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 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
NCT ID:
NCT01507051
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01507051
Study Brief:
Switching Study From Warfarin to Rivaroxaban
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RG1: Warfarin Followed by Rivaroxaban | All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section. | None | None | 0 | 28 | 14 | 28 | View |
| RG2: Warfarin Followed by Placebo | All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section. | None | None | 0 | 28 | 12 | 28 | View |
| RG3: Rivaroxaban | All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section. | None | None | 0 | 28 | 10 | 28 | View |
| RG4: Warfarin Alone | All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section. | None | None | 0 | 63 | 21 | 63 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Eructation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Gingival bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Lip dry | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Tongue ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Application site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Injection site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Febrile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.1) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Blood amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Urine output increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Muscle tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.1) | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.1) | View |
| Spontaneous penile erection | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (12.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.1) | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.1) | View |
| Tooth fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.1) | View |