Table 4.
Safety
|
Selonsertib 18 mg ± Simtuzumab (n = 32) |
Selonsertib 6 mg ± Simtuzumab (n = 30) |
Simtuzumab (n = 10) | |
|---|---|---|---|
| Patients with adverse events | 24 (75) | 26 (87) | 7 (70) |
| Patients with grade 3‐4 adverse events | 3 (9) | 1 (3) | 1 (10) |
| Patients with serious adverse events | 3 (9)a | 2 (7) † | 0 |
| Patients who discontinued study treatment due to adverse event | 2 (6) | 1 (3) | 0 |
| Most common adverse events | |||
| Headache | 9 (28) | 4 (13) | 0 |
| Nausea | 6 (19) | 4 (13) | 0 |
| Sinusitis | 4 (13) | 3 (10) | 1 (10) |
| Nasopharyngitis | 3 (9) | 4 (13) | 0 |
| Upper abdominal pain | 5 (16) | 1 (3) | 0 |
| Fatigue | 5 (16) | 1 (3) | 0 |
| Grade 3‐4 laboratory abnormalities ‡ | 9 (28) | 5 (17) | 4 (40) |
| Lymphocytes <500 mm3 | 1 (10) | 0 | 0 |
| Hypocalcemia <7.0 mg/dL | 0 | 0 | 1 (10) |
| Alkaline phosphatase >5 × ULN | 1 (3) | 0 | 0 |
| ALT >5 × ULN | 2 (6) | 0 | 0 |
| AST >5 × ULN | 2 (6) | 0 | 0 |
| Gamma‐glutamyl transferase >5 × ULN | 2 (6) | 1 (3) | 0 |
| Phosphate <1.5 mg/dL | 1 (3) | 0 | 0 |
| Serum glucose >250 mg/dL | 2 (6) | 4 (13) | 2 (20) |
| Glomerular filtration rate <30 mL/minute/1.73 m2 | 0 | 0 | 1 (10) |
| INR >2.5 × ULN | 1 (3) | 0 | 0 |
| Triglycerides >500 mg/dL | 2 (6) | 0 | 1 (10) |
a
A 59‐year‐old woman had a transient ischemic attack, a 54‐year‐old woman had hypoesthesia, and a 52‐year‐old woman had two serious adverse events: abdominal pain and influenza.
b
A 32‐year‐old woman experienced a serious adverse event of rectal bleeding, and a 57‐year‐old man experienced seven serious adverse events: chest pain, bronchitis, congestive cardiac failure, pneumonia, sepsis, and two events of dyspnea.
c
Values that were increased at least one toxicity grade from baseline at any time postbaseline, up to and including the last dosing date plus 30 days.
Abbreviations: INR, international normalized ratio; ULN, upper limit of normal.