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 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT04313634
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse Events were collected from baseline to end of study, approximately 20 weeks
Study:
NCT04313634
Study Brief:
Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dasatinib Plus Quercetin Treatment Goup | Subjects received Dasatinib (D; 100 mg for two days) plus Quercetin (Q; 1000 mg total daily) for three consecutive days taken orally on an intermittent schedule (starting every 28 days) with no-therapy periods in between dosing regimens, repeated every 28 days over 20 weeks, resulted in five total dosing periods throughout the entire intervention Dasatinib: Dasatinib will be supplied as 100 mg tablet white to off-white, biconvex, oval, film- coated Quercetin: Quercetin will be supplied as quercetin phytosome (sophora japonica concentrate (leaf) / phosphatidylcholine complex from Sunflower) 250 mg | 0 | None | 0 | 30 | 23 | 30 | View |
| Fisetin Treatment Group | Subjects received Fisetin (F; \~20 mg/kg/day for three consecutive days) taken orally on an intermittent schedule (starting every 28 days) with no-therapy periods in between dosing regimens, repeated every 28 days over 20 weeks, resulted in five total dosing periods throughout the entire intervention Fisetin: Fisetin will be supplied in 100 mg capsules to be administered orally | 0 | None | 1 | 14 | 12 | 14 | View |
| Untreated Control Group | Subjects did not receive any intervention | 0 | None | 0 | 30 | 5 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Covid | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory, thoracic and mediastinal disorders - other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Metabolism and nutrition disorders - other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cardiac disorders - other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin and subcutaneous tissue disorders - other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Renal and urinary disorders - other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Cataract surgery | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |