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 |
|---|---|---|---|---|---|---|---|---|
| Wait List Control | Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter. | None | None | 1 | 10 | 5 | 10 | View |
| Immediate Intervention Group | Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up. iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter. | None | None | 1 | 9 | 7 | 9 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | None | View |
| Feeling hot | None | General disorders | None | View |
| Infusion site bruising | None | General disorders | None | View |
| Spinal Pain | None | General disorders | None | View |
| Arthropod sting | None | Injury, poisoning and procedural complications | None | View |
| Liver function test abnormal | None | Investigations | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Orthostatic hypotension | None | Vascular disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Joint swelling | None | Musculoskeletal and connective tissue disorders | None | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Sneezing | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Contusion | None | Injury, poisoning and procedural complications | None | View |
| Skin hyperpigmentation | None | Skin and subcutaneous tissue disorders | None | View |
| Urinary tract infecction | None | Infections and infestations | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Gastrointestinal infection | None | Infections and infestations | None | View |