Table 4.
Peri-procedural treatment-emergent adverse events in patients treated with melphalan/Hepatic Delivery System (treated population)a
| Parameters | Melphalan/HDS (n = 91) n (%) |
|
|---|---|---|
| Any grade | Grade 3/4 | |
| Any peri-procedural TEAE | 80 (87.9) | 51 (56.0) |
| Anemiab | 51 (56.0) | 27 (29.7) |
| Thrombocytopeniac | 46 (50.5) | 35 (38.5) |
| Nausea | 38 (41.8) | 0 (0.0) |
| INR increased | 28 (30.8) | 8 (8.8) |
| Vomiting | 27 (29.7) | 0 (0.0) |
| Activated PTT prolonged | 26 (28.6) | 8 (8.8) |
| AST increased | 21 (23.1) | 3 (3.3) |
| Fatigue | 21 (23.1) | 0 (0.0) |
| ALT increased | 20 (22.0) | 1 (1.1) |
| Leukopeniad | 17 (18.7) | 12 (13.2) |
| Back pain | 15 (16.5) | 1 (1.1) |
| Hypocalcemia | 12 (13.2) | 3 (3.3) |
| Troponin I increased | 12 (13.2) | 2 (2.2) |
| Contusion | 10 (11.0) | 0 (0.0) |
| Pyrexia | 10 (11.0) | 0 (0.0) |
| Hypophosphatemia | 8 (8.8) | 7 (7.7) |
| Any serious TEAE | 20 (22.0) | 16 (17.6) |
| Thrombocytopeniac | 5 (5.5) | 5 (5.5) |
HDS, hepatic delivery system; TEAE, treatment-emergent adverse event; INR, international normalized ratio; PTT, partial thromboplastin time; AST, aspartate aminotransferase; ALT, alanine aminotransferase
aPeri-procedural TEAEs reported in at least 10 % of patients (any grade) or in at least 5 % of patients (grade 3/4 and serious TEAEs) in patients treated with melphalan/Hepatic Delivery System. TEAEs with onset from the procedure date to the earlier of discharge from hospital or day 3 were considered peri-procedural
bAnemia includes anemia, febrile bone marrow aplasia, anemia, normochromic normocytic anemia, and red blood cell count decreased
cThrombocytopenia includes thrombocytopenia and platelet count decreased
dLeukopenia includes leukopenia, lymphocyte count decreased, lymphopenia, and white blood cell count decreased