Adverse Events Module

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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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT02195232
Description: All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
Frequency Threshold: 0
Time Frame: All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
Study: NCT02195232
Study Brief: Cancer Associated Thrombosis and Isoquercetin (CATIQ)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort B (Isoquercetin 1000 mg) Cohort B: Patients will receive isoquercetin 1000 mg once daily (4 capsules) for 28 days. Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days. 0 None 0 29 3 29 View
Cohort A (Isoquercetin 500 mg) Cohort A: Patients will receive isoquercetin 500 mg once daily (2 capsules) for 28 days. Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days. 0 None 0 28 11 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE) version 4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE) version 4.03 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE) version 4.03 View
Gastroesophageal reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE) version 4.03 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE) version 4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE) version 4.03 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE) version 4.03 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE) version 4.03 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE) version 4.03 View