N observed | 41 | 1 | 1,789 | 240 | 619 | 9 | 50 | 51 | 611 | 210 | 389 | 810 | 157 | 407 | 150 | 2,340 | 248 | 24 | 122 | 86 |
Age, years | | | | | | | | | | | | | | | | | | | | |
0-11 | 1 (2.4) | 0 (0.0) | 1,520 (85.0) | 149 (62.1) | 441 (71.2) | 0 (0.0) | 9 (18.0) | 30 (58.8) | 191 (31.3) | 123 (58.6) | 203 (52.2) | 712 (87.9) | 143 (91.1) | 292 (71.7) | 15 (10.0) | 51 (2.2) | 0 (0.0) | 4 (16.7) | 5 (4.1) | 8 (9.3) |
12-17 | 0 (0.0) | 0 (0.0) | 46 (2.6) | 38 (15.8) | 0 (0.0) | 4 (44.4) | 1 (2.0) | 3 (5.9) | 21 (3.4) | 15 (7.1) | 26 (6.7) | 27 (3.3) | 0 (0.0) | 9 (2.2) | 79 (52.7) | 71 (3.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (4.7) |
18-44 | 37 (90.2) | 0 (0.0) | 73 (4.1) | 20 (8.3) | 14 (2.3) | 2 (22.2) | 32 (64.0) | 10 (19.6) | 94 (15.4) | 40 (19.0) | 98 (25.2) | 27 (3.3) | 0 (0.0) | 9 (2.2) | 28 (18.7) | 706 (30.2) | 70 (28.2) | 13 (54.2) | 111 (91.0) | 42 (48.8) |
45-64 | 1 (2.4) | 0 (0.0) | 43 (2.4) | 1 (0.4) | 36 (5.8) | 0 (0.0) | 2 (4.0) | 5 (9.8) | 106 (17.3) | 17 (8.1) | 28 (7.2) | 6 (0.7) | 0 (0.0) | 28 (6.9) | 0 (0.0) | 592 (25.3) | 96 (38.7) | 2 (8.3) | 4 (3.3) | 20 (23.3) |
≥65 | 0 (0.0) | 0 (0.0) | 18 (1.0) | 2 (0.8) | 95 (15.3) | 0 (0.0) | 3 (6.0) | 2 (3.9) | 160 (26.2) | 2 (1.0) | 6 (1.5) | 1 (0.1) | 0 (0.0) | 50 (12.3) | 0 (0.0) | 380 (16.2) | 62 (25.0) | 5 (20.8) | 2 (1.6) | 2 (2.3) |
Sex | | | | | | | | | | | | | | | | | | | | |
Male | 29 (70.7) | 1 (100.0) | 1,053 (58.9) | 132 (55.0) | 372 (60.1) | 3 (33.3) | 27 (54.0) | 21 (41.2) | 258 (42.2) | 119 (56.7) | 182 (46.8) | 411 (50.7) | 110 (70.1) | 214 (52.6) | 38 (25.3) | 882 (37.7) | 95 (38.3) | 7 (29.2) | 83 (68.0) | 46 (53.5) |
Female | 12 (29.3) | 0 (0.0) | 687 (38.4) | 103 (42.9) | 232 (37.5) | 5 (55.6) | 21 (42.0) | 30 (58.8) | 340 (55.6) | 88 (41.9) | 196 (50.4) | 371 (45.8) | 46 (29.3) | 190 (46.7) | 111 (74.0) | 1,406 (60.1) | 141 (56.9) | 17 (70.8) | 37 (30.3) | 37 (43.0) |
Time to onset, days | 1 (1-1) | 730 (730-730) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 1 (1-1) |
Fatal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (0.7) | 0 (0.0) | 1 (0.3) | 2 (0.2) | 0 (0.0) | 1 (0.2) | 1 (0.7) | 14 (0.6) | 4 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Concomitant adverse events, % | | | | | | | | | | | | | | | | | | | | |
Coronary | 2.4 | 0.0 | 0.1 | 0.0 | 0.3 | 11.1 | 2.0 | 0.0 | 0.5 | 0.0 | 0.3 | 0.2 | 0.0 | 0.0 | 0.7 | 1.4 | 0.8 | 0.0 | 2.5 | 0.0 |
Arrhythmia | 7.3 | 0.0 | 1.0 | 0.4 | 0.8 | 11.1 | 2.0 | 5.9 | 3.3 | 3.8 | 3.3 | 0.9 | 0.0 | 2.2 | 4.0 | 4.7 | 3.6 | 4.2 | 7.4 | 1.2 |
