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 @ 2:01 PM
Ignite Modification Date: 2025-12-25 @ 12:46 PM
NCT ID: NCT00221195
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from time of consent to the end of the study, which totaled 15 months.
Study: NCT00221195
Study Brief: Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
On-demand Period During the on-demand period, bleeding was treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician. There were 3 subjects that never received on-demand therapy, therefore 31 subjects were assessed for AEs during this period. None None 3 31 16 31 View
Prophylaxis Period During the prophylaxis period, AICC was administered at a target dose of 85 U per kilogram (±15%) (range, 72 to 98) on 3 nonconsecutive days weekly. Bleeding episodes during the prophylaxis period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician. There were 3 subjects that never received prophylaxis therapy, therefore 31 subjects were assessed for AEs during this period. None None 4 31 17 31 View
Washout Period Bleeding episodes during the washout period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician. There were 5 subjects that never entered the washout period, therefore 31 subjects were assessed for AEs during this period. None None 4 29 14 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Surgical Procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Catheter-site Hemorrhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Catheter-site Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebral Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Subdural Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint Swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Hemorrhage NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Poor Venous Access NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Catheter-site Hemorrhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Catheter-site Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tongue Hemorrhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View