AEs and SAEs observed in enrolled study patients
. | SAEs (total 14 SAEs in 10 patients) . | |
---|---|---|
IQ (n = 23) . | Placebo (n = 23) . | |
(8 SAEs in 6 patients) . | (6 SAEs in 4 patients) . | |
SCA with VOC | 5 | 4∗ (1 had 2 VOCs) |
COVID-19 | 1∗ (also had SCA with VOC) | 0 |
Lung infection | 0 | 1∗ (also had SCA with VOC) |
Priapism | 1∗ (also had SCA with VOC) | 0 |
Retinal detachment | 1 | 0 |
AEs (total 21 AEs in 15 patients) | ||
10 AEs in 8 patients | 11 AEs in 7 patients | |
SCA with VOC | 2 | 2 |
Chronic sickle cell pain | 1 | 0 |
General disorder: pain (not otherwise specified) | 0 | 1 |
Infections and infestations: Other specify: COVID-19 | 1 | 1 |
CPK increased | 1 | 1∗ (also had COVID-19) |
Gallbladder pain | 1 | 0 |
Rash acneiform | 1 | 0 |
Reproductive system and breast disorders: Penile pain | 1 | 0 |
Abdominal pain | 1∗ (also had SCA with VOC) | 0 |
Colitis | 1∗ (also had gallbladder pain) | 0 |
Bloating | 0 | 1 |
Headache | 0 | 1∗ (also had bloating) |
Blurred vision | 0 | 1 |
Retinopathy | 0 | 1∗ (also had blurred vision and dysmenorrhea) |
Dysmenorrhea | 0 | 1∗ (also had retinopathy and blurred vision) |
Diarrhea | 0 | 1 |
. | SAEs (total 14 SAEs in 10 patients) . | |
---|---|---|
IQ (n = 23) . | Placebo (n = 23) . | |
(8 SAEs in 6 patients) . | (6 SAEs in 4 patients) . | |
SCA with VOC | 5 | 4∗ (1 had 2 VOCs) |
COVID-19 | 1∗ (also had SCA with VOC) | 0 |
Lung infection | 0 | 1∗ (also had SCA with VOC) |
Priapism | 1∗ (also had SCA with VOC) | 0 |
Retinal detachment | 1 | 0 |
AEs (total 21 AEs in 15 patients) | ||
10 AEs in 8 patients | 11 AEs in 7 patients | |
SCA with VOC | 2 | 2 |
Chronic sickle cell pain | 1 | 0 |
General disorder: pain (not otherwise specified) | 0 | 1 |
Infections and infestations: Other specify: COVID-19 | 1 | 1 |
CPK increased | 1 | 1∗ (also had COVID-19) |
Gallbladder pain | 1 | 0 |
Rash acneiform | 1 | 0 |
Reproductive system and breast disorders: Penile pain | 1 | 0 |
Abdominal pain | 1∗ (also had SCA with VOC) | 0 |
Colitis | 1∗ (also had gallbladder pain) | 0 |
Bloating | 0 | 1 |
Headache | 0 | 1∗ (also had bloating) |
Blurred vision | 0 | 1 |
Retinopathy | 0 | 1∗ (also had blurred vision and dysmenorrhea) |
Dysmenorrhea | 0 | 1∗ (also had retinopathy and blurred vision) |
Diarrhea | 0 | 1 |
CPK, creatinine phosphokinase.
Multiple events in a single patient.