Table 4 Frequencies and types of adverse events (AEs) >GII (BenMel: Bendamustine/melphalan).
AE type, number of pts (%) | Total cohort (n = 120) | Melphalan (n = 60) | BenMel (n = 60) | P value |
|---|---|---|---|---|
Gastrointestinal disorders | 61 (50.8) | 31 (51.7) | 30 (50.0) | 0.8554 |
Metabolic and nutritional disorders | 30 (25.0) | 10 (16.7) | 20 (33.3) | 0.0359 |
Cardiac and thromboembolic disorders | 8 (6.7) | 5 (8.3) | 3 (5.0) | 0.4700 |
Weight loss >10% | 5 (4.2) | 0 (0.0) | 5 (8.3) | 0.0232 |
Engraftment syndrome | 5 (4.2) | 3 (5.0) | 2 (3.3) | 0.6420 |
Respiratory | 4 (3.3) | 1 (1.7) | 3 (5.0) | 0.3117 |
Nervous system disorders | 4 (3.3) | 1 (1.7) | 3 (5,0) | 0.3117 |
Infection | 4 (3.3) | 3 (5.0) | 1 (1.7) | 0.3117 |
Renal | 3 (2.5) | 0 (0.0) | 3 (5.0) | 0.0807 |
Muscle weakness and fatigue | 2 (1.7) | 1 (1.7) | 1 (1.7) | 1.0000 |
Psychiatric disorders | 1 (0.8) | 0 (0.0) | 1 (1.7) | 1.0000 |
Hearing impairment | 1 (0.8) | 0 (0.0) | 1 (1.7) | 1.0000 |
Fever of unknown origin | 1 (0.8) | 1 (1.7) | 0 (0.0) | 0.3168 |
Total number of AEs | 129 | 56 | 73 | 0.187 |
No of patients with AEs | 79 (65.8) | 36 (60.0) | 43 (71.7) | 0.178 |
