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: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-26 @ 10:59 AM
NCT ID: NCT00866606
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 0
Time Frame: From screening until 30 days after the last visit (Month 6/Final/Early Termination visit
Study: NCT00866606
Study Brief: Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BeneFactor IX (BeneFIX) Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital). None None 2 35 19 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hemophilia B with anti factor IX NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint Sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hematocrit abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hemoglobin abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Red blood cell count abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Synovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View