Table 3.
Number (%) of Patients Reporting Treatment-Emergent Adverse Events with Incidence ≥5% in Any Treatment Group, On-Therapy Period, Safety Population
| Children | Adolescents | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 36) | Desvenlafaxine low exposure (n = 37) | Desvenlafaxine high exposure (n = 36) | Placebo (n = 84) | Desvenlafaxine low exposure (n = 85) | Desvenlafaxine high exposure (n = 85) | Placebo (n = 120) | Desvenlafaxine low exposure (n = 122) | Desvenlafaxine high exposure (n = 121) | |
| Any TEAE | 21 (58.3) | 24 (64.9) | 24 (66.7) | 52 (61.9) | 57 (67.1) | 57 (67.1) | 73 (60.8) | 81 (66.4) | 81 (66.9) |
| Abdominal pain, upper | 4 (11.1) | 3 (8.1) | 5 (13.9) | 5 (6.0) | 4 (4.7) | 6 (7.1) | 9 (7.5) | 7 (5.7) | 11 (9.1) |
| Accidental overdose | 1 (2.8) | 0 | 2 (5.6) | 0 | 0 | 1 (1.2) | 1 (0.8) | 0 | 3 (2.5) |
| Aggression | 0 | 2 (5.4) | 0 | 0 | 0 | 0 | 0 | 2 (1.6) | 0 |
| Blood triglycerides increased | 0 | 2 (5.4) | 0 | 0 | 0 | 0 | 0 | 2 (1.6) | 0 |
| Cough | 2 (5.6) | 1 (2.7) | 1 (2.8) | 3 (3.6) | 1 (1.2) | 2 (2.4) | 5 (4.2) | 2 (1.6) | 3 (2.5) |
| Decreased appetite | 1 (2.8) | 0 | 3 (8.3) | 5 (6.0) | 6 (7.1) | 3 (3.5) | 6 (5.0) | 6 (4.9) | 6 (5.0) |
| Diarrhea | 0 | 2 (5.4) | 2 (5.6) | 2 (2.4) | 1 (1.2) | 1 (1.2) | 2 (1.7) | 3 (2.5) | 3 (2.5) |
| Dizziness | 0 | 1 (2.7) | 0 | 3 (3.6) | 4 (4.7) | 6 (7.1) | 3 (2.5) | 5 (4.1) | 6 (5.0) |
| Dysmenorrheaa | 0 | 0 | 0 | 1 (2.1) | 1 (1.8) | 4 (7.1) | 1 (1.7) | 1 (1.4) | 4 (5.3) |
| Fatigue | 1 (2.8) | 2 (5.4) | 2 (5.6) | 1 (1.2) | 2 (2.4) | 7 (8.2) | 2 (1.7) | 4 (3.3) | 9 (7.4) |
| Feeling jittery | 0 | 0 | 2 (5.6) | 0 | 1 (1.2) | 2 (2.4) | 0 | 1 (0.8) | 4 (3.3) |
| Viral gastroenteritis | 2 (5.6) | 0 | 1 (2.8) | 0 | 2 (2.4) | 2 (2.4) | 2 (1.7) | 2 (1.6) | 3 (2.5) |
| Headache | 2 (5.6) | 8 (21.6) | 5 (13.9) | 13 (15.5) | 14 (16.5) | 20 (23.5) | 15 (12.5) | 22 (18.0) | 25 (20.7) |
| Insomnia | 0 (0) | 3 (8.1) | 3 (8.3) | 1 (1.2) | 4 (4.7) | 1 (1.2) | 1 (0.8) | 7 (5.7) | 4 (3.3) |
| Nausea | 2 (5.6) | 2 (5.4) | 4 (11.1) | 5 (6.0) | 10 (11.8) | 10 (11.8) | 7 (5.8) | 12 (9.8) | 14 (11.6) |
| Nasopharyngitis | 1 (2.8) | 3 (8.1) | 1 (2.8) | 1 (1.2) | 5 (5.9) | 6 (7.1) | 2 (1.7) | 8 (6.6) | 7 (5.8) |
| Psychomotor hyperactivity | 0 | 1 (2.7) | 3 (8.3) | 0 | 0 | 1 (1.2) | 0 | 1 (0.8) | 4 (3.3) |
| Pyrexia | 0 | 3 (8.1) | 1 (2.8) | 0 | 0 | 1 (1.2) | 0 | 3 (2.5) | 2 (1.7) |
| Skin abrasion | 0 | 0 | 2 (5.6) | 0 | 0 | 0 | 0 | 0 | 2 (1.7) |
| Upper respiratory tract infection | 1 (2.8) | 0 | 0 | 2 (2.4) | 4 (4.7) | 6 (7.1) | 3 (2.5) | 4 (3.3) | 6 (5.0) |
| Vomiting | 0 | 0 | 3 (8.3) | 4 (4.8) | 1 (1.2) | 6 (7.1) | 4 (3.3) | 1 (0.8) | 9 (7.4) |
a
Percentage calculated using number of females as denominator.
TEAE, treatment-emergent adverse event.