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
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
NCT ID:
NCT01490502
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 2 years
Study:
NCT01490502
Study Brief:
Vitamin D Supplementation in Multiple Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High-dose Vitamin D3 | Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). | 0 | None | 11 | 83 | 63 | 83 | View |
| Low-dose Vitamin D3 | Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). | 0 | None | 11 | 82 | 66 | 82 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Unplanned pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Planned hospitalization for elective procedure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Unplanned hospitalization | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Planned hospitalization for elective procedure | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Planned hospitalization for elective procedure | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anxiety / worsening anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sore throat (+/- streptococcal infection) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Numbness or tingling | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache / worsened headache / migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue / increased fatigue | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Joint pain or swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Depression / increased depression / severe depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Abdominal pain / cramp / discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Limb pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urinary dysfunction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dizziness / increased dizziness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Spasm / cramp (non-abdominal) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |