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 |
|---|---|---|---|---|---|---|---|---|
| Sprix/Placebo | Sprix 31.5 mg single dose nasal spray and Placebo SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack. Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray. The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%). | None | None | 0 | 52 | 43 | 52 | View |
| Sumatriptan/Placebo | Sumatriptan 20 mg single dose nasal spray and placebo Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack. Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray. For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%). | None | None | 0 | 50 | 39 | 50 | View |
| SRIX Placebo/Sumatriptan Placebo | single dose SPRIX placebo, single dose Sumatriptan placebo Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray. The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%). | None | None | 0 | 50 | 11 | 50 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| burning of throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedWatch | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedWatch | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedWatch | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedWatch | View |
| mild burning of nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedWatch | View |
| moderate burning of nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedWatch | View |
| severe burning of nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedWatch | View |
| mild unusual taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedWatch | View |
| moderate unusual taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedWatch | View |
| severe unusual taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedWatch | View |
| nasal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedWatch | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedWatch | View |