Table 4 |
||||
|
Number (%) of patients with non-hematological adverse events by severity and relationship to study drug. |
||||
|
N = 95 |
Grade 1/2 |
Grade 3/4 |
||
|
|
||||
|
Preferred term |
total |
related |
Total |
related |
|
|
||||
|
nausea |
34(35.8) |
26(27.4) |
2(2.1) |
1(1.1) |
|
|
||||
|
oedema |
8(8.4) |
8(8.4) |
2(2.1) |
1(1.1) |
|
oedema peripheral |
29(30.5) |
23(24.1) |
-- |
-- |
|
oedema genital |
1(1.1) |
1(1.1) |
-- |
|
|
Eyelid oedema |
23(24.2) |
23(24.2) |
-- |
-- |
|
Face oedema |
6(6.3) |
6(6.3) |
-- |
-- |
|
Periorbital edema |
8(8.4) |
8(8.4) |
-- |
-- |
|
|
||||
|
Vomiting |
12(12.6) |
8(8.4) |
5(5.3) |
1(1.1) |
|
|
||||
|
Muscle cramp |
17(17.9) |
15(15.8) |
-- |
-- |
|
Muscle spasticity |
2(2.1) |
1(1.1) |
-- |
-- |
|
|
||||
|
Diarrhea |
25(26.3) |
19(20.0) |
1(1.1) |
1(1.1) |
|
|
||||
|
Dermatitis allergic |
1(1.1) |
1(1.1) |
-- |
-- |
|
Rash |
2(2.1) |
1(1.1) |
-- |
-- |
|
|
||||
|
Headache |
8(8.4) |
2(2.1) |
1(1.1) |
1(1.1) |
|
|
||||
|
Abdominal pain |
24(25.3) |
4(4.2) |
3(3.2) |
-- |
|
|
||||
|
Arthralgia |
9(9.5) |
2(2.1) |
1(1.1) |
-- |
|
|
||||
|
Schlemmer et al. European Journal of Medical Research 2011 16:206 doi:10.1186/2047-783X-16-5-206 |
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