Table 2.
Safety outcomes (safety analysis set).
| AEs | Ivermectin N = 107 | Placebo N = 107 | ||
|---|---|---|---|---|
| All AEs, no. (%) | 29 (27.1) | 28 (26.2) | ||
| AEs by severity (CTCAE grade), no. (%) | ||||
| Grade 1 | 19 (17.8) | 17 (15.9) | ||
| Grade 2 | 9 (8.4) | 9 (8.4) | ||
| Grade 3 | 1 (0.9) | 1 (0.9) | ||
| Grade 4 | 0 | 1 (0.9) | ||
| Serious AEs, no. (%) | 1 (0.9) | 1 (0.9) | ||
| AEs that led to study discontinuation, no. (%) | 0 | 0 | ||
| All TEAEs, no. (%) | 6 (5.6) | 5 (4.7) | ||
| TEAEs by severity (CTCAE grade), no. (%) | ||||
| Grade 1 | 3 (2.8) | 3 (2.8) | ||
| Grade 2 | 2 (1.9) | 0 | ||
| Grade 3 | 1 (0.9) | 1 (0.9) | ||
| Grade 4 | 0 | 1 (0.9) | ||
| Serious TEAEs, no. (%) | 0 | 1 (0.9) | ||
| TEAEs that led to study discontinuation, no. (%) | 0 | 0 | ||
| TEAE by SOC and PT | Patients, No. (%) | Events, No. | Patients, No. (%) | Events, No. |
| Gastrointestinal disorders | 2 (1.9) | 2 | 1 (0.9) | 1 |
| Diarrhea | 2 (1.9) | 2 | 0 | 0 |
| Loose stools | 0 | 0 | 1 (0.9) | 1 |
| Hepatobiliary system disorders | 2 (1.9) | 2 | 2 (1.9) | 2 |
| Hepatic function abnormal | 1 (0.9) | 1 | 2 (1.9) | 2 |
| Liver disorders | 1 (0.9) | 1 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 0 | 0 | 1 (0.9) | 1 |
| Myalgia | 0 | 0 | 1 (0.9) | 1 |
| Skin and subcutaneous tissue disorders | 1 (0.9) | 1 | 1 (0.9) | 1 |
| Rash | 1 (0.9) | 1 | 1 (0.9) | 1 |
| Investigations | 1 (0.9) | 1 | 1 (0.9) | 2 |
| Aspartate aminotransferase increased | 0 | 0 | 1 (0.9) | 1 |
| Alanine aminotransferase increased | 0 | 0 | 1 (0.9) | 1 |
| Blood creatine phosphokinase increased | 1 (0.9) | 1 | 0 | 0 |
| TEAE grade ≥ 3 by PT | Patients, No. (%) | Events, No. | Patients, No. (%) | Events, No. |
| Hepatic function abnormal | 0 | 0 | 2 (1.9)a | 2 |
| Blood creatine phosphokinase increased | 1 (0.9) | 1 | 0 | 0 |
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event.
a
One grade 3 and one grade 4.