Table 2.

Plitidepsin-related adverse events.

ParameterPre-amendmenta,b (n = 9)Post-amendmentc (n = 36)
Grade 1Grade 2Grade 3Grade 1Grade 2Grade 3
N (%)N (%)N (%)N (%)N (%)N (%)
Nausea3 (33.3%)2 (22.2%)11 (30.6%)3 (8.3%)
Vomiting2 (22.2%)3 (8.3%)2 (5.6%)
Diarrhea1 (2.8%)1 (2.8%)1 (2.8%)
Abdominal pain2 (5.6%)
Dyspepsia2 (5.6%)
Asthenia1 (2.8%)1 (2.8%)
Anorexia1 (2.8%)
Chest discomfort---1 (2.8%)--
Temperature regulation disorder1 (2.8%)
Dysthermia1 (2.8%)
Anaphylactic reaction1 (11.1%)
Amylase increasedd1 (2.8%)
Lipase increasede1 (2.8%)
Decreased appetite1 (2.8%)
Dizziness2 (5.6%)
Dysgeusia2 (5.6%)
  • a Relevant amendment #9 was implemented in Protocol v5.0 dated 13 August 2020 (Supplemental Data 2): 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.