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. 2015 Jan 27;112(4):650–659. doi: 10.1038/bjc.2014.653

Table 3. All grades AEs suspected to be study drug related occurring in at least 5% of all patients (safety cohort).

  Weekly schedule
Twice-weekly schedule
 
 
2.5 mg (N=3)
5 mg (N=5)
10 mg (N=7)
20 mg (N=6)
30 mg (N=5)
50 mg (N=22)
60 mg (N=5)
25 mg (N=11)
All pts (N=64)
  n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%)
Pts with ≥1 drug-related AEs
1 (33)
3 (60)
4 (57)
6 (100)
5 (100)
22 (100)
5 (100)
11 (100)
57 (89)
Constitutional
Asthenia 0 2 (40) 2 (29) 2 (33) 2 (40) 11 (50) 3 (60) 4 (36) 26 (41)
Insomnia
0
0
0
0
1 (20)
9 (41)
2 (40)
4 (36)
16 (25)
Gastrointestinal
Diarrhoea 0 3 (60) 2 (29) 6 (100) 4 (80) 18 (82) 5 (100) 9 (82) 47 (73)
Nausea 0 0 0 3 (50) 1 (20) 6 (27) 2 (40) 2 (18) 14 (22)
Anorexia 1 (33) 0 2 (29) 1 (17) 1 (20) 7 (32) 2 (40) 2 (18) 16 (25)
Abdominal pain 0 0 0 4 (67) 1 (20) 3 (14) 1 (20) 1 (9) 10 (16)
Vomiting 0 1 (20) 0 1 (17) 0 5 (23) 2 (40) 0 9 (14)
Weight loss
0
0
1 (14)
0
0
2 (9)
1 (20)
0
4 (6)
Neurology
Dizziness 0 2 (40) 0 1 (17) 0 6 (27) 1 (20) 2 (18) 12 (19)
Tremor 0 0 0 0 0 6 (27) 3 (60) 3 (27) 12 (19)
Ataxia 0 0 0 0 0 3 (14) 0 3 (27) 6 (10)
Cerebellar syndrome 0 0 0 0 0 1 (4) 2 (40) 2 (18) 5 (8)
Balance disorder 0 0 0 0 0 3 (14) 1 (20) 0 4 (6)
Headache 0 0 0 1 (17) 0 2 (9) 0 1 (9) 4 (6)
Muscle spasms
0
0
0
0
1 (20)
2 (9)
1 (20)
0
4 (6)
Laboratory
ALT increase 0 0 0 1 (17) 0 2 (9) 1 (20) 1 (9) 5 (8)
AST increase 0 0 0 1 (17) 0 2 (9) 1 (20) 1 (9) 5 (8)

Abbreviations: AE=adverse events; ALT=alanine transaminase; AST=aspartate aminotransferase; pts=patients.