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 II (Venofer 500mg X 2 Doses) | A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7. | None | None | 0 | 6 | 4 | 6 | View |
| Cohort III (Venofer 500mg x 2 Doses) | A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours. | None | None | 1 | 8 | 5 | 8 | View |
| Cohort I (Venofer 500mg x 1 Dose) | Single 500 mg infusion of Venofer over 4 hours. | None | None | 0 | 7 | 5 | 7 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heart rate irregular | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.0) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.0) | View |
| Diarrhea NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.0) | View |
| Hypotension NOS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.0) | View |
| Injection site reaction NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (6.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.0) | View |
| Oedema NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.0) | View |
| Phlebitis NOS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.0) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.0) | View |
| Rhinitis allergic NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) | View |
| Sweating increased | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.0) | View |
| Umbilical hernia NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.0) | View |
| Urticaria NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (6.0) | View |
| Vomiting NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.0) | View |