Most common TEAEs
| TEAE . | No. of patients with TEAEs (%) . | |
|---|---|---|
| All grades (≥10%) . | Grade ≥3 . | |
| VOC | 10 (66.7) | 10 (66.7) |
| Estradiol decreased | 8 (53.3) | 0 (0) |
| Estrone decreased | 7 (46.7) | 0 (0) |
| Testosterone increased, total | 6 (40) | 0 (0) |
| Arthralgia | 5 (33.3) | 0 (0) |
| Cough | 5 (33.3) | 0 (0) |
| COVID-19 infection | 5 (33.3) | 1 (6.7) |
| ALT increased | 4 (26.7) | 0 (0) |
| Bloating | 4 (26.7) | 0 (0) |
| Influenza-like symptoms | 4 (26.7) | 0 (0) |
| Fracture∗ | 4 (26.7) | 1 (6.7) |
| Lung infection | 4 (26.7) | 4 (26.7) |
| Pain in extremity | 4 (26.7) | 0 (0) |
| Upper respiratory infection | 4 (26.7) | 0 (0) |
| Back pain | 3 (20) | 2 (13.3) |
| CPK increased | 3 (20) | 1 (6.7) |
| Creatinine increased | 3 (20) | 0 (0) |
| Dehydration | 3 (20) | 0 (0) |
| Edema limbs | 3 (20) | 0 (0) |
| Fall | 3 (20) | 0 (0) |
| Headache | 3 (20) | 0 (0) |
| Hypertriglyceridemia | 3 (20) | 0 (0) |
| Insomnia | 3 (20) | 0 (0) |
| Lymph node pain | 3 (20) | 0 (0) |
| Increased appetite | 3 (20) | 0 (0) |
| Osteoporosis | 3 (20) | 0 (0) |
| Pain | 3 (20) | 1 (6.7) |
| Skin ulceration | 3 (20) | 0 (0) |
| Allergic reaction | 2 (13.3) | 0 (0) |
| Anorexia | 2 (13.3) | 0 (0) |
| Belching | 2 (13.3) | 0 (0) |
| Bilirubin increased (direct) | 2 (13.3) | 0 (0) |
| Chest wall pain | 2 (13.3) | 0 (0) |
| Chills | 2 (13.3) | 0 (0) |
| Diarrhea | 2 (13.3) | 0 (0) |
| Dry mouth | 2 (13.3) | 0 (0) |
| Hypomagnesemia | 2 (13.3) | 0 (0) |
| Laceration | 2 (13.3) | 1 (6.7) |
| Nasal congestion | 2 (13.3) | 0 (0) |
| Neutrophil count decreased | 2 (13.3) | 0 (0) |
| Noncardiac chest pain | 2 (13.3) | 0 (0) |
| Productive cough | 2 (13.3) | 0 (0) |
| Superficial thrombophlebitis | 2 (13.3) | 0 (0) |
| Testosterone deficiency | 2 (13.3) | 0 (0) |
| Toothache | 2 (13.3) | 0 (0) |
| Vaccination complication | 2 (13.3) | 0 (0) |
| Vertigo | 2 (13.3) | 0 (0) |
| TEAE . | No. of patients with TEAEs (%) . | |
|---|---|---|
| All grades (≥10%) . | Grade ≥3 . | |
| VOC | 10 (66.7) | 10 (66.7) |
| Estradiol decreased | 8 (53.3) | 0 (0) |
| Estrone decreased | 7 (46.7) | 0 (0) |
| Testosterone increased, total | 6 (40) | 0 (0) |
| Arthralgia | 5 (33.3) | 0 (0) |
| Cough | 5 (33.3) | 0 (0) |
| COVID-19 infection | 5 (33.3) | 1 (6.7) |
| ALT increased | 4 (26.7) | 0 (0) |
| Bloating | 4 (26.7) | 0 (0) |
| Influenza-like symptoms | 4 (26.7) | 0 (0) |
| Fracture∗ | 4 (26.7) | 1 (6.7) |
| Lung infection | 4 (26.7) | 4 (26.7) |
| Pain in extremity | 4 (26.7) | 0 (0) |
| Upper respiratory infection | 4 (26.7) | 0 (0) |
| Back pain | 3 (20) | 2 (13.3) |
| CPK increased | 3 (20) | 1 (6.7) |
| Creatinine increased | 3 (20) | 0 (0) |
| Dehydration | 3 (20) | 0 (0) |
| Edema limbs | 3 (20) | 0 (0) |
| Fall | 3 (20) | 0 (0) |
| Headache | 3 (20) | 0 (0) |
| Hypertriglyceridemia | 3 (20) | 0 (0) |
| Insomnia | 3 (20) | 0 (0) |
| Lymph node pain | 3 (20) | 0 (0) |
| Increased appetite | 3 (20) | 0 (0) |
| Osteoporosis | 3 (20) | 0 (0) |
| Pain | 3 (20) | 1 (6.7) |
| Skin ulceration | 3 (20) | 0 (0) |
| Allergic reaction | 2 (13.3) | 0 (0) |
| Anorexia | 2 (13.3) | 0 (0) |
| Belching | 2 (13.3) | 0 (0) |
| Bilirubin increased (direct) | 2 (13.3) | 0 (0) |
| Chest wall pain | 2 (13.3) | 0 (0) |
| Chills | 2 (13.3) | 0 (0) |
| Diarrhea | 2 (13.3) | 0 (0) |
| Dry mouth | 2 (13.3) | 0 (0) |
| Hypomagnesemia | 2 (13.3) | 0 (0) |
| Laceration | 2 (13.3) | 1 (6.7) |
| Nasal congestion | 2 (13.3) | 0 (0) |
| Neutrophil count decreased | 2 (13.3) | 0 (0) |
| Noncardiac chest pain | 2 (13.3) | 0 (0) |
| Productive cough | 2 (13.3) | 0 (0) |
| Superficial thrombophlebitis | 2 (13.3) | 0 (0) |
| Testosterone deficiency | 2 (13.3) | 0 (0) |
| Toothache | 2 (13.3) | 0 (0) |
| Vaccination complication | 2 (13.3) | 0 (0) |
| Vertigo | 2 (13.3) | 0 (0) |
CPK, creatine phosphokinase.
All fractures were the result of a traumatic event that took place. One fracture was classified as grade 3 because there was also an accompanying laceration at the fracture site that required suturing. Also, of note, 3 of 4 fractures took place in the beginning of the study, just 1 to 2 months after the start of mitapivat.