Table 3 All-cause adverse events
Part A | Part B | Total | ||||
|---|---|---|---|---|---|---|
Number of patients (%) | Saracatinib with C+P q3w ( N =24) | Saracatinib with C q3w ( N =21) | Saracatinib with P q3w ( N =27) | Saracatinib with P q1w ( N =24) | Saracatinib with C+P q3w ( N =20) | All patients ( N =116) |
AEs occurring in ⩾15% of patients overall | ||||||
Nausea | 10 (42) | 16 (76) | 10 (37) | 15 (63) | 16 (80) | 67 (58) |
Fatigue | 15 (63) | 11 (52) | 12 (44) | 13 (54) | 9 (45) | 60 (52) |
Decreased appetite | 12 (50) | 7 (33) | 10 (37) | 10 (42) | 8 (40) | 47 (41) |
Diarrhoea | 10 (42) | 6 (29) | 7 (26) | 11 (46) | 9 (45) | 43 (37) |
Vomiting | 8 (33) | 9 (43) | 7 (26) | 8 (33) | 9 (45) | 41 (35) |
Alopecia | 10 (42) | 2 (10) | 9 (33) | 6 (25) | 13 (65) | 40 (34) |
Anaemia | 10 (42) | 7 (33) | 4 (15) | 7 (29) | 11 (55) | 39 (34) |
Constipation | 8 (33) | 5 (24) | 8 (30) | 7 (29) | 8 (40) | 36 (31) |
Pyrexia | 8 (33) | 7 (33) | 5 (19) | 4 (17) | 9 (45) | 33 (28) |
Neutropenia | 9 (38) | 0 | 0 | 5 (21) | 12 (60) | 26 (22) |
Rash | 6 (25) | 2 (10) | 3 (11) | 9 (38) | 5 (25) | 25 (22) |
Dysgeusia | 6 (25) | 1 (5) | 4 (15) | 4 (17) | 6 (30) | 21 (18) |
Abdominal pain | 2 (8) | 5 (24) | 5 (19) | 5 (21) | 2 (10) | 19 (16) |
Arthralgia | 5 (21) | 0 | 5 (19) | 4 (17) | 5 (25) | 19 (16) |
Cough | 4 (17) | 0 | 3 (11) | 10 (42) | 1 (5) | 18 (16) |
Lethargy | 2 (8) | 2 (10) | 5 (19) | 5 (21) | 4 (20) | 18 (16) |
Weight decreased | 5 (21) | 3 (14) | 3 (11) | 3 (13) | 4 (20) | 18 (16) |
AEs of CTC grade ⩾3 occurring in ⩾5% of patients overall | ||||||
Neutropenia | 8 (33) | 0 | 0 | 4 (17) | 10 (50) | 22 (19) |
Fatigue | 4 (17) | 3 (14) | 3 (11) | 1 (4) | 5 (25) | 16 (14) |
Anaemia | 3 (13) | 2 (10) | 3 (11) | 2 (8) | 2 (10) | 12 (10) |
Hyponatraemia | 3 (13) | 5 (24) | 0 | 0 | 1 (5)a | 9 (8) |
Leucopenia | 2 (8) | 0 | 0 | 0 | 7 (35) | 9 (8) |
Asthenia | 1 (4) | 2 (10) | 3 (11) | 0 | 2 (10) | 8 (7) |
Dyspnoea | 1 (4) | 2 (10) | 1 (4) | 2 (8) | 0 | 6 (5) |
Hypokalaemia | 1 (4) | 2 (10) | 0 | 2 (8) | 1 (5) | 6 (5) |
Thrombocytopenia | 0 | 3 (14) | 0 | 0 | 3 (15) | 6 (5) |
