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 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
NCT ID:
NCT03735420
Description:
Mild/Grade 1: No intervention; asymptomatic lab or radiographic findings; marginal clinical significance Moderate/Grade 2: OTC or single-physician visit; AE limited activities of daily living for \<48hrs Severe/Grade 3: AE significantly limited basic self-care but did not require initial hospitalization or prolongation of hospitalization; Not immediately life-threatening but disabling Serious/Grade 4: Life threatening Serious/Grade 5: Death
Frequency Threshold:
0
Time Frame:
8 weeks
Study:
NCT03735420
Study Brief:
Xanthohumol Metabolism and Signature
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Xanthohumol | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. | 0 | None | 0 | 16 | 14 | 16 | View |
| Placebo Oral Capsule | Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. | 0 | None | 0 | 14 | 12 | 14 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NCI CTCAEv4.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | View |
| Allergy symptoms | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAEv4.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAEv4.0 | View |
| Dry eyes and periorbital twitching | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAEv4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAEv4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAEv4.0 | View |
| Indigestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAEv4.0 | View |
| Increased thirst | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAEv4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAEv4.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAEv4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAEv4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAEv4.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAEv4.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Hyperactivity | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Shortness of breath on exertion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAEv4.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | View |
| Peripheral edema/swelling | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAEv4.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAEv4.0 | View |
| Itchy/dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAEv4.0 | View |
| Breast swelling | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAEv4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| Decreased urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAEv4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |
| General body pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAEv4.0 | View |