| PBO (n = 332) | ACL400/FOR12 FDC (n = 335) | ACL400/FOR6 FDC (n = 333) | ACL400 (n = 337) | FOR 12 (n = 332) |
---|---|---|---|---|---|
Patients with ≥1 TEAE, n (%) | 181 (54.5) | 215 (64.2) | 203 (61.0) | 210 (62.3) | 189 (56.9) |
TEAEs by preferred term, n (%) | Â | Â | Â | Â | Â |
Coughb | 12 (3.6) | 17 (5.1) | 13 (3.9) | 7 (2.1) | 10 (3.0) |
Headacheb | 11 (3.3) | 16 (4.8) | 14 (4.2) | 13 (3.9) | 12 (3.6) |
Nasopharyngitis | 12 (3.6) | 16 (4.8) | 17 (5.1) | 12 (3.9) | 22 (6.6) |
Urinary tract infectionb,c | 10 (3.0) | 15 (4.5) | 7 (2.1) | 11 (3.3) | 9 (2.7) |
Back pain | 9 (2.7) | 10 (3.0) | 5 (1.5) | 4 (1.2) | 6 (1.8) |
Upper respiratory tract infection | 5 (1.5) | 10 (3.0) | 13 (3.9) | 11 (3.3) | 9 (2.7) |
Diarrhea | 8 (2.4) | 9 (2.7) | 10 (3.0) | 9 (2.7) | 6 (1.8) |
Muscle spasmsb | 3 (0.9) | 9 (2.7) | 4 (1.2) | 2 (0.6) | 6 (1.8) |
Sinusitis | 7 (2.1) | 9 (2.7) | 8 (2.4) | 12 (3.6) | 6 (1.8) |
Dry mouthc | 1 (0.3) | 8 (2.4) | 5 (1.5) | 2 (0.6) | 3 (0.9) |
Tooth abscess | 2 (0.6) | 8 (2.4) | 2 (0.6) | 2 (0.6) | 0 |
Musculoskeletal pain | 2 (0.6) | 7 (2.1) | 0 | 2 (0.6) | 3 (0.9) |
Oropharyngeal pain | 10 (3.0) | 7 (2.1) | 6 (1.8) | 4 (1.2) | 6 (1.8) |
Dizziness | 7 (2.1) | 6 (1.8) | 4 (1.2) | 5 (1.5) | 8 (2.4) |
Insomniab | 2 (0.6) | 6 (1.8) | 3 (0.9) | 3 (0.9) | 9 (2.7) |
Dyspnea | 6 (1.8) | 5 (1.5) | 11 (3.3) | 6 (1.8) | 3 (0.9) |
Nausea | 4 (1.2) | 5 (1.5) | 15 (4.5) | 12 (3.6) | 14 (4.2) |
Hypertensionb | 6 (1.8) | 4 (1.2) | 9 (2.7) | 10 (3.0) | 9 (2.7) |
Constipationb,c | 6 (1.8) | 3 (0.9) | 4 (1.2) | 7 (2.1) | 4 (1.2) |
Pain in extremity | 0 | 3 (0.9) | 3 (0.9) | 7 (2.1) | 2 (0.6) |
Vomiting | 2 (0.6) | 3 (0.9) | 7 (2.1) | 5 (1.5) | 3 (0.9) |
Fatigue | 8 (2.4) | 2 (0.6) | 6 (1.8) | 4 (1.2) | 7 (2.1) |
ÎĽgastroenteritis viral | 8 (2.4) | 2 (0.6) | 5 (1.5) | 3 (0.9) | 2 (0.6) |