Table 2 Drug-stratified analysis
Drug substances | Methylphenidate a (5.5%; n = 1151) | Ibuprofen a (2.3%; n = 470) | Palivizumab a,b (2.0%; n = 411) | Atomoxetine a (2.0%; n = 407) | Etanercept a (1.9%; n = 389) |
|---|---|---|---|---|---|
Patients demographics | |||||
Mean age (+/− standard deviation) [years] | 11.2 (+/−3.4) | 7.9 (+/−6.0) | 0.2 (+/− 0.5) | 11.4 (+/− 3.1) | 11.4 (+/− 4.5) |
Median age (interquartile range) [years] | 11.0 (9.0–14.0) | 7.0 (2.0–14.0) | 0.0 (0.0–0.0) | 12.0 (9.0–14.0) | 12.0 (9.0–15.0) |
Male/female ratio | 3.5:1.0 | 1.0:1.0 | 1.3:1.0 | 4.2:1.0 | 0.5:1.0 |
Serious | 77.5% | 76.6% | 96.4% | 87.7% | 39.6% |
ADRs most frequently reported | |||||
1. | headache (5.3%; n = 61) | suicide attempt (13.8%; n = 65) | respiratory syncytial virus infection (40.1%; n = 165) | suicidal ideation (14.0%; n = 57) | injection site pain (16.7%; n = 65) |
2. | decreased appetite (4.7%; n = 54) | intentional overdose (11.3%; n = 53) | respiratory syncytial virus bronchiolitis (16.1%; n = 66) | aggression (12.5%; n = 51) | condition aggravated (6.9%; n = 27) |
3. | tachycardia (4.2%; n = 48) | vomiting (10.4%; n = 49) | bronchitis (8.5%; n = 35) | nausea (7.9%; n = 32) | injection site erythema (5.1%; n = 20) |
4. | tic (4.0%; n = 46) | urticaria (8.3%; n = 39) | pneumonia (7.3%; n = 30) | tachycardia (6.1%; n = 25) | drug ineffective (4.6%; n = 18) |
5. | leukopenia (3.6%; n = 41) | nausea (6.4%; n = 6.4%) | respiratory failure (6.8%; n = 28) | fatigue (5.4%; n = 22) | nasopharyngitis (4.6%; n = 18) |