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 |
|---|---|---|---|---|---|---|---|---|
| Controlled Phase- Icatibant (Randomized Subjects ) | Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase. | None | None | 0 | 27 | 12 | 27 | View |
| Controlled Phase- Placebo (Randomized Subjects | Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase. | None | None | 0 | 29 | 19 | 29 | View |
| Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase. | None | None | 1 | 8 | 6 | 8 | View |
| Open Label Extension Phase- Icatibant (Previously Randomized) | Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase. | None | None | 3 | 49 | 39 | 49 | View |
| Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack) | This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase. | None | None | 0 | 3 | 3 | 3 | View |
| Open Label Extension Phase(Untreated Patients at the Baseline) | This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing. | None | None | 0 | 20 | 17 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Headache/Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Hereditary angioedema | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 8.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Blood Creatine Phosphokinase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |