5)
Hypocalcaemia was reported in 35.7% of sorafenib treated patients compared to 11.0% of placebo patients. Most reports of hypocalcaemia were low grade. CTCAE grade 3 hypocalcaemia occurred in 6.8% of sorafenib treated patients and 1.9% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia occurred in 3.4% of sorafenib treated patients and 1.0% of patients in the placebo group.
Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2.
Table 2: Treatment-emergent laboratory test abnormalities reported in DTC patient (study 5) double blind period
|
Laboratory parameter,
(in % of samples investigated)
|
Sorafenib N=207
|
Placebo N=209
|
|
All Grades*
|
Grade 3*
|
Grade 4*
|
All Grades*
|
Grade 3*
|
Grade 4*
|
|
Blood and lymphatic system disorders
|
|
Anemia
|
30.9
|
0.5
|
0
|
23.4
|
0.5
|
0
|
|
Thrombocytopenia
|
18.4
|
0
|
0
|
9.6
|
0
|
0
|
|
Neutropenia
|
19.8
|
0.5
|
0.5
|
12
|
0
|
0
|
|
Lymphopenia
|
42
|
9.7
|
0.5
|
25.8
|
5.3
|
0
|
|
Metabolism and nutrition disorders
|
|
Hypokalemia
|
17.9
|
1.9
|
0
|
2.4
|
0
|
0
|
|
Hypophosphatemia**
|
19.3
|
12.6
|
0
|
2.4
|
1.4
|
0
|
|
Hepatobiliary disorders
|
|
Bilirubin increased
|
8.7
|
0
|
0
|
4.8
|
0
|
0
|
|
ALT increased
|
58.9
|
3.4
|
1.0
|
24.4
|
0
|
0
|
|
AST increased
|
|
