Table 3.
Anorectal symptoms and AEs related to product use in the past 2 weeks among AMP Study participants
| No producta (N = 117) | Product
|
Test of fixed effectb F value (p) |
|||
|---|---|---|---|---|---|
| Enema (N = 103) | Applicator (N = 103) | Suppository (N = 104) | |||
| n (%) | n (%) | n (%) | n (%) | ||
| Anorectal symptoms—past 2 weeks | |||||
| Reported ≥1 anorectal symptom | 20 (17.5) | 15 (14.9) | 13 (12.6) | 23 (22.1) | 1.3 (0.3) |
| # Anorectal symptoms reported | 34 | 27 | 20 | 39 | |
| Swelling | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Itching | 5 (14.7) | 5 (18.5) | 3 (15.0) | 7 (17.9) | |
| Pain | 2 (5.9) | 0 (0.0) | 2 (10.0) | 1 (2.6) | |
| Needing to have a bowel movement | 5 (14.7) | 5 (18.5) | 2 (10.0) | 2 (5.1) | |
| Constipation | 5 (14.7) | 1 (3.7) | 2 (10.0) | 2 (5.1) | |
| Diarrhea | 6 (17.6) | 4 (14.8) | 5 (25.0) | 8 (20.5) | |
| Bloody bowel movement | 1 (2.9) | 3 (11.1) | 1 (5.0) | 2 (5.1) | |
| Increased stool frequency | 1 (2.9) | 1 (3.7) | 0 (0.0) | 0 (0.0) | |
| Increased farting | 3 (8.8) | 3 (11.1) | 2 (10.0) | 5 (12.8) | |
| Wetness/discharge | 0 (0.0) | 0 (0.0) | 1 (5.0) | 4 (10.3) | |
| Burning inside butt | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.1) | |
| Burning outside or on edge of butt | 1 (2.9) | 0 (0.0) | 0 (0.0) | 1 (2.6) | |
| Irritation | 2 (5.9) | 4 (14.8) | 0 (0.0) | 5 (12.8) | |
| Hemorrhoids | 1 (2.9) | 1 (3.7) | 1 (5.0) | 0 (0.0) | |
| Bumps/lumps inside butt | 1 (2.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Bumps/lumps outside butt | 1 (2.9) | 0 (0.0) | 1 (5.0) | 0 (0.0) | |
| Severity of symptoms | |||||
| Mild | 26 (76.5) | 19 (70.4) | 11 (55.5) | 22 (56.4) | |
| Moderate | 7 (20.6) | 6 (22.2) | 6 (30.0) | 16 (41.0) | |
| Strong | 1 (2.9) | 2 (7.4) | 3 (15.0) | 1 (2.6) | |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Adverse events (AEs)—past 2 weeks | |||||
| Reported ≥ 1 AE related to product use | – | 12 (11.7) | 9 (8.7) | 17 (16.4) | 1.4 (0.3) |
| # AEs related to product use reported | – | 22 | 15 | 32 | |
| Bloating/fullness | 5 (22.7) | 2 (13.3) | 5 (15.6) | ||
| Bloody bowel movement | 1 (4.6) | 1 (6.7) | 1 (3.1) | ||
| Constipation | 0 (0.0) | 1 (6.7) | 1 (3.1) | ||
| Diarrhea | 4 (18.2) | 3 (20.0) | 6 (18.8) | ||
| Irritation | 3 (13.6) | 0 (0.0) | 4 (12.5) | ||
| Itching | 2 (9.1) | 1 (6.7) | 5 (15.6) | ||
| Burning | 1 (4.6) | 0 (0.0) | 2 (6.3) | ||
| Soiling | 1 (4.6) | 0 (0.0) | 0 (0.0) | ||
| Abdominal pain | 1 (4.6) | 0 (0.0) | 0 (0.0) | ||
| Urgency | 2 (9.1) | 1 (6.7) | 2 (6.3) | ||
| Wetness/discharge | 1 (4.6) | 2 (13.3) | 4 (12.5) | ||
| Flatulence | 0 (0.0) | 1 (6.7) | 0 (0.0) | ||
| Incontinence | 0 (0.0) | 1 (6.7) | 0 (0.0) | ||
| Pain | 1 (4.6) | 1 (6.7) | 1 (3.1) | ||
| Discolored stool | 0 (0.0) | 0 (0.0) | 1 (3.1) | ||
| Headache | 0 (0.0) | 1 (6.7) | 0 (0.0) | ||
| Severity of AEs related to product use | |||||
| Grade 1—mild | – | 21 (95.5) | 14 (93.3) | 32 (100.0) | |
| Grade 2—moderate | – | 1 (4.6) | 1 (6.7) | 0 (0.0) | |
| Grade 3—severe | – | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Grade 4—potentially life threatening | – | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
p = p value
a
Initial 2 week screening period between Visits 1 and 2 during which participants were not asked to use any products
b
Test of equality across products based on results from logistic random effects models