Table 4

Severe, life-threatening, or fatal* bleeding events reported in patients treated with romiplostim for up to 156 weeks

Patient no.EventDay event startedPlatelet count, ×109/L†Platelet response‡
6130 Gastrointestinal hemorrhage 4 8 No 
6130 Melena 4 8 No 
1131 Gingival bleeding 8 4 No 
0551 Epistaxis 17 6 Yes 
1230 Menorrhagia 46 14 Yes 
5730 Upper gastrointestinal hemorrhage 47 10 Yes 
1656 Conjunctival hemorrhage 49 89 Yes 
1633 Petechiae 71 5 Yes 
0130 Epistaxis 74 10 Yes 
5330 Hematoma (chest cavity) 86 3 Yes 
0130 Gastric ulcer hemorrhage 130 12 Yes 
0123 Vaginal hemorrhage 248 9 Yes 
0302 Purpura 395 4 Yes 
1623 Oral mucosal petechiae 531 5 Yes 
Patient no.EventDay event startedPlatelet count, ×109/L†Platelet response‡
6130 Gastrointestinal hemorrhage 4 8 No 
6130 Melena 4 8 No 
1131 Gingival bleeding 8 4 No 
0551 Epistaxis 17 6 Yes 
1230 Menorrhagia 46 14 Yes 
5730 Upper gastrointestinal hemorrhage 47 10 Yes 
1656 Conjunctival hemorrhage 49 89 Yes 
1633 Petechiae 71 5 Yes 
0130 Epistaxis 74 10 Yes 
5330 Hematoma (chest cavity) 86 3 Yes 
0130 Gastric ulcer hemorrhage 130 12 Yes 
0123 Vaginal hemorrhage 248 9 Yes 
0302 Purpura 395 4 Yes 
1623 Oral mucosal petechiae 531 5 Yes 
*

No fatal bleeding events were reported.

†

Platelet count at the time of the event, if available. If a platelet count at the time of the event was not available, the smaller of the 2 platelet counts taken immediately before or after the event was used.

‡

At any point during the study.

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