Table 2.

Severity of drug-related AEs reported in more than 10% of the study patients

All AEs,Related AEs, n (%)
n (%)Grade 1/2Grade 3/4
Skin-related toxic effects
 Rash, folliculitis, dry skin90 (95)79 (83)25 (26)
Gastrointestinal disorders
 Diarrhea, nausea, vomiting84 (88)77 (81)13 (14)
General disorders
 Edema, asthenia, fatigue, mucosal inflammation80 (84)59 (62)12 (13)
Eye disorders
 SRD, blurred vision67 (71)58 (61)9 (10)
Laboratory abnormalities
 CPK increased45 (47)25 (26)25 (26)
Respiratory, thoracic, and mediastinal disorders
 Cough, dyspnea, pleural effusion, pulmonary embolism45 (47)13 (14)5 (5)
Infections
 Oral candidiasis, subcutaneous abscess, cellulitis37 (40)13 (14)3 (3)
Nervous system disorders
 Headache, dysgeusia32 (34)16 (17)2 (2)
Metabolism and nutrition disorders
 Decreased appetite, hypocalcaemia26 (27)14 (15)2 (2)