Table 3.
Number (%) of Patients Reporting Treatment-Emergent Adverse Events with Incidence ≥5% in Any Group, On-Therapy Period, Safety Population
| Children | Adolescents | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 42) | Fluoxetine (n = 45) | Desvenlafaxine (n = 43) | Placebo (n = 70) | Fluoxetine (n = 67) | Desvenlafaxine (n = 72) | Placebo (n = 112) | Desvenlafaxine (n = 112) | Desvenlafaxine (n = 115) | |
| Any TEAE | 27 (64.3) | 29 (64.4) | 22 (51.2) | 52 (74.3) | 43 (64.2) | 47 (65.3) | 79 (70.5) | 72 (64.3) | 69 (60.0) |
| Headache | 8 (19.0) | 3 (6.7) | 5 (11.6) | 13 (18.6) | 13 (19.4) | 14 (19.4) | 21 (18.8) | 16 (14.3) | 19 (16.5) |
| Abdominal pain upper | 2 (4.8) | 1 (2.2) | 6 (14.0) | 5 (7.1) | 8 (11.9) | 9 (12.5) | 7 (6.3) | 9 (8.0) | 15 (13.0) |
| Nausea | 3 (7.1) | 4 (8.9) | 2 (4.7) | 7 (10.0) | 9 (13.4) | 6 (8.3) | 10 (8.9) | 13 (11.6) | 8 (7.0) |
| Dizziness | 3 (7.1) | 1 (2.2) | 2 (4.7) | 3 (4.3) | 2 (3.0) | 5 (6.9) | 6 (5.4) | 3 (2.7) | 7 (6.1) |
| Influenza | 0 | 2 (4.4) | 2 (4.7) | 0 | 0 | 4 (5.6) | 0 | 2 (1.8) | 6 (5.2) |
| Nasopharyngitis | 4 (9.5) | 2 (4.4) | 1 (2.3) | 4 (5.7) | 5 (7.5) | 5 (6.9) | 8 (7.1) | 7 (6.3) | 6 (5.2) |
| Upper respiratory tract infection | 2 (4.8) | 3 (6.7) | 1 (2.3) | 4 (5.7) | 1 (1.5) | 5 (6.9) | 6 (5.4) | 4 (3.6) | 6 (5.2) |
| Vomiting | 1 (2.4) | 5 (11.1) | 1 (2.3) | 3 (4.3) | 2 (3.0) | 4 (5.6) | 4 (3.6) | 7 (6.3) | 5 (4.3) |
| Diarrhea | 1 (2.4) | 0 | 4 (9.3) | 2 (2.9) | 3 (4.5) | 1 (1.4) | 3 (2.7) | 3 (2.7) | 5 (4.3) |
| Insomnia | 1 (2.4) | 1 (2.2) | 0 | 2 (2.9) | 4 (6.0) | 4 (5.6) | 3 (2.7) | 5 (4.5) | 4 (3.5) |
| Fatigue | 1 (2.4) | 3 (6.7) | 0 | 1 (1.4) | 3 (4.5) | 2 (2.8) | 2 (1.8) | 6 (5.4) | 2 (1.7) |
| Pharyngitis | 2 (4.8) | 3 (6.7) | 1 (2.3) | 0 | 1 (1.5) | 1 (1.4) | 2 (1.8) | 4 (3.6) | 2 (1.7) |
| Rash | 0 | 3 (6.7) | 0 | 0 | 1 (1.5) | 1 (1.4) | 0 | 4 (3.6) | 1 (0.9) |
| Arthralgia | 3 (7.1) | 1 (2.2) | 1 (2.3) | 1 (1.4) | 2 (3.0) | 0 | 4 (3.6) | 3 (2.7) | 1 (0.9) |
| Fall | 2 (4.8) | 4 (8.9) | 0 | 0 | 1 (1.5) | 0 | 2 (1.8) | 5 (4.5) | 0 |
| Constipation | 3 (7.1) | 0 | 0 | 1 (1.4) | 0 | 0 | 4 (3.6) | 0 | 0 |
TEAE, treatment-emergent adverse event.