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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT01758432
Description: Only subjects who received at least one dose of study drug were included in the safety analysis.
Frequency Threshold: 3
Time Frame: ~7 weeks
Study: NCT01758432
Study Brief: Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Module 1 Placebo Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion. None None 0 18 14 18 View
Module 1 ( 90 mg) 90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min) None None 0 6 3 6 View
Module 1 (210 mg) 210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min) 420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min) None None 0 6 3 6 View
Module 1 (420 mg) 420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min) None None 0 6 5 6 View
Module 1 (420 mg Bolus + 180 mg Infusion) 420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\] None None 0 6 4 6 View
Module 1 (420 mg Bolus + 180 mg Bolus) 420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\] None None 0 6 2 6 View
Module 1 (420 mg Bolus + 480 mg Infusion) 420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\] None None 0 6 3 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Ocular hyperaemmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Vessel puncture site paraesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Vessel puncture site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Heat rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View