AESIs
| AE, n (%) . | R/I cohort n = 33 . | ND cohort n = 25 . | All patients N = 58 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Increased blood cholesterol | 3 (9.1) | 0 | 3 (12.0) | 1 (4.0) | 6 (10.3) | 1 (1.7) |
| Increased blood glucose | 2 (6.1) | 0 | 1 (4.0) | 0 | 3 (5.2) | 0 |
| Fluid retention | 2 (6.1) | 0 | 5 (20.0) | 1 (4.0) | 7 (12.1) | 1 (1.7) |
| Edema and other fluid retention | 2 (6.1) | 0 | 5 (20.0) | 1 (4.0) | 7 (12.1) | 1 (1.7) |
| Growth retardation | 2 (6.1) | 0 | 1 (4.0) | 0 | 3 (5.2) | 0 |
| Hepatotoxicity | 19 (57.6) | 9 (27.3) | 17 (68.0) | 7 (28.0) | 36 (62.1) | 16 (27.6) |
| Drug-induced liver injury | 1 (3.0) | 1 (3.0) | 0 | 0 | 1 (1.7) | 1 (1.7) |
| Hepatic transamine and bilirubin level elevations | 19 (57.6) | 8 (24.2) | 17 (68.0) | 7 (28.0) | 36 (62.1) | 15 (25.9) |
| Myelosuppression (thrombocytopenia) | 1 (3.0) | 0 | 8 (32.0) | 3 (12.0) | 9 (15.5) | 3 (5.2) |
| QT prolongation∗ | 5 (15.2) | 0 | 3 (12.0) | 0 | 8 (13.8) | 0 |
| Rash | 16 (48.5) | 5 (15.2) | 15 (60.0) | 3 (12.0) | 31 (53.4) | 8 (13.8) |
| AE, n (%) . | R/I cohort n = 33 . | ND cohort n = 25 . | All patients N = 58 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Increased blood cholesterol | 3 (9.1) | 0 | 3 (12.0) | 1 (4.0) | 6 (10.3) | 1 (1.7) |
| Increased blood glucose | 2 (6.1) | 0 | 1 (4.0) | 0 | 3 (5.2) | 0 |
| Fluid retention | 2 (6.1) | 0 | 5 (20.0) | 1 (4.0) | 7 (12.1) | 1 (1.7) |
| Edema and other fluid retention | 2 (6.1) | 0 | 5 (20.0) | 1 (4.0) | 7 (12.1) | 1 (1.7) |
| Growth retardation | 2 (6.1) | 0 | 1 (4.0) | 0 | 3 (5.2) | 0 |
| Hepatotoxicity | 19 (57.6) | 9 (27.3) | 17 (68.0) | 7 (28.0) | 36 (62.1) | 16 (27.6) |
| Drug-induced liver injury | 1 (3.0) | 1 (3.0) | 0 | 0 | 1 (1.7) | 1 (1.7) |
| Hepatic transamine and bilirubin level elevations | 19 (57.6) | 8 (24.2) | 17 (68.0) | 7 (28.0) | 36 (62.1) | 15 (25.9) |
| Myelosuppression (thrombocytopenia) | 1 (3.0) | 0 | 8 (32.0) | 3 (12.0) | 9 (15.5) | 3 (5.2) |
| QT prolongation∗ | 5 (15.2) | 0 | 3 (12.0) | 0 | 8 (13.8) | 0 |
| Rash | 16 (48.5) | 5 (15.2) | 15 (60.0) | 3 (12.0) | 31 (53.4) | 8 (13.8) |
A patient with multiple severity grades for an AE was counted only under the maximum grade. No events were reported for the following AESI group terms: cardiovascular event (including ischemic cerebrovascular events, ischemic heart disease, peripheral arterial occlusive disease, and other cardiovascular events); cardiac failure; pancreatitis, lipase, and amylase elevations; renal events; or significant bleeding (including central nervous system or gastrointestinal hemorrhage).
Medical Dictionary for Regulatory Activities preferred terms included syncope for 1 patient and QT prolonged for 7 patients (reported in Hijiya et al21).