Table 2.
Plitidepsin-related adverse events.
| Parameter | Pre-amendmenta,b (n = 9) | Post-amendmentc (n = 36) | ||||
|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
| N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
| Nausea | 3 (33.3%) | 2 (22.2%) | — | 11 (30.6%) | 3 (8.3%) | — |
| Vomiting | 2 (22.2%) | — | — | 3 (8.3%) | 2 (5.6%) | — |
| Diarrhea | — | — | — | 1 (2.8%) | 1 (2.8%) | 1 (2.8%) |
| Abdominal pain | — | — | — | 2 (5.6%) | — | — |
| Dyspepsia | — | — | — | 2 (5.6%) | — | — |
| Asthenia | — | — | — | 1 (2.8%) | 1 (2.8%) | — |
| Anorexia | — | — | — | 1 (2.8%) | — | — |
| Chest discomfort | - | - | - | 1 (2.8%) | - | - |
| Temperature regulation disorder | — | — | — | 1 (2.8%) | — | — |
| Dysthermia | — | — | — | 1 (2.8%) | — | — |
| Anaphylactic reaction | — | — | 1 (11.1%) | — | — | — |
| Amylase increasedd | — | — | — | — | 1 (2.8%) | — |
| Lipase increasede | — | — | — | — | 1 (2.8%) | — |
| Decreased appetite | — | — | — | — | 1 (2.8%) | — |
| Dizziness | — | — | — | 2 (5.6%) | — | — |
| Dysgeusia | — | — | — | 2 (5.6%) | — | — |
a
Relevant amendment #9 was implemented in Protocol v5.0 dated 13 August 2020 (Supplemental Data 2 (42.9KB, docx) ): It modified prophylactic medication before plitidepsin infusion to add ondansetron 8 mg IV slow infusion and changed the route of administration of dexamethasone, from oral to IV. The dose of dexamethasone was 8 mg (calculated as 8 mg dexamethasone phosphate, which is equivalent to 6.6 mg dexamethasone base).
b
25 plitidepsin IV infusions.
c
108 plitidepsin IV infusions.
d
Short lasting, 5 min, retro sternal low intensity pain during first day IV infusion: self-resolved plitidepsin infusion completed days 1, 2, and 3.
e
Same patient, onset day 2 plitidepsin, self-resolved in 48 h.