Table 2.
Overall summary of treatment‐emergent AEsa occurring during the study period
| AEs, n (%) | Romiplostim (N = 60) |
|---|---|
| Total AEs | 59 (98·3) |
| Grade 3 | 31 (52·5) |
| Grade 4 | 5 (8·3) |
| Grade 5 | 3 (5·0) |
| AEs reported in ≥10% of patients | |
| Epistaxis | 20 (33·3) |
| Cough | 13 (21·7) |
| Arthralgia | 12 (20·0) |
| Haematoma | 12 (20·0) |
| Contusion | 11 (18·3) |
| Anaemia | 9 (15·0) |
| Abdominal pain | 9 (15·0) |
| Pyrexia | 8 (13·3) |
| Fatigue | 7 (11·7) |
| Headache | 7 (11·7) |
| Back pain | 7 (11·7) |
| Constipation | 6 (10·0) |
| Eye haemorrhage | 6 (10·0) |
| Bronchitis | 6 (10·0) |
| Nasopharyngitis | 6 (10·0) |
| Gingival bleeding | 6 (10·0) |
| Treatment‐related AEs | 14 (23·3) |
| Grade 3 | 2 (3·3) |
| Grade 4 | 1 (1·7) |
| Grade 5 | 1 (1·7) |
| Serious AEs | 22 (36·7) |
| Treatment‐related serious AEsb | 4 (6·7) |
| Fatal AEsc | 3 (5·0) |
| AEs leading to study withdrawal | 6 (10·0) |
AE, adverse event.
a
AEs were classified according to the Common Terminology Criteria for Adverse Events version 3.0 severity grading scale (http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf).
b
Treatment‐related serious AEs were cerebral ischaemia (grade 4)/intracranial haemorrhage (grade 2), chronic myeloid leukaemia (grade 3), pulmonary fibrosis (grade 5) and speech disorder (grade 3).
c
Fatal events were congestive heart failure, muscular dystrophy and pulmonary fibrosis.