Table 2.
TRAEs occurring in at least 2% of patients pooled from the double-blind phases of each study and patients with at least one gastrointestinal TRAE on treatment days 1 or 2 potentially related to opioid withdrawal
| Patients aged < 65 years | Patients aged ≥ 65 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo [n = 415] | All MNTX [n = 908] | Placebo [n = 133] | All MNTX [n = 171] | |||||
| Patients with one or more TRAEs | 83 (20.0) | 251 (27.6) | 33 (24.8) | 51 (29.8) | ||||
| TRAEs occurring in at least 2% of patients pooled from the double-blind phases of each study | ||||||||
| Abdominal pain | 21 (5.1) | 98 (10.8) | 7 (5.3) | 20 (11.7) | ||||
| Flatulence | 11 (2.7) | 37 (4.1) | 7 (5.3) | 10 (5.8) | ||||
| Nausea | 14 (3.4) | 55 (6.1) | 4 (3.0) | 10 (5.8) | ||||
| Diarrhea | 6 (1.4) | 45 (5.0) | 5 (3.8) | 7 (4.1) | ||||
| Dizziness | 2 (0.5) | 11 (1.2) | 1 (0.8) | 5 (2.9) | ||||
| Hyperhidrosis | 3 (0.7) | 27 (3.0) | 0 | 3 (1.8) | ||||
| Abdominal distension | 5 (1.2) | 18 (2.0) | 3 (2.3) | 1 (0.6) | ||||
| Abdominal pain upper | 9 (2.2) | 25 (2.8) | 0 | 1 (0.6) | ||||
| Placebo | All MNTX | Placebo | All MNTX | |||||
|---|---|---|---|---|---|---|---|---|
| Day 1 [n = 415] | Day 2 [n = 399] | Day 1 [n = 908] | Day 2 [n = 853] | Day 1 [n = 133] | Day 2 [n = 125] | Day 1 [n = 171] | Day 2 [n = 157] | |
| Patients with at least one gastrointestinal TRAE on treatment days 1 or 2 potentially related to opioid withdrawal | ||||||||
| Patients with one or more GI TRAEs | 11 (2.7) | 10 (2.5) | 83 (9.1) | 30 (3.5) | 5 (3.8) | 5 (4.0) | 13 (7.6) | 11 (7.0) |
| Abdominal discomfort | 0 | 1 (0.3) | 0 | 0 | 1 (0.8) | 0 | 0 | 1 (0.6) |
| Abdominal pain | 4 (1.0) | 5 (1.3) | 59 (6.5) | 23 (2.7) | 3 (2.3) | 3 (2.4) | 10 (5.8) | 6 (3.8) |
| Diarrhea | 1 (0.2) | 0 | 16 (1.8) | 3 (0.4) | 0 | 1 (0.8) | 1 (0.6) | 2 (1.3) |
| Gastrointestinal pain | 0 | 1 (0.3) | 1 (0.1) | 0 | 0 | 0 | 1 (0.6) | 0 |
| Nausea | 5 (1.2) | 5 (1.3) | 33 (3.6) | 9 (1.1) | 2 (1.5) | 2 (1.6) | 2 (1.2) | 3 (1.9) |
| Vomitinga | 1 (0.2) | 2 (0.5) | 13 (1.4) | 2 (0.2) | 0 | 1 (0.8) | 1 (0.6) | 1 (0.6) |
Data are expressed as n (%)
GI gastrointestinal, MNTX methylnaltrexone, TRAEs treatment-related adverse events
aIncludes vomiting and vomiting not otherwise specified