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 |
|---|---|---|---|---|---|---|---|---|
| Cohort A | 2 to 7% of BSA treated BID with INCB018424 1.5% cream | 0 | None | 0 | 5 | 2 | 5 | View |
| Cohort B | 8 to 13% of BSA treated BID with INCB018424 1.5% cream BID | 0 | None | 0 | 5 | 4 | 5 | View |
| Cohort C | 14 to 20% of BSA treated QD with INCB018424 1.5% cream QD | 0 | None | 1 | 5 | 2 | 5 | View |
| Cohort D | 14-20% of BSA with INCB018424 1.0% cream BID | 0 | None | 0 | 5 | 1 | 5 | View |
| Cohort E | 14 to 20% of BSA treated BID with INCB018424 1.5% cream BID | 0 | None | 0 | 5 | 2 | 5 | View |
| Total | Total | 0 | None | 1 | 25 | 11 | 25 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Schizophrenia, paranoid type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Reticulocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.1 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |