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Table 1 Characteristics of studies included to determine which AEs to include in the PRO-CTCAE for melanoma patients

From: Selection of patient reported outcomes questions reflecting symptoms for patients with metastatic melanoma receiving immunotherapy

Trial Design Enrollment size N= Study drug Dose (mg/kg)
Eggermont et al. [3] Adjuvant,
Randomized
phase 3
951 Ipilimumab 10
Hodi et al. [2] Phase 3
Randomized
676 Ipilimumab 3
Larkin et al. [4] Phase 3
randomized
945 Nivolumab
Nivolumab/Ipilimumab
Ipilimumab
3;
1 + 3;
3
Postow et al. [17] Double-blind
Phase 2 – dose ranging
142 Ipilimumab or
Ipilimumab/Nivolumab
3;
3 + 1
Ribas et al. [19] Phase 1b 655 Pembrolizumab
Pembrolizumab
10;
2
Ribas et al. [5] Phase 2 540 Pembrolizumab
Pembrolizumab
2;
10
Robert et al. [20] Randomized, phase 2 418 Nivolumab 3
Robert et al. [18] Phase 3 834 Pembrolizumab ipilimunab 10;
3
Weber et al. [21] Randomized, open-label phase 3 405 Nivolumab 3
Weber et al. [22] Randomized, open label, phase 2 140 Nivolumab
Ipilimumab
3;
3