Research Article
Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
Table 3
Gastrointestinal AEs (≥2% in any treatment group) during weeks 1 through 12 and weeks 13 through 24.
| | AE, n (%) | PEG 3350 (N = 204) | Placebo (N = 100) | All subjects (N = 304) | 95% CI† | P value‡ |
| | Weeks 1–12 | | Any GI AE | 70 (34) | 17 (17) | 87 (29) | 0.0748, 0.2714 | 0.0018 | | Diarrhea | 28 (14) | 6 (6) | 34 (11) | 0.0109, 0.1436 | 0.0525 | | Loose stools | 16 (8) | 1 (1) | 17 (6) | 0.0267, 0.1102 | 0.0148 | | Flatulence | 13 (6) | 2 (2) | 15 (5) | 0.0004, 0.087 | 0.1564 | | Abdominal distension | 10 (5) | 1 (1) | 11 (4) | 0.0035, 0.0745 | 0.1090 | | Nausea | 9 (4) | 1 (1) | 10 (3) | –15 E-5, 0.0684 | 0.1742 | | Abdominal pain | 2 (1) | 2 (2) | 4 (1) | –0.041, 0.0204 | 0.6004 | | Dyspepsia | 1 (0) | 2 (2) | 3 (1) | –0.044, 0.014 | 0.2527 |
| | Weeks 13–24 | | Any GI AE | 19 (9) | 12 (12) | 31 (10) | –0.102, 0.0483 | 0.5455 | | Diarrhea | 12 (6) | 7 (7) | 19 (6) | –0.071, 0.0483 | 0.8016 | | Loose stools | 0 | 2 (2) | 2 (1) | –0.047, 0.0074 | 0.1075 |
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Abbreviations: AE, adverse event; CI, confidence interval; GI, gastrointestinal; PEG, polyethylene glycol. †95% CI for difference in proportion. ‡Two-tailed Fisher’s exact test.
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