Table 2.
Adverse events
| Incident | Weeks 0-65 | Weeks 66-160 | Weeks 0-160 |
|---|---|---|---|
| n (%) | n (%) | n (%) | |
| TEAEs | 52 (100) | 52 (100) | 52 (100) |
| TEAEs related to burosumab | 35 (67) | 29 (56) | 38 (73) |
| TEAEs occurring in > 20% of children from weeks 0 through 160 | |||
| Headache | 27 (52) | 30 (58) | 39 (75) |
| Cough | 24 (46) | 27 (52) | 36 (69) |
| Vomiting | 20 (39) | 20 (39) | 29 (56) |
| Arthralgia | 21 (40) | 20 (39) | 28 (54) |
| Nasopharyngitis | 21 (40) | 18 (35) | 28 (54) |
| Pain in extremity | 21 (40) | 16 (31) | 27 (52) |
| Injection site reaction | 19 (37) | 13 (25) | 26 (50) |
| Oropharyngeal pain | 10 (19) | 23 (44) | 26 (50) |
| Pyrexia | 16 (31) | 20 (39) | 25 (48) |
| Upper respiratory tract infection | 18 (35) | 11 (21) | 25 (48) |
| Injection site erythema | 12 (23) | 20 (39) | 23 (44) |
| Rhinorrhea | 9 (17) | 17 (33) | 22 (42) |
| Nasal congestion | 8 (15) | 17 (33) | 20 (39) |
| Abdominal pain upper | 10 (19) | 14 (27) | 18 (35) |
| Diarrhea | 11 (21) | 15 (29) | 18 (35) |
| Ear pain | 6 (12) | 14 (27) | 18 (35) |
| Nausea | 10 (19) | 10 (19) | 17 (33) |
| Seasonal allergy | 13 (25) | 9 (17) | 17 (33) |
| Toothache | 6 (12) | 12 (23) | 17 (33) |
| Rash | 13 (25) | 2 (4) | 15 (29) |
| Sneezing | 2 (4) | 11 (21) | 12 (23) |
| Myalgia | 8 (15) | 5 (10) | 11 (21) |
| Vitamin D decreased | 7 (13) | 5 (10) | 11 (21) |
| Serious AEs | 1 (2) | 0 (0) | 1 (2) |
| AEs leading to discontinuation | 0 (0) | 0 (0) | 0 (0) |
| AEs leading to death | 0 (0) | 0 (0) | 0 (0) |
Abbreviations: AEs, adverse events; TEAE, treatment-emergent adverse event.