Table 1 Most commonly reported adverse events in PATRO Children (incidence > 7.0) and PATRO Adults (incidence > 10.0)
MedDRA dictionary preferred term | Maximum intensity | Total patients n (%) | Incidencea | |||
|---|---|---|---|---|---|---|
Mild n (%) | Moderate n (%) | Severe n (%) | Missing n (%) | |||
PATRO Children | ||||||
Nasopharyngitis | 13 (9.6) | 3 (2.2) | 0 (0.0) | 0 (0.0) | 16 (11.8) | 31.70 |
Ear infection | 1 (0.7) | 4 (2.9) | 0 (0.0) | 0 (0.0) | 5 (3.7) | 9.91 |
Varicella | 2 (1.5) | 2 (1.5) | 0 (0.0) | 1 (0.7) | 5 (3.7) | 9.91 |
Viral infection | 4 (2.9) | 1 (0.7) | 0 (0.0) | 0 (0.0) | 5 (3.7) | 9.91 |
Headache | 1 (0.7) | 3 (2.2) | 0 (0.0) | 0 (0.0) | 4 (2.9) | 7.93 |
Pneumonia | 1 (0.7) | 3 (2.2) | 0 (0.0) | 0 (0.0) | 4 (2.9) | 7.93 |
Vomiting | 3 (2.2) | 1 (0.7) | 0 (0.0) | 0 (0.0) | 4 (2.9) | 7.93 |
PATRO Adults | ||||||
Fatigue | 20 (6.8) | 6 (2.0) | 0 (0.0) | 0 (0.0) | 26 (8.9) | 23.82 |
Arthralgia | 13 (4.4) | 3 (1.0) | 0 (0.0) | 1 (0.3) | 17 (5.8) | 15.58 |
Headache | 9 (3.1) | 4 (1.4) | 0 (0.0) | 0 (0.0) | 13 (4.4) | 11.91 |
Nasopharyngitis | 11 (3.8) | 2 (0.7) | 0 (0.0) | 0 (0.0) | 13 (4.4) | 11.91 |
Dizziness | 9 (3.1) | 1 (0.3) | 2 (0.7) | 0 (0.0) | 12 (4.1) | 11.0 |
Neoplasm progression | 1 (0.3) | 4 (1.4) | 7 (2.4) | 0 (0.0) | 12 (4.1) | 11.0 |
Osteopenia | 12 (4.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (4.1) | 11.0 |
Edema peripheral | 7 (2.4) | 3 (1.0) | 1 (0.3) | 0 (0.0) | 11 (3.8) | 10.08 |