Non-Hematologic Malignancies During Double-Blind
Phase*
Studies 1027 and 1028
Studies 1027 and 1028
Numbers of Subjects with an AE
0
1
0
Bowen’s disease
0
1
1
Basal cell carcinoma
0
1
0
Skin cancer
0
0
1
Liver metastases
0
0
1
Oesophageal carcinoma
7
9
10
TOTAL
1
1
3
Squamous cell carcinoma
3
2
1
Kaposi’s sarcoma
3
3
3
Anal cancer
Placebo
(n=209)
MVC BID
(n=426)
MVC QD
(n=414)
Malignancy
* A subject could have more than one type of
adverse event.