Summary of safety findings
. | Total population (N = 60) . | Eltrombopag switched (n = 38) . | Romiplostim switched (n = 22) . |
---|---|---|---|
TEAE | 35 (58.3) | 20 (52.6) | 15 (68.2) |
Serious TEAE | 6 (10.0) | 4 (10.5) | 2 (9.1) |
Thrombocytopenia | 2 (3.3) | 2 (5.3) | 0 |
Rectal hemorrhage | 1 (1.7) | 0 | 1 (4.5) |
Sudden death | 1 (1.7) | 0 | 1 (4.5) |
Osteoarthritis | 1 (1.7) | 1 (2.6) | 0 |
Nephrolithiasis | 1 (1.7) | 1 (2.6) | 0 |
AESI | 1 (1.7) | 0 | 1 (4.5) |
Thrombotic events | 0 | 0 | 0 |
Bleeding events | 1 (1.7) | 0 | 1 (4.5) |
TEAE related to avatrombopag | 15 (25.0) | 9 (23.7) | 6 (27.3) |
Thrombocytopenia | 2 (3.3) | 1 (2.6) | 1 (4.5) |
Dyspepsia | 1 (1.7) | 0 | 1 (4.5) |
Nausea | 1 (1.7) | 1 (2.6) | 0 |
Vomiting | 1 (1.7) | 1 (2.6) | 0 |
Fatigue | 2 (3.3) | 0 | 2 (9.1) |
Influenza-like illness | 1 (1.7) | 0 | 1 (4.5) |
Edema peripheral | 1 (1.7) | 1 (2.6) | 0 |
Contusion | 2 (3.3) | 2 (5.3) | 0 |
PC decreased | 1 (1.7) | 1 (2.6) | 0 |
PC increased | 1 (1.7) | 1 (2.6) | 0 |
Dizziness | 1 (1.7) | 0 | 1 (4.5) |
Headache | 4 (6.7) | 3 (7.9) | 1 (4.5) |
Hypoesthesia | 1 (1.7) | 0 | 1 (4.5) |
Paresthesia | 1 (1.7) | 0 | 1 (4.5) |
Insomnia | 1 (1.7) | 1 (2.6) | 0 |
Heavy menstrual bleeding | 1 (1.7) | 1 (2.6) | 0 |
Severe TEAE | 8 (13.3) | 4 (10.5) | 4 (18.2) |
Thrombocytopenia | 3 (5.0) | 2 (5.3) | 1 (4.5) |
Rectal hemorrhage | 1 (1.7) | 0 | 1 (4.5) |
Sudden death | 1 (1.7) | 0 | 1 (4.5) |
Osteoarthritis | 1 (1.7) | 1 (2.6) | 0 |
Headache | 1 (1.7) | 0 | 1 (4.5) |
Nephrolithiasis | 1 (1.7) | 1 (2.6) | 0 |
TEAE leading to avatrombopag discontinuation | 2 (3.3) | 1 (2.6) | 1 (4.5) |
Thrombocytopenia | 1 (1.7) | 1 (2.6) | 0 |
Headache | 1 (1.7) | 0 | 1 (4.5) |
. | Total population (N = 60) . | Eltrombopag switched (n = 38) . | Romiplostim switched (n = 22) . |
---|---|---|---|
TEAE | 35 (58.3) | 20 (52.6) | 15 (68.2) |
Serious TEAE | 6 (10.0) | 4 (10.5) | 2 (9.1) |
Thrombocytopenia | 2 (3.3) | 2 (5.3) | 0 |
Rectal hemorrhage | 1 (1.7) | 0 | 1 (4.5) |
Sudden death | 1 (1.7) | 0 | 1 (4.5) |
Osteoarthritis | 1 (1.7) | 1 (2.6) | 0 |
Nephrolithiasis | 1 (1.7) | 1 (2.6) | 0 |
AESI | 1 (1.7) | 0 | 1 (4.5) |
Thrombotic events | 0 | 0 | 0 |
Bleeding events | 1 (1.7) | 0 | 1 (4.5) |
TEAE related to avatrombopag | 15 (25.0) | 9 (23.7) | 6 (27.3) |
Thrombocytopenia | 2 (3.3) | 1 (2.6) | 1 (4.5) |
Dyspepsia | 1 (1.7) | 0 | 1 (4.5) |
Nausea | 1 (1.7) | 1 (2.6) | 0 |
Vomiting | 1 (1.7) | 1 (2.6) | 0 |
Fatigue | 2 (3.3) | 0 | 2 (9.1) |
Influenza-like illness | 1 (1.7) | 0 | 1 (4.5) |
Edema peripheral | 1 (1.7) | 1 (2.6) | 0 |
Contusion | 2 (3.3) | 2 (5.3) | 0 |
PC decreased | 1 (1.7) | 1 (2.6) | 0 |
PC increased | 1 (1.7) | 1 (2.6) | 0 |
Dizziness | 1 (1.7) | 0 | 1 (4.5) |
Headache | 4 (6.7) | 3 (7.9) | 1 (4.5) |
Hypoesthesia | 1 (1.7) | 0 | 1 (4.5) |
Paresthesia | 1 (1.7) | 0 | 1 (4.5) |
Insomnia | 1 (1.7) | 1 (2.6) | 0 |
Heavy menstrual bleeding | 1 (1.7) | 1 (2.6) | 0 |
Severe TEAE | 8 (13.3) | 4 (10.5) | 4 (18.2) |
Thrombocytopenia | 3 (5.0) | 2 (5.3) | 1 (4.5) |
Rectal hemorrhage | 1 (1.7) | 0 | 1 (4.5) |
Sudden death | 1 (1.7) | 0 | 1 (4.5) |
Osteoarthritis | 1 (1.7) | 1 (2.6) | 0 |
Headache | 1 (1.7) | 0 | 1 (4.5) |
Nephrolithiasis | 1 (1.7) | 1 (2.6) | 0 |
TEAE leading to avatrombopag discontinuation | 2 (3.3) | 1 (2.6) | 1 (4.5) |
Thrombocytopenia | 1 (1.7) | 1 (2.6) | 0 |
Headache | 1 (1.7) | 0 | 1 (4.5) |
Data are presented as n (%).