Frequency of SCD-related events and treatment-emergent AEs
. | Treatment group . | |
---|---|---|
. | GMI-1070 (N = 43) . | Placebo (N = 33) . |
SCD-related events | ||
ACS | 6 (14.0) | 3 (9.1) |
RBC transfusion | 15 (34.9) | 17 (51.5) |
ICU stay | 0 | 1 (3) |
Death | 0 | 0 |
Readmission for VOC (14 d) | 4 (9.3) | 3 (9.1) |
Readmission for VOC (30 d) | 9 (20.9) | 7 (21.2) |
Treatment-emergent AEs | ||
Gastrointestinal disorders | 18 (41.9) | 12 (36.4) |
Rash | 6 (14.0) | 2 (6.1) |
Hepatobiliary disorders | 2 (4.7) | 2 (6.1) |
Renal/urinary disorders | 3 (7.0) | 2 (6.1) |
Pyrexia | 8 (18.6) | 6 (18.2) |
Headache | 8 (18.6) | 4 (12.1) |
. | Treatment group . | |
---|---|---|
. | GMI-1070 (N = 43) . | Placebo (N = 33) . |
SCD-related events | ||
ACS | 6 (14.0) | 3 (9.1) |
RBC transfusion | 15 (34.9) | 17 (51.5) |
ICU stay | 0 | 1 (3) |
Death | 0 | 0 |
Readmission for VOC (14 d) | 4 (9.3) | 3 (9.1) |
Readmission for VOC (30 d) | 9 (20.9) | 7 (21.2) |
Treatment-emergent AEs | ||
Gastrointestinal disorders | 18 (41.9) | 12 (36.4) |
Rash | 6 (14.0) | 2 (6.1) |
Hepatobiliary disorders | 2 (4.7) | 2 (6.1) |
Renal/urinary disorders | 3 (7.0) | 2 (6.1) |
Pyrexia | 8 (18.6) | 6 (18.2) |
Headache | 8 (18.6) | 4 (12.1) |
Values are N (%). No differences between GMI-1070 and placebo groups were statistically significant.