Details of events occurred during the treatment period (up to 90 ± 3 days)
| Sex . | Age (y) . | Type of event . | Event time (d) . | Event details . |
|---|---|---|---|---|
| F | 64 | CRNMB | 10 | Hematuria, rivaroxaban dose reduced |
| F | 55 | SVT recurrence* | 10 | Symptomatic thrombosis of superior mesenteric vein and left renal vein in metastatic adenocarcinoma of the biliary tract; switched to LMWH |
| F | 54 | CRNMB† | 14 | Rectorrhagia in adenocarcinoma of the rectum with intestinal stoma; rivaroxaban withheld for 2 d |
| F | 55 | Death (non–SVT related)* | 27 | Pneumonia and septic shock in progression of metastatic adenocarcinoma of the biliary tract |
| M | 52 | SVT recurrence | 37 | Symptomatic unprovoked thrombosis of distal portal vein branches; switched to LMWH |
| F | 76 | MB | 51 | Melena with severe anemia (Hb drop ≥2 g/dL) in squamous cell carcinoma of the distal esophagus; required hospitalization and red blood cells transfusion; anticoagulation was stopped |
| F | 54 | CRNMB† | 57 | Another episode of rectorrhagia in adenocarcinoma of the rectum with intestinal stoma; rivaroxaban withheld for 2 d |
| F | 23 | CRNMB | 75 | Menorrhagia with patient discomfort; rivaroxaban was continued |
| M | 61 | MB | 85 | Melena with severe anemia (Hb drop ≥2 g/dL) in reflux esophagitis grade IV and suspected esophageal varices; required hospitalization; anticoagulation was stopped for a few days and then patient was switched to fondaparinux |
| Sex . | Age (y) . | Type of event . | Event time (d) . | Event details . |
|---|---|---|---|---|
| F | 64 | CRNMB | 10 | Hematuria, rivaroxaban dose reduced |
| F | 55 | SVT recurrence* | 10 | Symptomatic thrombosis of superior mesenteric vein and left renal vein in metastatic adenocarcinoma of the biliary tract; switched to LMWH |
| F | 54 | CRNMB† | 14 | Rectorrhagia in adenocarcinoma of the rectum with intestinal stoma; rivaroxaban withheld for 2 d |
| F | 55 | Death (non–SVT related)* | 27 | Pneumonia and septic shock in progression of metastatic adenocarcinoma of the biliary tract |
| M | 52 | SVT recurrence | 37 | Symptomatic unprovoked thrombosis of distal portal vein branches; switched to LMWH |
| F | 76 | MB | 51 | Melena with severe anemia (Hb drop ≥2 g/dL) in squamous cell carcinoma of the distal esophagus; required hospitalization and red blood cells transfusion; anticoagulation was stopped |
| F | 54 | CRNMB† | 57 | Another episode of rectorrhagia in adenocarcinoma of the rectum with intestinal stoma; rivaroxaban withheld for 2 d |
| F | 23 | CRNMB | 75 | Menorrhagia with patient discomfort; rivaroxaban was continued |
| M | 61 | MB | 85 | Melena with severe anemia (Hb drop ≥2 g/dL) in reflux esophagitis grade IV and suspected esophageal varices; required hospitalization; anticoagulation was stopped for a few days and then patient was switched to fondaparinux |
Day 0 was considered as the day when rivaroxaban was started.
Two patients had 2 events each (identified with * and †).
CRNMB, clinically relevant nonmajor bleeding; MB, major bleeding.