Table 4.
Summary of Adverse Events During the RCT and the OLE Study
| RCT | OLE study | ||
|---|---|---|---|
| Adverse event, n (%) | MNTX 8 mg or 12 mg QOD (n=116) | Placebo (n=114) | MNTX 8 mg or 12 mg PRN (n=149) |
| SAE | 14 (12.1) | 24 (21.1) | 59 (39.6) |
| Any AE | 95 (81.9) | 84 (73.7) | 135 (90.6) |
| Drug-related AEs | 49 (42.2) | 21 (18.4) | 38 (25.5) |
| Most common AEsa | |||
| Abdominal pain | 39 (33.6) | 19 (16.7) | 40 (26.8) |
| Nausea | 13 (11.2) | 18 (15.8) | 21 (14.1) |
| Back pain | 9 (7.8) | 3 (2.6) | 7 (4.7) |
| Diarrhea | 9 (7.8) | 15 (13.2) | 24 (16.1) |
| Fall | 9 (7.8) | 4 (3.5) | 21 (14.1) |
| Flatulence | 8 (6.9) | 5 (4.4) | 7 (4.7) |
| Confusional state | 7 (6.0) | 9 (7.9) | 23 (15.4) |
| Peripheral edema | 7 (6.0) | 4 (3.5) | 26 (17.4) |
| Vomiting | 5 (4.3) | 10 (8.8) | 10 (6.7) |
a
Reported in >5% of patients in any group in the RCT and listed by most common AE during the RCT for the MNTX group.
AE, adverse event; MNTX, methylnaltrexone; OLE, open-label extension; PRN, as needed; QOD, every other day; RCT, randomized, placebo-controlled trial; SAE, serious adverse event.