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Table 3 Safety Summary

From: Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma

Patient, n (%) 25 mg BID (n = 8) 50 mg BID Cont’ (n = 18) 50 mg BID Int’ (n = 9) 75 mg Total Daily (n = 7) 100 mg BIDa (n = 1) 300 mg BIDa (n = 7) Total (N = 50)
A. Treatment-Emergent Adverse Events
Any grade (≥10% of total patients)
 Fatigue 6 (75.0) 13 (72.2) 5 (55.6) 4 (57.1) 0 4 (57.1) 32 (64.0)
 Rashb 4 (50.0) 10 (55.6) 1 (11.1) 6 (85.7) 0 5 (71.4) 26 (52.0)
 Constipation 1 (12.5) 8 (44.4) 2 (22.2) 3 (42.9) 0 6 (85.7) 20 (40.0)
 Pruritusc 1 (12.5) 6 (33.3) 5 (55.6) 3 (42.9) 0 4 (57.1) 19 (38.0)
 Diarrhea 3 (37.5) 6 (33.3) 3 (33.3) 3 (42.9) 0 2 (28.6) 17 (34.0)
 Nausea 4 (50.0) 4 (22.2) 4 (44.4) 1 (14.3) 0 3 (42.9) 16 (32.0)
 ALT elevation 2 (25.0) 3 (16.7) 2 (22.2) 2 (28.6) 0 5 (71.4) 14 (28.0)
 Decreased appetite 0 5 (27.8) 4 (44.4) 2 (28.6) 0 2 (28.6) 13 (26.0)
 Headache 5 (62.5) 6 (33.3) 0 1 (14.3) 0 1 (14.3) 13 (26.0)
 AST elevation 2 (25.0) 3 (16.7) 1 (11.1) 1 (14.3) 0 5 (71.4) 12 (24.0)
 Vomiting 1 (12.5) 5 (27.8) 3 (33.3) 2 (28.6) 0 1 (14.3) 12 (24.0)
 Cough 4 (50.0) 3 (16.7) 2 (22.2) 0 0 2 (28.6) 11 (22.0)
 Arthralgia 3 (37.5) 1 (5.6) 3 (33.3) 1 (14.3) 0 2 (28.6) 10 (20.0)
 Pyrexia 2 (25.0) 3 (16.7) 2 (22.2) 1 (14.3) 0 1 (14.3) 9 (18.0)
 Abdominal pain 2 (25.0) 3 (16.7) 1 (11.1) 1 (14.3) 0 1 (14.3) 8 (16.0)
 Insomnia 1 (12.5) 4 (22.2) 0 2 (28.6) 0 1 (14.3) 8 (16.0)
 Chills 3 (37.5) 1 (5.6) 1 (11.1) 1 (14.3) 0 1 (14.3) 7 (14.0)
 Dizziness 1 (12.5) 3 (16.7) 1 (11.1) 1 (14.3) 0 1 (14.3) 7 (14.0)
 Anemia 1 (12.5) 1 (5.6) 1 (11.1) 1 (14.3) 0 2 (28.6) 6 (12.0)
 Myalgia 2 (25.0) 2 (11.1) 0 0 0 2 (28.6) 6 (12.0)
 Hypothyroidism 2 (25.0) 3 (16.7) 0 0 0 0 5 (10.0)
 Upper respiratory tract infection 0 2 (11.1) 0 3 (42.9) 0 0 5 (10.0)
Grade 3/4 (> 1 patient total)
 ALT elevation 0 2 (11.1) 0 1 (14.3) 0 5 (71.4) 8 (16.0)
 AST elevation 1 (12.5) 2 (11.1) 0 1 (14.3) 0 4 (57.1) 8 (16.0)
 Colitis 2 (25.0) 1 (5.6) 1 (11.1) 0 0 0 4 (8.0)
 Fatigue 0 2 (11.1) 1 (11.1) 0 0 0 3 (6.0)
 Anemia 0 0 1 (11.1) 0 0 1 (14.3) 2 (4.0)
 Confusional state 0 2 (11.1) 0 0 0 0 2 (4.0)
 Hyperglycemia 0 1 (5.6) 0 1 (14.3) 0 0 2 (4.0)
 Hypernatremia 0 1 (5.6) 0 1 (14.3) 0 0 2 (4.0)
 Hypotension 0 2 (11.1) 0 0 0 0 2 (4.0)
 Pruritusc 0 1 (5.6) 0 0 0 1 (14.3) 2 (4.0)
 Urinary tract infection 1 (12.5) 0 1 (11.1) 0 0 0 2 (4.0)
B. Immune-Related Adverse Events
Any grade (≥10% of total patients)
 Rashb 4 (50.0) 10 (55.6) 1 (11.1) 5 (71.4) 0 5 (71.4) 25 (50.0)
 ALT elevation 2 (25.0) 3 (16.7) 2 (22.2) 2 (28.6) 0 5 (71.4) 14 (28.0)
 Pruritusc 1 (12.5) 5 (27.8) 3 (33.3) 1 (14.3) 0 4 (57.1) 14 (28.0)
 AST elevation 2 (25.0) 3 (16.7) 1 (11.1) 1 (14.3) 0 5 (71.4) 12 (24.0)
 Hypothyroidism 2 (25.0) 3 (16.7) 0 0 0 0 5 (10.0)
Grade 3/4 (> 1 patient total)
 ALT elevation 0 2 (11.1) 0 1 (14.3) 0 5 (71.4) 8 (16.0)
 AST elevation 1 (12.5) 2 (11.1) 0 1 (14.3) 0 4 (57.1) 8 (16.0)
 Colitis 2 (25.0) 1 (5.6) 1 (11.1) 0 0 0 4 (8.0)
 Pruritusc 0 1 (5.6) 0 0 0 1 (14.3) 2 (4.0)
  1. ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, cont’ continuous, int’ intermittent, MedDRA Medical Dictionary for Regulatory Activities
  2. a Epacadostat 100-mg BID and 300-mg BID dose cohorts were not re-explored in this study after protocol amendment to evaluate lower doses of epacadostat
  3. b Rash included the following MedDRA preferred terms: rash, rash maculopapular, rash pruritic, rash generalized, and rash macular; patients were counted only once (a patient with multiple terms for rash was counted only once for the term “rash”)
  4. c Pruritus included the following MedDRA preferred terms: pruritus and pruritus generalized; patients were counted only once (a patient with multiple terms for pruritus was counted only once for the term “pruritus”)