Table 2.
TEAEs occurring during the course of the study
| TEAE, n (%) | Drug‐related TEAE, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MIRA + SOLI (n = 166) | MIRA + PRO (n = 161) | MIRA + IMI (n = 161) | MIRA + TOL (n = 159) | Total (n = 647) | MIRA + SOLI (n = 166) | MIRA + PRO (n = 161) | MIRA + IMI (n = 161) | MIRA + TOL (n = 159) | Total (n = 647) | |
| TEAE | 131 (78.9) | 135 (83.9) | 133 (82.6) | 120 (75.5) | 519 (80.2) | 76 (45.8) | 81 (50.3) | 72 (44.7) | 74 (46.5) | 303 (46.8) |
| Serious TEAE | 10 (6.0) | 4 (2.5) | 5 (3.1) | 9 (5.7) | 28 (4.3) | 0 | 1 (0.6) | 0 | 1 (0.6) | 2 (0.3) |
| TEAE leading to withdrawal of treatment | 23 (13.9) | 19 (11.8) | 16 (9.9) | 18 (11.3) | 76 (11.7) | 12 (7.2) | 17 (10.6) | 10 (6.2) | 8 (5.0) | 47 (7.3) |
| TEAE leading to death | 0 | 0 | 0 | 1 (0.6) | 1 (0.2) | 0 | 0 | 0 | 0 | 0 |
| TEAEs (≥3.0% for any group) | ||||||||||
| Dry mouth | 32 (19.3) | 51 (31.7) | 40 (24.8) | 40 (25.2) | 163 (25.2) | 31 (18.7) | 51 (31.7) | 40 (24.8) | 40 (25.2) | 162 (25.0) |
| Nasopharyngitis | 35 (21.1) | 39 (24.2) | 34 (21.1) | 32 (20.1) | 140 (21.6) | 0 | 0 | 0 | 0 | 0 |
| Constipation | 37 (22.3) | 27 (16.8) | 24 (14.9) | 19 (11.9) | 107 (16.5) | 33 (19.9) | 26 (16.1) | 23 (14.3) | 18 (11.3) | 100 (15.5) |
| Cystitis | 18 (10.8) | 13 (8.1) | 25 (15.5) | 10 (6.3) | 66 (10.2) | 0 | 0 | 4 (2.5) | 0 | 4 (0.6) |
| Dysuria | 8 (4.8) | 4 (2.5) | 3 (1.9) | 7 (4.4) | 22 (3.4) | 8 (4.8) | 4 (2.5) | 3 (1.9) | 7 (4.4) | 22 (3.4) |
| Back pain | 3 (1.8) | 5 (3.1) | 6 (3.7) | 4 (2.5) | 18 (2.8) | 0 | 0 | 0 | 0 | 0 |
| Contusion | 4 (2.4) | 6 (3.7) | 3 (1.9) | 5 (3.1) | 18 (2.8) | 0 | 0 | 0 | 0 | 0 |
| Abdominal discomfort | 7 (4.2) | 4 (2.5) | 4 (2.5) | 2 (1.3) | 17 (2.6) | 5 (3.0) | 2 (1.2) | 3 (1.9) | 2 (1.3) | 12 (1.9) |
| Eczema | 5 (3.0) | 2 (1.2) | 6 (3.7) | 4 (2.5) | 17 (2.6) | 1 (0.6) | 0 | 1 (0.6) | 0 | 2 (0.3) |
| Gastroesophageal reflux disease | 2 (1.2) | 6 (3.7) | 4 (2.5) | 5 (3.1) | 17 (2.6) | 0 | 3 (1.9) | 2 (1.2) | 3 (1.9) | 8 (1.2) |
| Residual urine volume increased | 6 (3.6) | 8 (5.0) | 1 (0.6) | 2 (1.3) | 17 (2.6) | 6 (3.6) | 7 (4.3) | 1 (0.6) | 2 (1.3) | 16 (2.5) |
| Pharyngitis | 6 (3.6) | 4 (2.5) | 4 (2.5) | 2 (1.3) | 16 (2.5) | 0 | 0 | 0 | 0 | 0 |
| Dermatitis contact | 3 (1.8) | 7 (4.3) | 2 (1.2) | 2 (1.3) | 14 (2.2) | 0 | 0 | 0 | 0 | 0 |
| Gastroenteritis | 3 (1.8) | 2 (1.2) | 5 (3.1) | 2 (1.3) | 12 (1.9) | 0 | 0 | 0 | 0 | 0 |
| Osteoarthritis | 5 (3.0) | 2 (1.2) | 3 (1.9) | 2 (1.3) | 12 (1.9) | 0 | 0 | 0 | 0 | 0 |
| Gastritis | 2 (1.2) | 5 (3.1) | 4 (2.5) | 0 | 11 (1.7) | 0 | 1 (0.6) | 2 (1.2) | 0 | 3 (0.5) |
| Headache | 5 (3.0) | 4 (2.5) | 0 | 2 (1.3) | 11 (1.7) | 2 (1.2) | 2 (1.2) | 0 | 1 (0.6) | 5 (0.8) |
| Vomiting | 1 (0.6) | 2 (1.2) | 5 (3.1) | 3 (1.9) | 11 (1.7) | 0 | 0 | 1 (0.6) | 0 | 1 (0.2) |
| Dizziness | 2 (1.2) | 5 (3.1) | 0 | 3 (1.9) | 10 (1.5) | 1 (0.6) | 1 (0.6) | 0 | 1 (0.6) | 3 (0.5) |
| Dental caries | 0 | 6 (3.7) | 3 (1.9) | 0 | 9 (1.4) | 0 | 0 | 0 | 0 | 0 |
| ECG QT prolonged | 1 (0.6) | 2 (1.2) | 5 (3.1) | 1 (0.6) | 9 (1.4) | 1 (0.6) | 2 (1.2) | 4 (2.5) | 1 (0.6) | 8 (1.2) |
| Osteoporosis | 1 (0.6) | 5 (3.1) | 2 (1.2) | 1 (0.6) | 9 (1.4) | 0 | 0 | 0 | 0 | 0 |
| Cataract | 1 (0.6) | 1 (0.6) | 1 (0.6) | 5 (3.1) | 8 (1.2) | 0 | 0 | 0 | 0 | 0 |
| Dyspepsia | 0 | 5 (3.1) | 1 (0.6) | 1 (0.6) | 7 (1.1) | 0 | 2 (1.2) | 1 (0.6) | 1 (0.6) | 4 (0.6) |
Data shown for the SAF (patients who received at least one dose of study drug).