Table 4. Patients who did not die during induction: summary of the grade 3/4 AEs recognised in SPC as being related to PEG-ASPa.
| SOC/event term | Grade 3+ PEG-ASP known AEs, N (%) |
|---|---|
| Gastrointestinal disorders | 2 (3) |
| Pancreatitis | 2 (3) |
| Hepatobiliary disorders | 3 (4) |
| Liver failure | 1 (1) |
| Liver dysfunction | 2 (3) |
| Immune system disorders | 3 (4) |
| Allergic reaction | 3 (4) |
| Investigations | 29 (39) |
| Lipase increased | 1 (1) |
| Serum amylase increased | 3 (4) |
| Alkaline phosphatase increased | 15 (20) |
| Aspartate aminotransferase increased | 4 (5) |
| Blood bilirubin increased | 17 (23) |
| Alanine aminotransferase increased | 10 (14) |
| GGT increased | 5 (7) |
| Metabolism and nutrition disorders | 3 (4) |
| Increased triglycerides | 1 (1) |
| Hypoalbuminaemia | 2 (3) |
| Nervous system disorders | 1 (1) |
| Intracranial haemorrhage | 1 (1) |
| Vascular disorders | 4 (5) |
| Pulmonary embolism | 1 (1) |
| Thromboembolic event | 3 (4) |
| Non-CTCAE terms | |
| Coagulation disorder | 3 (4) |
| Any liver event | 27 (36) |
| Any toxicity | 37 (50) |
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria; GGT, gamma glutamyl transpeptidase; PEG-ASP, pegylated asparaginase; SPC, Summary of Product Characteristics; SOC, System Organ Class.
a
A complete line listing of grade 3+ AE/serious AE according to CTCAE criteria with assignment of causality by both site and by trial management group is provided in Supplementary Table S1.