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 @ 6:58 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT03330457
Description: AEs, both serious and non-serious, occurring between signing informed consent and through the Termination Visit will be recorded on the eCRFs. All AEs/SAEs should be monitored until they are resolved, are not expected to improve further, or are determined to be due to a stable or chronic condition or intercurrent illness. Any AE/SAE that occurs with an onset date \> 30 days after study completion and that the Investigator considers to be related to study medication, must be reported to Portola.
Frequency Threshold: 5
Time Frame: Study day 1 to 48(+3)
Study: NCT03330457
Study Brief: A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
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 1 Bertrixaban/Andexanet Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days None None 0 6 1 6 View
Cohort 1 Bertrixaban/Placebo Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days None None 0 3 0 3 View
Cohort 2 Bertrixaban/Andexanet Andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban None None 0 6 2 6 View
Cohort 2 Bertrixaban/Placebo Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban None None 0 3 0 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vessel Puncture Site Haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View