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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
NCT ID:
NCT00096356
Description:
One month past the end of treatment
Frequency Threshold:
5
Time Frame:
28 weeks
Study:
NCT00096356
Study Brief:
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day. | None | None | 22 | 100 | 89 | 100 | View |
| Arm 2 - Placebo & Vitamin E | Placebo-Vitamin E 100 mg/day in 3 doses | None | None | 15 | 93 | 84 | 93 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANC | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| WBC | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| L vent sy d | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| abd pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| hot flashes | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| allergic reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| tachycardia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| alopecia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| heartburn | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| hot flashes | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| infection | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| irritability | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| mucositis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| neuropathy | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |