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: 2025-12-25 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT01757405
Description: None
Frequency Threshold: 5
Time Frame: 6 months (throughout study period)
Study: NCT01757405
Study Brief: Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 2: 1 x 270 Micrograms/kg rFVIIa BI Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion. None None 2 20 2 20 View
Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions. None None 2 18 4 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Head Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Limb Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Drug Ineffective NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Muscle Haemorrhage NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Drug Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Tinea Versicolour NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View