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Table 3 Summary of treatment-related adverse events (TRAE) in each cohort

From: Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients

  1 mg/kg (n = 15) 3 mg/kg (n = 15) 10 mg/kg (n = 6) Total (n = 36)
Case N (%) Case N (%) Case N (%) Case N (%)
Total TRAE 398 15 (100.00) 295 15 (100.00) 96 6 (100.00) 789 36 (100.00%)
TRAE ≥ grade 3 8 5 (33.33) 10 5 (33.33) 7 3 (50.00) 25 13 (36.11%)
Termination due to TRAE 0 0 (0.00) 0 0 (0.00) 0 0 (0.00) 0 0 (0.00%)
Pause due to TRAE 2 2 (13.33) 3 3 (20.00) 1 1 (16.67) 6 6 (16.67%)
Treatment-related SAE 3 2 (13.33) 1 1 (6.67) 3 2 (33.33) 7 5 (13.89%)
TRAE/SAE leading to death 0 0 (0.00) 0 0 (0.00) 2 2 (33.33) 2 2 (5.56%)
  1. By the safety data cutoff date of July 31, 2018, 19 months after the last patient in, the total number and incidence rate of TRAE in each cohort, grade 3 and above TRAE, termination and pause due to TRAE, SAE and TRAE/SAE leading to death were listed. Two TRAEs (10 mg/kg cohort) that leading to death were attributed to disease progression and possibly unrelated to JS001 according to investigator’s evaluation. “Related,” “probably related,” “possibly related,” and “possibly not related” are all classified as “study drug/treatment related” in this trial