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 @ 11:55 PM
Ignite Modification Date: 2025-12-25 @ 9:51 PM
NCT ID: NCT03407651
Description: Adverse events and serious adverse events are based on the Safety Population.
Frequency Threshold: 0
Time Frame: Members of the study team recorded all reportable events with start dates occurring any time after informed consent was obtained until study completion, or discharge, for non-serious AEs and until 30 days after the last day of study participation for SAEs. The duration of the study was 52 days.
Study: NCT03407651
Study Brief: Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MarzAA IV 18 μg/kg IV infusion of 18 ug/kg MarzAA, Part 1 of study 0 None 0 10 1 10 View
MarzAA SC 30 μg/kg SC infusion of MarzAA SC 30 μg/kg, Part 1 of study 0 None 0 9 1 9 View
MarzAA 30 ug/kg SC infusion of MarzAA 30 ug/kg, Part 2 of study 1 None 1 10 8 10 View
MarzAA 60 ug/kg SC infusion of MarzAA 60 ug/kg, Part 2 of study 0 None 0 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.1 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Haemorrhagic vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View