Table 3.
Rates of Adverse Events, According to Study Group.*
| Serious Adverse Event | Extended-Release Dipyridamole plus Aspirin (N = 321) | Placebo (N = 328) | Hazard Ratio for Event Rate (95% CI)† | ||||
|---|---|---|---|---|---|---|---|
| No. of Patients (%) | No. of Events | Event Rate | No. of Patients (%) | No. of Events | Event Rate | ||
| no./patient-yr | no./patient-yr | ||||||
|
| |||||||
| Any | 175 (55) | 331 | 1.19 | 174 (53) | 360 | 1.47 | 0.93 (0.75–1.15) |
|
| |||||||
| Bleeding‡ | 37 (12) | 42 | 0.20 | 40 (12) | 50 | 0.24 | 0.86 (0.55–1.35) |
|
| |||||||
| Intermediate or minor | 23 (7) | 24 | 0.12 | 26 (8) | 33 | 0.15 | |
|
| |||||||
| Major | 6 (2) | 7 | 0.03 | 9 (3) | 9 | 0.05 | |
|
| |||||||
| Life-threatening | 9 (3) | 9 | 0.05 | 8 (2) | 8 | 0.05 | |
|
| |||||||
| Fatal | 2 (1) | 2 | 0.01 | 0 | 0 | 0.00 | |
|
| |||||||
| Hospitalization | 172 (54) | 280 | 1.17 | 171 (52) | 301 | 1.44 | 0.93 (0.75–1.15) |
|
| |||||||
| For ischemic heart disease | 19 (6) | 23 | 0.10 | 18 (5) | 23 | 0.11 | |
|
| |||||||
| For congestive heart failure | 19 (6) | 25 | 0.10 | 20 (6) | 31 | 0.12 | |
|
| |||||||
| For arrhythmia | 8 (2) | 9 | 0.04 | 10 (3) | 12 | 0.06 | |
|
| |||||||
| For cerebrovascular disease | 5 (2) | 6 | 0.03 | 3 (1) | 6 | 0.02 | |
|
| |||||||
| For peripheral vascular disease | 13 (4) | 15 | 0.07 | 6 (2) | 7 | 0.04 | |
|
| |||||||
| For event at site of study graft | 62 (19) | 71 | 0.34 | 48 (15) | 52 | 0.29 | |
|
| |||||||
| For event at other vascular access site | 14 (4) | 14 | 0.07 | 15 (5) | 16 | 0.09 | |
|
| |||||||
| Death | 17 (5) | 17 | 0.09 | 13 (4) | 13 | 0.07 | 1.20 (0.58–2.47) |
A patient-level analysis was used for event rates, which were calculated as the ratio of the number of first serious adverse event of each type to the total number of patient-years of follow-up until the first serious adverse event of this type occurred in each patient.
P>0.15 for each type of serious adverse event.
Intermediate or minor bleeding events were those that were not classified as major, life-threatening, or fatal. Major bleeding was defined as confirmed retroperitoneal, intraarticular, intraocular, or intracranial bleeding or any bleeding that led to a drop in the hemoglobin level of 2 g per deciliter and required hospitalization or transfusion. Life-threatening bleeding was defined as any bleeding that led to a drop in the hemoglobin level of 5 g per deciliter or more, required emergency surgical intervention, caused a symptomatic intracranial hemorrhage, or required a transfusion of more than 4 units of packed red cells or whole blood. Fatal bleeding was any bleeding that caused or precipitated death.