Table 2.
Safety (ITT population) according to the number of patients with at least one reported adverse reaction; cutoff date: 31 January 2012.
| Number of patients (%) | Masitinib (n = 23) | Sunitinib (n = 21) | P-valuea |
|---|---|---|---|
| Summary of AE | |||
| All AE | 22 (96%) | 21 (100%) | 1.000 |
| Severe AE | 12 (52%) | 19 (91%) | 0.008 |
| Nonfatal serious AE | 3 (13%) | 7 (33%) | 0.155 |
| Death under study treatment (plus 28 days) | 0 (0%) | 3 (14%) | 0.100 |
| Nonhaematological G3/4 | 11 (48%) | 16 (76%) | 0.069 |
| Any G4 AE | 1 (4%) | 2 (10%) | 1.000 |
| AE leading to: | |||
| Permanent discontinuation | 1 (4%) | 5 (24%) | 0.088 |
| Temporary interruption | 9 (39%) | 9 (43%) | 1.000 |
| Dose reduction | 5 (22%) | 8 (38%) | 0.325 |
| AEs of interestb | |||
| Nausea/vomiting | 16 (70%) | 7 (33%) | 0.033 |
| Diarrhea | 12 (52%) | 12 (57%) | 0.771 |
| Edema | 11 (48%) | 9 (43%)c | 0.771 |
| Rash/pruritus | 13 (57%)c | 12 (57%) | 1.000 |
| Neutropenia | 2 (9%) | 6 (29%) | 0.126 |
| Abdominal pain | 1 (4%) | 7 (33%) | 0.019 |
| Thrombocytopenia | 0 (0%) | 7 (33%) | 0.003 |
| Hypertension | 1 (4%) | 7 (33%) | 0.019 |
| Mucosal inflammation | 1 (4%) | 6 (29%) | 0.042 |
| Dysgeusia | 1 (4%) | 6 (29%) | 0.042 |
| Palmar-plantar ES | 1 (4%) | 6 (29%) | 0.042 |
| Other common AEs (≥15%) | |||
| Asthenia | 10 (44%) | 14 (67%) | 0.143 |
| Edema peripheral | 6 (26%) | 7 (33%) | 0.744 |
| Anemia | 12 (52%) | 6 (29%) | 0.136 |
| Neutropenia | 2 (9%) | 6 (29%) | 0.126 |
| Lymphopenia | 3 (13%) | 5 (24%) | 0.448 |
| Leukopenia | 2 (9%) | 5 (24%) | 0.232 |
| Headache | 1 (4%) | 5 (24%) | 0.088 |
| Anorexia | 5 (22%) | 5 (24%) | 1.000 |
| Gastroesophageal reflux | 4 (17%) | 4 (19%) | 1.000 |
| BPD | 7 (30%) | 2 (10%) | 0.137 |
| Eyelid edema | 6 (26%) | 2 (10%) | 0.245 |
aFisher's exact test.
bAdverse events commonly associated with tyrosine kinase inhibitors or reported with a significantly higher frequency in one treatment arm.
cIncluding one G3 AE (edema or pruritus as applicable).
AE, adverse event; G3, grade 3 AE; G4, grade 4 AE; Palmar-plantar ES, Palmar-plantar erythrodysesthesia syndrome; BPD, Blood phosphorus decreased.