Treatment-related serious or severe, life-threatening, or fatal* adverse events
| Adverse event . | Patient ID . | Age . | Sex . | Study day started . | Continuing/resolved . | Severity† . | Led to discontinuation . | Serious‡ . |
|---|---|---|---|---|---|---|---|---|
| Thrombotic | ||||||||
| Myocardial infarction | 1658 | 85 | F | 60 | Resolved | 4 | No | Yes |
| Portal vein thrombosis | 1923 | 44 | F | 823 | Resolved | 3 | No | Yes |
| Deep vein thrombosis | 1923 | 44 | F | 908 | Resolved | 2 | Yes | Yes |
| Transverse sinus thrombosis | 2021 | 63 | M | 363 | Resolved | 3 | No | Yes |
| Thrombosis§ | 0230 | 57 | F | 95 | Resolved | 4 | No | Yes |
| ITP/Bleeding | ||||||||
| ITP‖ | 0230 | 57 | F | 70 | Resolved | 3 | No | Yes |
| Vaginal hemorrhage | 0123 | 27 | F | 248 | Continuing | 3 | Yes | Yes |
| Bone marrow reticulin¶ | 0331 | 60 | F | 317 | Continuing | 3 | Yes | Yes |
| Bone marrow reticulin | 3851 | 54 | F | 53 | Continuing | 3 | No | Yes |
| Bone marrow reticulin | 3630 | 58 | M | 50 | Resolved | 2 | No | Yes |
| Bone marrow reticulin | 1131 | 37 | M | 24 | Continuing | 2 | No | Yes |
| Bone marrow reticulin | 1202 | 31 | M | 154 | Continuing | 2 | Yes | Yes |
| Other events | ||||||||
| Anemia | 0123 | 27 | F | 279 | Continuing | 3 | No | Yes |
| Abdominal pain | 1923 | 44 | F | 823 | Resolved | 3 | No | Yes |
| Platelet count increased (> 1000 × 109/L) | 0321 | 34 | F | 615 | Resolved | 2 | No | Yes |
| Platelet count increased (1183 × 109/L) | 0322 | 53 | F | 611 | Resolved | 2 | No | Yes |
| Blindness | 2021 | 63 | M | 351 | Resolved | 3 | No | Yes |
| Papilloedema | 2021 | 63 | M | 358 | Resolved | 3 | No | Yes |
| Monoclonal gammopathy of undetermined significance | 0832 | 57 | M | 312 | Continuing | 4 | Yes | Yes |
| Fatigue | 0832 | 57 | M | 134 | Unknown | 3 | No | No |
| Diarrhea | 0832 | 57 | M | 138 | Resolved | 3 | No | No |
| Injection site irritation | 0322 | 53 | F | 722 | Resolved | 3 | No | No |
| Muscle spasms | 0105 | 48 | M | 365 | Resolved | 3 | No | No |
| Bone pain | 1922 | 51 | F | 75 | Resolved | 3 | No | No |
| Headache | 0121 | 50 | F | 232 | Resolved | 3 | No | No |
| Headache | 0121 | 50 | F | 307 | Resolved | 3 | No | No |
| Migraine | 1631 | 47 | F | 19 | Resolved | 3 | No | No |
| Migraine | 1631 | 47 | F | 172 | Resolved | 3 | No | No |
| Adverse event . | Patient ID . | Age . | Sex . | Study day started . | Continuing/resolved . | Severity† . | Led to discontinuation . | Serious‡ . |
|---|---|---|---|---|---|---|---|---|
| Thrombotic | ||||||||
| Myocardial infarction | 1658 | 85 | F | 60 | Resolved | 4 | No | Yes |
| Portal vein thrombosis | 1923 | 44 | F | 823 | Resolved | 3 | No | Yes |
| Deep vein thrombosis | 1923 | 44 | F | 908 | Resolved | 2 | Yes | Yes |
| Transverse sinus thrombosis | 2021 | 63 | M | 363 | Resolved | 3 | No | Yes |
| Thrombosis§ | 0230 | 57 | F | 95 | Resolved | 4 | No | Yes |
| ITP/Bleeding | ||||||||
| ITP‖ | 0230 | 57 | F | 70 | Resolved | 3 | No | Yes |
| Vaginal hemorrhage | 0123 | 27 | F | 248 | Continuing | 3 | Yes | Yes |
| Bone marrow reticulin¶ | 0331 | 60 | F | 317 | Continuing | 3 | Yes | Yes |
| Bone marrow reticulin | 3851 | 54 | F | 53 | Continuing | 3 | No | Yes |
| Bone marrow reticulin | 3630 | 58 | M | 50 | Resolved | 2 | No | Yes |
| Bone marrow reticulin | 1131 | 37 | M | 24 | Continuing | 2 | No | Yes |
| Bone marrow reticulin | 1202 | 31 | M | 154 | Continuing | 2 | Yes | Yes |
| Other events | ||||||||
| Anemia | 0123 | 27 | F | 279 | Continuing | 3 | No | Yes |
| Abdominal pain | 1923 | 44 | F | 823 | Resolved | 3 | No | Yes |
| Platelet count increased (> 1000 × 109/L) | 0321 | 34 | F | 615 | Resolved | 2 | No | Yes |
| Platelet count increased (1183 × 109/L) | 0322 | 53 | F | 611 | Resolved | 2 | No | Yes |
| Blindness | 2021 | 63 | M | 351 | Resolved | 3 | No | Yes |
| Papilloedema | 2021 | 63 | M | 358 | Resolved | 3 | No | Yes |
| Monoclonal gammopathy of undetermined significance | 0832 | 57 | M | 312 | Continuing | 4 | Yes | Yes |
| Fatigue | 0832 | 57 | M | 134 | Unknown | 3 | No | No |
| Diarrhea | 0832 | 57 | M | 138 | Resolved | 3 | No | No |
| Injection site irritation | 0322 | 53 | F | 722 | Resolved | 3 | No | No |
| Muscle spasms | 0105 | 48 | M | 365 | Resolved | 3 | No | No |
| Bone pain | 1922 | 51 | F | 75 | Resolved | 3 | No | No |
| Headache | 0121 | 50 | F | 232 | Resolved | 3 | No | No |
| Headache | 0121 | 50 | F | 307 | Resolved | 3 | No | No |
| Migraine | 1631 | 47 | F | 19 | Resolved | 3 | No | No |
| Migraine | 1631 | 47 | F | 172 | Resolved | 3 | No | No |
ITP indicates idiopathic thrombocytopenia purpura.
Three patients died during the study, but none of the deaths was considered related to treatment with romiplostim. None of the adverse events presented in this table was fatal.
Severity: 1, mild; 2, moderate; 3, severe; 4, life-threatening; 5, fatal.
Serious adverse event includes any event that is fatal, life-threatening (places subject at immediate risk of death), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard.
Thrombosed inflammatory fibrosis (preferred term thrombosis) was diagnosed at the site of a central line placed 13 years previously for blood draws because of poor vascular access.
Platelet count was 4 × 109/L on the day the event started.
Three additional patients had reports of bone marrow reticulin. In 1, reticulin was mild and not considered serious, and in the other 2, bone marrow reticulin was noted in the patient records but was not listed as an adverse event (see Table 3).