Table 4. TEAEs a occurring after treatment day 2.
| TEAE | Patients, n (%) | |||
|---|---|---|---|---|
| Placebo
(n = 363) |
SC Methylnaltrexone
(n = 298) |
Oral Methylnaltrexone
(n = 602) |
All Methylnaltrexone
(n = 900) |
|
| Patients with at least 1 TEAE | 203 (55.9) | 152 (51.0) | 309 (51.3) | 461 (51.2) |
| Abdominal pain | 28 (7.7) | 28 (9.4) | 21 (3.5) | 49 (5.4) |
| Nausea | 28 (7.7) | 16 (5.4) | 25 (4.2) | 41 (4.6) |
| Diarrhea | 19 (5.2) | 18 (6.0) | 32 (5.3) | 50 (5.6) |
| Vomiting | 18 (5.0) | 5 (1.7) | 12 (2.0) | 17 (1.9) |
| Urinary tract infection | 15 (4.1) | 12 (4.0) | 21 (3.5) | 33 (3.7) |
| Upper respiratory tract infection | 13 (3.6) | 3 (1.0) | 24 (4.0) | 27 (3.0) |
| Flatulence | 13 (3.6) | 7 (2.3) | 17 (2.8) | 24 (2.7) |
| Back pain | 12 (3.3) | 8 (2.7) | 21 (3.5) | 29 (3.2) |
| Headache | 12 (3.3) | 12 (4.0) | 15 (2.5) | 27 (3.0) |
| Abdominal pain, upper | 9 (2.5) | 5 (1.7) | 12 (2.0) | 17 (1.9) |
| Influenza | 8 (2.2) | 3 (1.0) | 12 (2.0) | 15 (1.7) |
| Anxiety | 7 (1.9) | 1 (0.3) | 16 (2.7) | 17 (1.9) |
| Dizziness | 3 (0.8) | 7 (2.3) | 5 (0.8) | 12 (1.3) |
SC = subcutaneous; TEAEs = treatment-emergent adverse events.
a
Reported by ≥2% of patients in any treatment group.