Table 1.

Summary of clinical studies on the treatment of metastatic melanoma for which grade 3 or 4 AEs were reported

Comparator	Source study	Study setting	Phase	Sample size (n)	Treatment dose
Dabrafenib	Hauschild [46]	1st line	3	187	150 mg twice daily orally
Dacarbazine	Patel [47]	1st line	3	430	1000 mg/m2 on day 1 every 3 weeks
Fotemustine	Avril [48]	1st line	3	112	Weekly for 3 consecutive weeks at 100 mg/m2 followed by a 5-week rest period, with maintenance therapy for nonprogressive patients of 100 mg/m2 every 3 weeks
IL-2	Tarhini [49]	2nd line	2	26	600,000 IU/kg per dose for a maximum of 14 doses per cycle with a 1-week rest period between cycles. Stable or responding patients were offered an additional course after 6–8 weeks
Ipilimumab	Hersh [50]	1st line	2	37	3 mg/kg once every 4 weeks for four treatments
Ipilimumab	Hodi [8]	2nd line	3	137	3 mg/kg once every 3 weeks for four treatments
Temozolomide	Patel [47]	1st line	3	429	Orally once a day at a dose of 150 mg/m2/day for seven consecutive days every 2 weeks
Trametanib	Flaherty [51]	2nd line	3	214	2 mg twice daily orally
Vemurafenib	Chapman [52]	1st line	3	337	960 mg twice daily orally
Vemurafenib	Sosman [53]	2nd line	2	132	960 mg twice daily orally