Table 2.
Summary of Treatment-Emergent Adverse Events by eGFR at Baseline (Safety Population)
| COMPOSE-1/COMPOSE-2/COMPOSE-3 | ||
|---|---|---|
| Naldemedine 0.2 mg/day, % (n/N) | Placebo, % (n/N) | |
| Any TEAE | ||
| Overall | 47.1 (548/1163) | 45.6 (531/1165) |
| ≥90 mL/min/1.73 m2 (normal) | 44.6 (194/435) | 43.6 (202/463) |
| ≥60 to <90 mL/min/1.73 m2 (mild RI) | 49.0 (291/594) | 44.7 (256/573) |
| ≥30 to <60 mL/min/1.73 m2 (moderate RI) | 46.6 (62/133) | 55.9 (71/127) |
| TEAEs of GI Disorders SOC | ||
| Overall | 21.8 (253/1163) | 13.8 (161/1165) |
| ≥90 mL/min/1.73 m2 (normal) | 21.6 (94/435) | 12.5 (58/463) |
| ≥60 to <90 mL/min/1.73 m2 (mild RI) | 22.6 (134/594) | 14.7 (84/573) |
| ≥30 to <60 mL/min/1.73 m2 (moderate RI) | 18.0 (24/133) | 14.2 (18/127) |
| TEAEs of Opioid Withdrawal | ||
| Overall | ||
| ≥90 mL/min/1.73 m2 (normal) | 1.1 (5/435) | 0.4 (2/463) |
| ≥60 to <90 mL/min/1.73 m2 (mild RI) | 1.0 (6/594) | 0.9 (5/573) |
| ≥30 to <60 mL/min/1.73 m2 (moderate RI) | 0.8 (1/133) | 0 |
Abbreviations: eGFR, estimated glomerular filtration rate; GI, gastrointestinal; RI, renal impairment; SOC, System Organ Class; TEAE, treatment-emergent adverse event.