Table 2. Treatment-related adverse events occurring in more than 20% of patients (N = 29)a.
| Adverse event | Grade 1 n (%) |
Grade 2 n (%) |
Grade 3b n (%) |
Grade 4 n (%) |
All grades n (%) |
|---|---|---|---|---|---|
| Neutropeniac | 0 | 1 (3) | 1 (3) | 24 (83) | 26 (90) |
| Fatigue | 6 (21) | 15 (52) | 2 (7) | 0 | 23 (79) |
| Nausea | 12 (41) | 7 (24) | 2 (7) | 0 | 21 (72) |
| Leukopeniad | 0 | 1 (3) | 13 (45) | 6 (21) | 20 (69) |
| Diarrhea | 5 (17) | 9 (31) | 3 (10) | 0 | 17 (59) |
| Alopecia | 9 (31) | 7 (24) | 0 | 0 | 16 (55) |
| Anemia | 7 (24) | 8 (28) | 1 (3) | 0 | 16 (55) |
| Vomiting | 9 (31) | 4 (14) | 1 (3) | 0 | 14 (48) |
| Mucosal inflammation | 8 (28) | 4 (14) | 1 (3) | 0 | 13 (45) |
| Rashe | 8 (28) | 5 (17.2) | 0 | 0 | 13 (45) |
| Hypophosphatemia | 3 (10) | 4 (14) | 4 (14) | 0 | 11 (38) |
| Febrile neutropenia | 0 | 0 | 2 (7) | 6 (21) | 8 (28) |
| Thrombocytopeniaf | 5 (17) | 4 (14) | 0 | 0 | 9 (31) |
| Pyrexia | 7 (24) | 0 | 0 | 0 | 7 (24) |
| Stomatitis | 3 (10) | 4 (14) | 0 | 0 | 7 (24) |
| Constipation | 5 (17) | 1 (3) | 0 | 0 | 6 (21) |
| Decreased appetite | 2 (7) | 4 (14) | 0 | 0 | 6 (21) |
| Headache | 5 (17) | 1 (3) | 0 | 0 | 6 (21) |
| Proteinuria | 2 (7) | 4 (14) | 0 | 0 | 6 (21) |
a‘Treatment-related’ indicates that the adverse event has been related to PF-03084014 and/or docetaxel.
bThree patients developed grade 3 pneumonia, and one patient each experienced aspartate aminotransferase elevation, dehydration, hyponatremia, colitis, hypokalemia, prolonged prothrombin time, and decreased performance status (all grade 3). One grade 5 treatment-related adverse event (septic shock) was reported in a patient who received PF-03084014 150 mg BID/docetaxel 75 mg/m2.
cIncludes neutropenia and decreased neutrophil count.
dIncludes leukopenia and decreased white blood cell count.
eIncludes rash, erythematous rash, maculopapular rash, acne, and dermatitis acneiform.
fIncludes thrombocytopenia and decreased platelet count.