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 |
|---|---|---|---|---|---|---|---|---|
| Idelalisib | Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. 1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively. | 0 | None | 0 | 2 | 2 | 2 | View |
| Loncastuximab Tesirine | Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days). | 1 | None | 3 | 4 | 4 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dysphagia, | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Porphyria non-acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Odynophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Seborrheic keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| COVID-19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood creatinine increased, | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |