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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT03417102
Description:
TEAEs: any AE with onset date after first dose of fitusiran in fitusiran prophylaxis arm or after Day 1 visit in the BPA on-demand arm. Analysis done on safety analysis set. Three participants who were treated with fitusiran but not randomized as per protocol addendum for China, were included in safety analysis for the fitusiran prophylaxis arm.
Frequency Threshold:
5
Time Frame:
AE data were collected from Baseline (Day 1) up to 15 months (i.e., 9 months treatment period + 6-months follow-up).
Study:
NCT03417102
Study Brief:
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients 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 |
|---|---|---|---|---|---|---|---|---|
| Bypassing Agents (BPA) On-demand | Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months. | 0 | None | 5 | 19 | 8 | 19 | View |
| Fitusiran 80 mg Prophylaxis | Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months. | 0 | None | 7 | 41 | 32 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA24.0 | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA24.0 | View |
| Traumatic Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA24.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA24.0 | View |
| Spinal Vascular Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA24.0 | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA24.0 | View |
| Asymptomatic Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Haematoma Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Subclavian Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA24.0 | View |
| Biliary Colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA24.0 | View |
| Muscle Haemorrhage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA24.0 | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Vascular Device Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA24.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA24.0 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA24.0 | View |
| Cholecystitis Chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Fibrin D Dimer Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Gamma-Glutamyltransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Prothrombin Fragment 1.2 Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Transaminases Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA24.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA24.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA24.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA24.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA24.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA24.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA24.0 | View |
| Asymptomatic Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA24.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA24.0 | View |