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 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
NCT ID:
NCT02846532
Description:
The safety population consisted of all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to 12 months
Study:
NCT02846532
Study Brief:
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \[mg/ml\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \[\<\] 8 kilograms \[kg\] participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg; and 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | 0 | None | 6 | 12 | 11 | 12 | View |
| Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | 0 | None | 19 | 64 | 48 | 64 | View |
| Aspirin (Part B) | Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months. | 0 | None | 8 | 34 | 26 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Supraventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Periorbital Oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Swelling Face | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Stoma Site Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Vaccination Site Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Wound Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Stoma Site Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Investigation | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Partial Seizures with Secondary Generalisation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Chylothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Shock Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Traumatic Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Increased Tendency to Bruise | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gingival Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Tooth Loss | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Otitis Media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pharyngitis Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Wound Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Catarrh | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Chylothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dermatitis Diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |