TABLE 2.
Pooled incidence of treatment-emergent adverse events.
| AEs | Treatment | All grades | Grades≥3 | ||||
|---|---|---|---|---|---|---|---|
| Included study | Pooled rate (95%Cl) | p-value | Included study | Pooled rate (95%Cl) | p-value | ||
| Hematological | SEL + DEX + PIs | 4 | 35%, 95%CI (28%,42%) | — | 4 | 0.31%,95%CI (0.22%,40%) | — |
| SEL + DEX | 2 | 49%, 95%CI (41%,58%) | 2 | 28%, 95%CI (18%,39%) | |||
| Overall | 6 | 45%, 95%CI (36%,45%) | 6 | 30%, 95%CI (23%,36%) | |||
| Thrombocytopenia | SEL + DEX + PIs | 4 | 64%, 95%CI (53%,76%) | 0.19 | 4 | 52%, 95%CI (38%,67%) | 0.41 |
| SEL + DEX | 2 | 73%, 95%CI (67%,79%) | 2 | 59%, 95%CI (52%,66%) | |||
| Overall | 6 | 68%, 95%CI (60%,76%) | 6 | 54%, 95%CI (44%,65%) | |||
| Anemia | SEL + DEX + PIs | 4 | 45%, 95%CI (26%,65%) | 0.31 | 4 | 16%, 95%CI (11%,21%) | 0.02 |
| SEL + DEX | 2 | 59%, 95%CI (41%,77%) | 2 | 36%, 95%CI (20%,52%) | |||
| Overall | 6 | 50%, 95%CI (34%,66%) | 6 | 25%, 95%CI (14%,36%) | |||
| Lymphopenia | SEL + DEX + PIs | 1 | 52%, 95%CI (31%,74%) | — | 1 | 33%, 95%CI (13%,53%) | — |
| SEL + DEX | 2 | 18%, 95%CI (12%,23%) | 2 | 11%, 95%CI (7%,16%) | |||
| Overall | 3 | 25%, 95%CI (12%,39%) | 3 | 14%, 95%CI (6%,21%) | |||
| Neutropenia | SEL + DEX + PIs | 4 | 24%, 95%CI (13%,34%) | 0.07 | 4 | 21%, 95%CI (8%,34%) | 0.93 |
| SEL + DEX | 2 | 36%, 95%CI (28%,44%) | 2 | 22%, 95%CI (16%,27%) | |||
| Overall | 6 | 29%, 95%CI (18%,40%) | 6 | 21%, 95%CI (13%,29%) | |||
| Leukopenia | SEL + DEX + PIs | 0 | — | — | 0 | — | — |
| SEL + DEX | 2 | 35%, 95%CI (29%,42%) | 2 | 14%, 95%CI (9%,19%) | |||
| Overall | 2 | 35%, 95%CI (29%,42%) | 2 | 14%, 95%CI (9%,19%) | |||
| Non-hematological | SEL + DEX + PIs | 35%, 95%CI (28%,42%) | - | 5%, 95%CI (3%,7%) | - | ||
| SEL + DEX | 49%, 95%CI (41%,58%) | 8%, 95%CI (5%,11%) | |||||
| Overall | 40%, 95%CI (34%,47%) | 30%, 95%CI (23%,36%) | |||||
| Fatigue | SEL + DEX + PIs | 4 | 59%, 95%CI (41%,77%) | 0.34 | 4 | 13%, 95%CI (9%,17%) | 0.04 |
| SEL + DEX | 2 | 69%, 95%CI (59%,79%) | 2 | 20%, 95%CI (10%,30%) | |||
| Overall | 6 | 62%, 95%CI (49%,76%) | 6 | 16%, 95%CI (12%,20%) | |||
| Nausea | SEL + DEX + PIs | 4 | 52%, 95%CI (46%,58%) | <0.00001 | 3 | 7%, 95%CI (4%,10%) | 0.52 |
| SEL + DEX | 2 | 72%, 95%CI (66%,78) | 2 | 9%, 95%CI (5%,13%) | |||
| Overall | 6 | 61%, 95%CI (51%,72%) | 5 | 8%, 95%CI (5%,10%) | |||
| Decreased appetite | SEL + DEX + PIs | 3 | 33%, 95%CI (6%,60%) | 0.14 | 2 | 3%, 95%CI (1%,6%) | 0.86 |
| SEL + DEX | 2 | 53%, 95%CI (47%,60%) | 2 | 4%, 95%CI (1%,6%) | |||
| Overall | 5 | 41%, 95%CI (22%,60%) | 4 | 3%, 95%CI (2%,5%) | |||
| Hyponatremia | SEL + DEX + PIs | 3 | 12%, 95%CI (4%,21%) | <0.00001 | 2 | 5%, 95%CI (−0%,10%) | p < 0.0001 |
| SEL + DEX | 2 | 39%, 95%CI (32%,45%) | 2 | 22%, 95%CI (16%,27%) | |||
| Overall | 5 | 25%, 95%CI (10%,40%) | 4 | 13%, 95%CI (3%,23%) | |||
| Dyspnoea | SEL + DEX + PIs | 2 | 29%, 95%CI (−13%,72%) | — | 2 | 1%, 95%CI (-0%,2%) | — |
| SEL + DEX | 1 | 22%, 95%CI (15%,29% | 1 | 4%, 95%CI (1%,8%) | |||
| Overall | 3 | 24%, 95%CI (8%,40%) | 3 | 2%, 95%CI (-1%,5%) | |||
| Diarrhea | SEL + DEX + PIs | 4 | 35%, 95%CI (27%,44%) | 0.09 | 2 | 6%, 95%CI (3%,9%) | 0.91 |
| SEL + DEX | 2 | 45%, 95%CI (38%,51%) | 3 | 6%, 95%CI (3%,10%) | |||
| Overall | 6 | 39%, 95%CI (32%,46%) | 5 | 6%, 95%CI (4%,9%) | |||
| Vomiting | SEL + DEX + PIs | 4 | 23%, 95%CI (18%,28%) | <0.0001 | 3 | 4%, 95%CI (1%,66%) | 0.82 |
| SEL + DEX | 2 | 41%, 95%CI (34%,47%) | 2 | 3%, 95%CI (1%,6%) | |||
| Overall | 6 | 32%, 95%CI (22%,41%) | 5 | 4%, 95%CI (2%,5%) | |||
| weight loss | SEL + DEX + PIs | 3 | 17%, 95%CI (3%,31%) | 0.03 | 1 | 2%, 95%CI (0%,4%) | — |
| SEL + DEX | 2 | 42%, 95%CI (25%,59%) | 2 | 1%, 95%CI (-0%,2%) | |||
| Overall | 5 | 27%, 95%CI (12%,41%) | 3 | 1%, 95%CI (0%,2%) | |||
Bold values indicates the classification of the adverse events.