Table 4.
Summary of common (occurring in ≥ 20% of participants) treatment-emergent adverse events in pediatric clinical trials of burosumab [7, 50, 72]
| Open-label, phase 2 burosumab Q2W (N = 13) | n (%) | Open-label, dose-finding phase 2 (N = 52) | n (%) | Randomized, double-blind, placebo-controlled phase 3 | Conventional therapy (n = 32) n (%) | Burosumab Q2W (n = 29) n, (%) |
|---|---|---|---|---|---|---|
| Cough | 11 (85) | Injection site reaction | 30 (58) | Pyrexia | 6 (19) | 16 (55) |
| Pyrexia | 9 (69) | Headache | 26 (50) | Cough | 6 (19) | 15 (52) |
| Upper respiratory tract infection | 9 (69) | Cough | 23 (44) | Arthralgia | 10 (31) | 13 (45) |
| Tooth abscess | 7 (54) | Nasopharyngitis | 21 (40) | Vomiting | 8 (25) | 12 (41) |
| Rhinorrhea | 6 (46) | Pain in extremity | 21 (40) | Nasopharyngitis | 14 (44) | 11 (38) |
| Vomiting | 6 (46) | Upper respiratory tract infection | 18 (35) | Pain in extremity | 10 (31) | 11 (38) |
| Nasal congestion | 5 (38) | Vomiting | 18 (35) | Headache | 6 (19) | 10 (34) |
| Diarrhea | 4 (31) | Arthralgia | 17 (33) | Injection site erythema | 0 | 9 (31) |
| Pain in extremity | 4 (31) | Pyrexia | 16 (31) | Dental caries | 2 (6) | 9 (31) |
| Streptococcal pharyngitis | 4 (31) | Rash | 13 (25) | Tooth abscess | 3 (9) | 8 (28) |
| Arthralgia | 3 (23) | Seasonal allergy | 13 (25) | Injection site reaction | 0 | 7 (24) |
| Arthropod bite | 3 (23) | Rhinorrhea | 2 (6) | 7 (24) | ||
| Nasopharyngitis | 3 (23) | Diarrhea | 2 (6) | 7 (24) | ||
| Oral pain | 3 (23) | Vitamin D decrease | 1 (3) | 6 (21) | ||
| Skin abrasion | 3 (23) |
Abbreviation: Q2W, every 2 weeks.