Table 7.
Characteristic | During infusion | After infusion | |||||
Day of event1 | 1 | 1 | 7 | 8 | 10 | UD | UD |
Bleeding event | |||||||
ICH | No | No | No | Yes | No | Yes | Yes |
Fatal | No | No | No | Yes | No | Yes | No |
DrotAA related2 | No | No | No | Yes | No | No | No |
Disease category | |||||||
PF | Yes | Yes | Yes | Yes | Yes | No | Yes |
MEN | No | Yes | No | No | No | Yes | No |
MD | Yes | Yes | Yes | Yes | Yes | Yes | No |
Baseline characteristics | |||||||
Protein C level (%) | 36 | - | 16 | 41 | - | 34 | - |
Platelet count | 26 | 23 | 33 | 30 | 68 | 71 | 14 |
APTT (s) | 68 | 165 | 121 | 220 | 73 | 111 | - |
PT (s) | 23 | 38 | 22 | - | - | 17 | 16 |
Organ failure | 3 | 4 | 3 | 4 | 1 | - | - |
1Day 0 is defined as the calendar day on which DrotAA treatment began; 2This denotes whether or not the investigator considered the bleeding event to be related to treatment with DrotAA. APTT, activated partial thromboplastin time; BL, baseline; DrotAA, drotrecogin alfa (activated); ICH, intracranial hemorrhage; PT, prothrombin time; UD, unknown day after infusion. A dash indicates missing data.