Table 3. TEAEs a occurring on treatment day 1 and day 2.
| TEAE | Patients, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | SC Methylnaltrexone QD | SC Methylnaltrexone QOD b | Oral Methylnaltrexone | All Methylnaltrexone | ||||||
| Day 1
(n = 363) |
Day 2
(n = 354) |
Day 1
(n = 150) |
Day 2
(n = 145) |
Day 1
(n = 148) |
Day 2
(n = 138) |
Day 1
(n = 602) |
Day 2
(n = 571) |
Day 1
(n = 900) |
Day 2
(n = 854) |
|
| Patients with at least 1 TEAE | 24 (6.6) | 19 (5.4) | 33 (22.0) | 10 (6.9) | 31 (20.9) | 8 (5.8) | 82 (13.6) | 27 (4.7) | 146 (16.2) | 45 (5.3) |
| Abdominal pain | 3 (0.8) | 4 (1.1) | 17 (11.3) | 7 (4.8) | 11 (7.4) | 1 (0.7) | 24 (4.0) | 6 (1.1) | 52 (5.8) | 14 (1.6) |
| Nausea | 3 (0.8) | 3 (0.8) | 8 (5.3) | 4 (2.8) | 11 (7.4) | 0 | 11 (1.8) | 4 (0.7) | 30 (3.3) | 8 (0.9) |
| Hyperhidrosis | 1 (0.3) | 1 (0.3) | 8 (5.3) | 1 (0.7) | 7 (4.7) | 1 (0.7) | 5 (0.8) | 1 (0.2) | 20 (2.2) | 3 (0.4) |
| Diarrhea | 0 | 0 | 3 (2.0) | 1 (0.7) | 8 (5.4) | 2 (1.4) | 3 (0.5) | 1 (0.2) | 14 (1.6) | 4 (0.5) |
| Abdominal pain, upper | 3 (0.8) | 1 (0.3) | 1 (0.7) | 0 | 6 (4.1) | 1 (0.7) | 4 (0.7) | 1 (0.2) | 11 (1.2) | 2 (0.2) |
| Vomiting | 0 | 1 (0.3) | 0 | 0 | 7 (4.7) | 1 (0.7) | 3 (0.5) | 1 (0.2) | 10 (1.1) | 2 (0.2) |
| Hot flush | 3 (0.8) | 1 (0.3) | 3 (2.0) | 0 | 3 (2.0) | 2 (1.4) | 1 (0.2) | 0 | 7 (0.8) | 2 (0.2) |
QD = daily; QOD = every other day; SC = subcutaneous; TEAEs = treatment-emergent adverse events.
a
Reported by ≥2% of patients in any treatment group.
b
Treatment day 2 occurred on study day 3 for patients who received SC methlynaltrexone every other day.