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 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
NCT ID:
NCT00357656
Description:
None
Frequency Threshold:
5
Time Frame:
Throughout the study period. Overall: 9 years and 6 months. Per participant: 9-26 weeks.
Study:
NCT00357656
Study Brief:
Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bolus Infusion | All participants who were randomized to receive bolus infusion (BI) of ADVATE (rAHF-PFM). At total of 31 participants were randomized and received at least one ADVATE (rAHF-PFM) dose. | None | None | 3 | 31 | 22 | 31 | View |
| Continuous Infusion | All participants who were randomized to receive continuous infusion (CI) of ADVATE (rAHF-PFM). At total of 32 participants were randomized and received at least one ADVATE (rAHF-PFM) dose. | None | None | 6 | 32 | 20 | 32 | View |
| Not Assigned Participants | All participants who were not assigned to either bolus infusion or continuous infusion but received at least one ADVATE (rAHF-PFM) dose during pharmacokinetic evaluation. A total of 9 participants received only the pharmacokinetic infusion and were not randomized. | None | None | 1 | 9 | 2 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Factor VIII inhibition | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Febrile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pseudomembranous colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Hemarthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Muscle hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Adenoma benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Muscle Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Anaemia postoperative | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Haemarthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |