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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT01913405
Description: Adverse Events (AEs) were recorded throughout the entire study period from screening to completion/termination. AEs that occurred during or after study treatment are summarized here, AEs that occurred prior to study treatment were listed separately and are not included.
Frequency Threshold: 0
Time Frame: Throughout the entire study period (2 years and 9 months). For each participant the duration of treatment and therefore the entire study period depended on the nature of each participants invasive procedure (ranged from 43 days to 162 days).
Study: NCT01913405
Study Brief: Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BAX855 Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed. 0 None 2 22 8 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetic gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 19.1 View
Oesophageal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 19.1 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peritonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 19.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 19.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 19.1 View
Hyperacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Meddra 19.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 19.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 19.1 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations Meddra 19.1 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 19.1 View
Procedural hypotension NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 19.1 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 19.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 19.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 19.1 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 19.1 View