Table 4.
Summary of adverse events in the safety analysis set
| Patients with GL (N=66)
|
||
|---|---|---|
| Adverse event, n (%) | Acquired (n=21) | Congenital (n=45) |
| ≥1 TEAE | 21 (100.0) | 38 (84.4) |
| Drug-related TEAE | 11 (52.4) | 21 (46.7) |
| Severe TEAE | 14 (66.7) | 15 (33.3) |
| Drug-related severe TEAE | 2 (9.5) | 5 (11.1) |
| Treatment-emergent SAE | 11 (52.4) | 12 (26.7) |
| Drug-related treatment-emergent SAE | 1 (4.8) | 2 (4.4) |
| TEAE leading to study drug discontinuation | 2 (9.5) | 3 (6.7) |
| Pancreatitis and shock, subsequent cardiac arresta | 0 (0.0) | 1 (2.2) |
| Peripheral T-cell lymphoma | 1 (4.8) | 0 (0.0) |
| Progressive end-stage liver disease | 1 (4.8) | 0 (0.0) |
| Renal failure | 1 (2.2) | |
| Worsening of TGs (increased)/worsening glycemic control | 0 (0.0) | 1 (2.2) |
| On-study deaths | 1 (4.8) | 2 (4.4) |
| Pancreatitis and shock, subsequent cardiac arresta | 0 (0.0) | 1 (2.2) |
| Progressive end-stage liver disease | 1 (4.8) | 0 (0.0) |
| Renal failure | 0 (0.0) | 1 (2.2) |
| TEAE by preferred term (≥10% incidence)b | ||
| Decreased weight | 7 (33.3) | 10 (22.2) |
| Abdominal pain | 4 (19.0) | 7 (15.6) |
| Hypoglycemia | 4 (19.0) | 6 (13.3) |
| Decreased appetite | 2 (9.5) | 6 (13.3) |
| Headache | 3 (14.3) | 5 (11.1) |
a
Patient was hospitalized with a diagnosis of pancreatitis, did not receive metreleptin during hospitalization, and died after cardiac arrest on day 3 of hospitalization.
b
Medical Dictionary for Regulatory Activities, version 19.0.
GL generalized lipodystrophy, SAE serious adverse event, TEAE treatment-emergent adverse event, TGs triglycerides.