Heart failure | 0.0 | 0.0 | 0.3 | 0.4 | 1.0 | 0.0 | 2.0 | 0.0 | 0.8 | 1.4 | 0.5 | 0.2 | 1.9 | 1.5 | 1.3 | 1.4 | 0.0 | 0.0 | 1.6 | 0.0 |
Other cardiac diseases | 0.0 | 0.0 | 0.3 | 0.4 | 0.2 | 11.1 | 0.0 | 0.0 | 0.2 | 0.0 | 0.3 | 0.1 | 0.0 | 0.7 | 1.3 | 0.6 | 0.4 | 0.0 | 1.6 | 0.0 |
Hyperthermia | 12.2 | 0.0 | 12.1 | 5.8 | 16.2 | 11.1 | 2.0 | 15.7 | 8.3 | 14.8 | 18.3 | 19.0 | 24.2 | 18.2 | 6.7 | 10.8 | 4.4 | 4.2 | 9.8 | 5.8 |
Eosinophilia | 2.4 | 0.0 | 0.3 | 0.8 | 1.8 | 0.0 | 0.0 | 0.0 | 1.6 | 0.0 | 0.8 | 0.2 | 1.9 | 0.0 | 1.3 | 4.5 | 3.2 | 4.2 | 0.0 | 0.0 |
Thrombocytopenia and leucopenia | 0.0 | 0.0 | 0.8 | 1.7 | 1.0 | 11.1 | 0.0 | 2.0 | 0.5 | 1.0 | 1.8 | 0.9 | 2.5 | 0.7 | 1.3 | 1.0 | 0.8 | 0.0 | 0.0 | 1.2 |
Pulmonary | 2.4 | 0.0 | 1.4 | 2.9 | 2.1 | 11.1 | 4.0 | 0.0 | 1.8 | 2.4 | 1.5 | 1.5 | 3.2 | 2.9 | 4.7 | 1.8 | 1.6 | 0.0 | 0.8 | 1.2 |
Infections | 7.3 | 0.0 | 3.1 | 4.2 | 4.2 | 22.2 | 4.0 | 0.0 | 3.9 | 6.7 | 10.3 | 7.0 | 7.0 | 11.8 | 5.3 | 5.5 | 1.2 | 0.0 | 4.9 | 5.8 |
Abdominal | 0.0 | 0.0 | 1.4 | 2.9 | 2.4 | 11.1 | 0.0 | 2.0 | 2.5 | 4.3 | 2.8 | 2.2 | 7.0 | 1.5 | 4.7 | 3.1 | 1.2 | 0.0 | 0.0 | 1.2 |
Hepatobiliary | 0.0 | 0.0 | 1.0 | 0.4 | 1.1 | 11.1 | 0.0 | 0.0 | 1.1 | 2.9 | 1.5 | 1.2 | 2.5 | 1.5 | 2.0 | 1.4 | 0.0 | 0.0 | 0.0 | 1.2 |
Renal | 0.0 | 0.0 | 1.1 | 0.0 | 2.4 | 22.2 | 0.0 | 2.0 | 2.5 | 2.9 | 2.6 | 1.7 | 5.1 | 2.5 | 4.0 | 1.7 | 1.6 | 0.0 | 0.0 | 1.2 |
Endocrine | 0.0 | 0.0 | 0.2 | 0.0 | 0.2 | 11.1 | 0.0 | 0.0 | 1.3 | 0.5 | 0.3 | 0.2 | 0.0 | 0.5 | 1.3 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 |
Muscular | 9.8 | 0.0 | 0.6 | 1.3 | 2.1 | 11.1 | 0.0 | 3.9 | 2.9 | 2.4 | 1.8 | 1.1 | 0.0 | 1.7 | 2.0 | 5.5 | 5.6 | 0.0 | 3.3 | 3.5 |
Neurologic | 17.1 | 0.0 | 2.6 | 2.5 | 4.2 | 11.1 | 8.0 | 0.0 | 4.9 | 5.7 | 6.4 | 4.0 | 3.8 | 6.4 | 10.7 | 14.6 | 11.7 | 8.3 | 7.4 | 3.5 |
Psychiatric | 0.0 | 0.0 | 1.7 | 0.8 | 2.6 | 11.1 | 0.0 | 0.0 | 0.8 | 1.9 | 2.8 | 1.2 | 7.0 | 1.7 | 4.0 | 2.1 | 2.0 | 0.0 | 0.0 | 0.0 |
Osteoarticular and rheumatologic | 2.4 | 0.0 | 2.1 | 3.8 | 2.3 | 11.1 | 4.0 | 3.9 | 4.1 | 5.7 | 6.7 | 3.1 | 1.9 | 3.9 | 7.3 | 5.7 | 3.6 | 0.0 | 2.5 | 7.0 |
Dermatologic | 97.6 | 100.0 | 62.5 | 80.0 | 88.2 | 77.8 | 88.0 | 66.7 | 77.7 | 91.9 | 92.5 | 86.0 | 90.4 | 92.1 | 75.3 | 81.5 | 55.6 | 45.8 | 98.4 | 74.4 |
Anaphylaxis | 0.0 | 0.0 | 1.8 | 3.8 | 2.4 | 11.1 | 2.0 | 0.0 | 2.0 | 2.4 | 3.3 | 2.0 | 3.2 | 2.5 | 0.0 | 2.6 | 1.6 | 0.0 | 1.6 | 1.2 |
Ophthalmology | 2.4 | 0.0 | 0.8 | 3.3 | 1.1 | 11.1 | 0.0 | 0.0 | 0.8 | 1.9 | 1.5 | 2.2 | 1.3 | 1.5 | 2.7 | 1.2 | 1.6 | 0.0 | 0.0 | 1.2 |