Extended Data Table 3.
Safety of cobimetinib in phase 2 study in histiocytosis patients
| Grade 1/2(%) | Grade 3/4 (%) | All (%) | |
|---|---|---|---|
| Rash* | 15 (83) | 0 (0) | 15 (83) |
| Diarrhea | 11 (61) | 2 (11) | 13 (72) |
| Creatine phosphokinase elevation | 10 (56) | 1 (6) | 11 (61) |
| Hypomagnesemia | 10 (56) | 0 (0) | 10 (56) |
| Alkaline phosphatase increased | 9 (50) | 0 (0) | 9 (50) |
| AST/ALT elevation | 8 (44) | 0 (0) | 8 (44) |
| Nausea | 7 (39) | 0 (0) | 7 (39) |
| Anemia | 4 (22) | 2 (11) | 6 (33) |
| Dry skin | 5 (28) | 0 (0) | 5 (28) |
| Infection# | 5 (28) | 0 (0) | 5 (28) |
| Vomiting | 5 (28) | 0 (0) | 5 (28) |
| Abdominal disturbance | 4 (22) | 0 (0) | 4 (22) |
| Edema limbs | 4 (22) | 0 (0) | 4 (22) |
| Fatigue | 4 (22) | 0 (0) | 4 (22) |
| Hyponatremia | 2 (11) | 2 (11) | 4 (22) |
| Anorexia | 3 (17) | 0 (0) | 3 (17) |
| Hypoalbuminemia | 3(17) | 0(0) | 3(17) |
| Hypocalcemia | 3 (17) | 0 (0) | 3 (17) |
| Pruritus | 3 (17) | 0 (0) | 3 (17) |
| Serum amylase increased | 2 (11) | 1 (6) | 3 (17) |
| White blood cell decreased | 3 (17) | 0 (0) | 3 (17) |
| Hypokalemia | 0 (0) | 2 (11) | 2 (11) |
| Lipase increased | 1 (6) | 1 (6) | 2 (11) |
| Lymphocyte count decreased | 0 (0) | 1 (6) | 1 (6) |
| Retinal vein occlusion | 0 (0) | 1 (6) | 1 (6) |
◊
Adverse events listed here are those that were attributed by investigators as related to cobimetinib and occurred in at least 15% of patients, regardless of grade, or of any frequency, for grade ≥3.
*
Combines the following terms: Rash acneiform, rash maculo-papular.
#
Combines the following terms: bladder infection, bronchial infection, oral infection, tooth infection, upper respiratory infection, urinary tract infection, infections - other.