Table 2.
Organ System | Adverse Event | Rate in Pediatric Population (%) | Rate in Adult Population (%) | Rate in Total Population (%) |
---|---|---|---|---|
Cardiovascular events | Tachycardia | 127/1016 (12.5) | 558/986 (56.6) | 1016/3878 (26.2) |
Palpitations | 174/995 (17.5) | 578/2788 (20.7) | 853/4255 (20.0) | |
Chest pain | 154/786 (19.6) | 70/1424 (4.9) | 240/2340 (10.3) | |
Dyspnea | 134/784 (17.1) | 54/477 (11.3) | 192/1391 (13.8) | |
Arrhythmia | 7/488 (1.4) | 25/258 (9.7) | 32/746 (4.3) | |
GI events | Abdominal pain | 1691/11,637 (14.5) | 26/340 (7.6) | 1822/12,497 (14.6) |
GI upset | 83/893 (9.3) | 604/2793 (21.6) | 705/3774 (18.7) | |
Low appetite | 256/1483 (17.3) | NR | 256/1483 (17.3) | |
Increased saliva | NR | 49/350 (14.0) | 49/350 (14.0) | |
Immune response | Allergic reaction | NR | 1/258 (0.4) | 12/620 (1.9) |
MSK events | Muscle tension/pain/soreness/twitching | 1266/8803 (14.4) | 105/1018 (10.3) | 1400/9979 (14.0) |
Neurological events | Headaches | 2501/11,972 (20.9) | 392/2889 (13.6) | 3191/17,331 (18.4) |
Dizziness | 885/8875 (10.0) | 395/1130 (35.0) | 1290/10,093 (12.8) | |
Tremors | 130/1606 (8.1) | 232/1125 (20.6) | 508/4449 (11.4) | |
Slurred speech | NR | 355/1110 (32.0) | 355/1110 (32.0) | |
Walking difficulties | NR | 329/1107 (29.7) | 329/1107 (29.7) | |
Decreased coordination | NR | 270/731 (36.9) | 270/731 (36.9) | |
Visual disturbances | 31/213 (14.6) | 72/627 (11.5) | 103/840 (12.3) | |
Seizures | 2/192 (1.0) | 17/1556 (1.1) | 21/1836 (1.1) | |
Physiological events | Insomnia/sleeping related symptoms | 28,371/80,173 (35.4) | 767/3109 (24.7) | 29,445/85,373 (34.5) |
Jitteriness/restlessness/shaking hands | 37/192 (19.3) | 730/2447 (29.8) | 1164/4631 (25.1) | |
Jolt and crash | 30/488 (6.1) | 448/1362 (32.9) | 900/3979 (22.6) | |
Rapid speech | 74/214 (34.6) | 381/1106 (34.4) | 455/1320 (34.5) | |
Dehydration | 123/592 (20.8) | 80/497 (16.1) | 203/1089 (18.6) | |
Fatigue | 3/488 (0.6) | 170/781 (21.8) | 175/1396 (12.5) | |
Weakness | 172/596 (28.9) | NR | 172/596 (28.9) | |
Heat intolerance | NR | 68/429 (15.9) | 77/517 (14.9) | |
Psychological events | Stress | 24,054/68,043 (35.4) | 60/90 (66.7) | 24,114/68,133 (35.4) |
Depressive mood | 17,757/76,859 (23.1) | 60/458 (13.1) | 17,817/77,317 (23) | |
Suicidal ideation/plan/attempt | 15,278/77,004 (19.8) | NR | 15,278/77,004 (19.8) | |
Agitation/anxiety/nervousness | 2801/10,937 (25.6) | 331/1771 (18.7) | 3452/14,946 (23.1) | |
Irritability | 2489/8866 (28.1) | 62/643 (9.6) | 2733/11,385 (24) | |
Renal-related events | Increased urination | 97/592 (16.4) | 37/273 (13.6) | 381/2945 (12.9) |
Kidney pain | NR | 2/258 (0.8) | 2/258 (0.8) |
GI, gastrointestinal; MSK, musculoskeletal; NR, not reported.