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. Author manuscript; available in PMC: 2018 Jul 1.
Published in final edited form as: Lancet Oncol. 2017 Jun 4;18(7):863–873. doi: 10.1016/S1470-2045(17)30429-1

Table 3.

Any-cause adverse events (grade ≤2 events occurring in ≥10% of patients across cohorts)

Adverse event, n
(%)
Cohort A (n=76) Cohort B (n=16) Cohort C (n=16) Cohort D (n=17) Total (N=125)
Grade
1-2
Grade
3
Grade
4
Grade
5
Grade
1-2
Grade
3
Grade
4
Grade
5
Grade
1-2
Grade
3
Grade
4
Grade
5
Grade
1-2
Grade
3
Grade
4
Grade
5
Grade
1-2
Grade
3
Grade
4
Grade
5
Any 39 (51) 30 (39) 4 (5) 1 (1)* 7 (44) 8 (50) 1 (6) 0 7 (44) 8 (50) 1 (6) 0 9 (53) 7 (41) 1 (6) 0 62 (50) 53 (42) 7 (6) 1 (1)*
Pyrexia 42 (55) 2 (3) 0 0 7 (44) 0 0 0 7 (44) 1 (6) 0 0 7 (41) 1 (6) 0 0 63 (50) 4 (3) 0 0
Asthenia 27 (36) 0 0 0 5 (31) 0 0 0 2 (13) 1 (6) 0 0 5 (29) 0 0 0 39 (31) 1 (1) 0 0
Headache 26 (34) 1 (1) 0 0 4 (25) 1 (6) 0 0 6 (38) 0 0 0 7 (41) 1 (6) 0 0 43 (34) 3 (2) 0 0
Nausea 23 (30) 0 0 0 7 (44) 0 0 0 4 (25) 0 0 0 6 (35) 0 0 0 40 (32) 0 0 0
Diarrhoea 22 (29) 0 0 0 8 (50) 0 0 0 3 (19) 0 0 0 7 (41) 0 0 0 40 (32) 0 0 0
Vomiting 21 (28) 1 (1) 0 0 2 (13) 0 0 0 2 (13) 0 0 0 6 (35) 0 0 0 31 (25) 1 (1) 0 0
Chills 16 (21) 0 0 0 6 (38) 0 0 0 8 (50) 0 0 0 5 (29) 2 (12) 0 0 35 (28) 2 (2) 0 0
Arthralgia 15 (20) 0 0 0 3 (19) 0 0 0 2 (13) 0 0 0 6 (35) 0 0 0 26 (21) 0 0 0
Myalgia 13 (17) 0 0 0 5 (31) 0 0 0 1 (6) 1 (6) 0 0 5 (29) 1 (6) 0 0 24 (19) 2 (2) 0 0
Aspartate aminotransferase increase 11 (14) 0 0 0 3 (19) 0 0 0 2 (13) 0 0 0 3 (18) 0 0 0 19 (15) 0 0 0
Cough 10 (13) 0 0 0 2 (13) 0 0 0 1 (6) 0 0 0 3 (18) 0 0 0 16 (13) 0 0 0
Oedema peripheral 10 (13) 0 0 0 2 (13) 0 0 0 2 (13) 0 0 0 3 (18) 0 0 0 17 (14) 0 0 0
Back pain 9 (12) 0 0 0 1 (6) 0 0 0 3 (19) 0 0 0 2 (12) 0 0 0 15 (12) 0 0 0
Rash 9 (12) 0 0 0 6 (38) 1 (6) 0 0 3 (19) 0 0 0 3 (18) 0 0 0 21 (17) 1 (1) 0 0
Constipation 8 (11) 0 0 0 2 (13) 0 0 0 4 (25) 0 0 0 6 (35) 0 0 0 20 (16) 0 0 0
Decreased appetite 8 (11) 0 0 0 4 (25) 0 0 0 7 (44) 1 (6) 0 0 3 (18) 0 0 0 22 (18) 1 (1) 0 0
Pain in extremity 8 (11) 0 0 0 3 (19) 0 0 0 3 (19) 0 0 0 2 (12) 0 0 0 16 (13) 0 0 0
Dizziness 5 (7) 0 0 0 5 (31) 0 0 0 0 0 0 0 3 (18) 0 0 0 13 (10) 0 0 0
Fatigue 7 (9) 0 0 0 4 (25) 0 0 0 7 (44) 1 (6) 0 0 3 (18) 0 0 0 21 (17) 1 (1) 0 0
Abdominal pain 6 (8) 0 0 0 2 (13) 0 0 0 0 0 0 0 5 (29) 0 0 0 13 (10) 0 0 0
Alanine aminotransferase increased 7 (9) 0 0 0 2 (13) 0 0 0 1 (6) 0 0 0 2 (12) 1 (6) 0 0 13 (10) 0 0 0
Dry skin 6 (8) 0 0 0 2 (13) 0 0 0 3 (19) 0 0 0 3 (18) 0 0 0 14 (11) 0 0 0
*

Intracranial tumour haemorrhage, considered to be unrelated to study treatment.