Summary of TRAEs by dosing cohort across all courses (safety analysis population)
| Patients, n (%) . | IM 25 mg/m2 MWF (n = 33) . | IM 37.5 mg/m2 MWF (n = 83) . | IM 25/25/50 mg/m2 MWF (n = 51) . | IM total (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|---|---|---|
| Any TRAE | 21 (64) | 66 (80) | 39 (76) | 126 (75) | 55 (90) |
| Any grade 3/4 TRAE | 14 (42) | 46 (55) | 28 (55) | 88 (53) | 38 (62) |
| Any serious TRAE∗ | 5 (15) | 28 (34) | 15 (29) | 48 (29) | 29 (48) |
| Any TRAE leading to study drug discontinuation | 2 (6) | 14 (17) | 6 (12) | 22 (13) | 20 (33) |
| Pancreatitis† | 0 | 6 (7) | 4 (8) | 10 (6) | 2 (3) |
| Allergic reactions‡ | 2 (6) | 6 (7) | 2 (4) | 10 (6) | 13 (21) |
| Increased ALT | 0 | 1 (1) | 0 | 1 (1) | 0 |
| Hyperammonemia | 0 | 1 (1) | 0 | 1 (1) | 0 |
| Nausea | 0 | 0 | 0 | 0 | 1 (2) |
| Vomiting | 0 | 0 | 0 | 0 | 2 (3) |
| Hyperammonemic encephalopathy | 0 | 0 | 0 | 0 | 1 (2) |
| Deep vein thrombosis | 0 | 0 | 0 | 0 | 1 (2) |
| Any TRAE leading to death | 0 | 0 | 0 | 0 | 0 |
| Patients, n (%) . | IM 25 mg/m2 MWF (n = 33) . | IM 37.5 mg/m2 MWF (n = 83) . | IM 25/25/50 mg/m2 MWF (n = 51) . | IM total (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|---|---|---|
| Any TRAE | 21 (64) | 66 (80) | 39 (76) | 126 (75) | 55 (90) |
| Any grade 3/4 TRAE | 14 (42) | 46 (55) | 28 (55) | 88 (53) | 38 (62) |
| Any serious TRAE∗ | 5 (15) | 28 (34) | 15 (29) | 48 (29) | 29 (48) |
| Any TRAE leading to study drug discontinuation | 2 (6) | 14 (17) | 6 (12) | 22 (13) | 20 (33) |
| Pancreatitis† | 0 | 6 (7) | 4 (8) | 10 (6) | 2 (3) |
| Allergic reactions‡ | 2 (6) | 6 (7) | 2 (4) | 10 (6) | 13 (21) |
| Increased ALT | 0 | 1 (1) | 0 | 1 (1) | 0 |
| Hyperammonemia | 0 | 1 (1) | 0 | 1 (1) | 0 |
| Nausea | 0 | 0 | 0 | 0 | 1 (2) |
| Vomiting | 0 | 0 | 0 | 0 | 2 (3) |
| Hyperammonemic encephalopathy | 0 | 0 | 0 | 0 | 1 (2) |
| Deep vein thrombosis | 0 | 0 | 0 | 0 | 1 (2) |
| Any TRAE leading to death | 0 | 0 | 0 | 0 | 0 |
TRAEs were reported as MedDRA (version 22.1) preferred terms. The severity of TRAEs was recorded using CTCAE 5.0. AEs were considered related to JZP458 if the event followed a reasonable temporal sequence from administration and fulfilled ≥1 instance of clinical evidence: the event followed a known or suspected response pattern to the study drug; the event disappeared after stopping the study drug; or the event reappeared after the study drug was restarted.
CTCAE, common terminology criteria for adverse events; MedDRA, Medical Dictionary for Regulatory Activities.
Serious TRAEs were events that led to death or were life threatening, or caused hospitalization, disability, permanent damage, or congenital anomalies/birth effects or required intervention to prevent permanent impairment, or other important medical events in which the event may jeopardize the patient and may require intervention to prevent 1 of the other outcomes.
Includes the preferred terms of pancreatitis and acute pancreatitis.
Includes the preferred terms of hypersensitivity, drug hypersensitivity, anaphylactic reactions, and infusion-related reactions.