View |
| Nirmatrelvir (SDD Suspension) 300 mg | On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours). | 0 | None | 0 | 12 | 1 | 12 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.0 | View |