GRADE summary of findings for toxicity outcomes
Quadruplet vs triplet therapy for patients with NDMM . | ||||||
---|---|---|---|---|---|---|
Outcomes . | Anticipated absolute effects∗ (95% CI) . | Relative effect (95% CI) . | No. of participants (studies) . | Certainty of the evidence (GRADE) . | Comments . | |
Risk with triplets . | Risk with quadruplets . | |||||
SAEs | 464/1000 | 482/1000 (450-520) | RR, 1.04 (0.97-1.12) | 3077 (5 studies) | ⨁⨁⨁ˆ Moderate† | Quadruplet therapy likely results in little to no difference in serious adverse effects. |
Grade 3-4 neutropenia | 244/1000 | 441/1000 (346-563) | RR, 1.81 (1.42-2.31) | 3686 (7 studies) | ⨁⨁⨁⨁ High‡ | Quadruplet therapy increases grade 3-4 neutropenia. |
Grade 3-4 thrombocytopenia | 124/1000 | 162/1000 (133-197) | RR, 1.30 (1.07-1.58) | 3686 (7 studies) | ⨁⨁⨁⨁ High | Quadruplet therapy increases grade 3-4 thrombocytopenia slightly. |
Grade 3-4 infections | 188/1000 | 229/1000 (201-261) | RR, 1.22 (1.07-1.39) | 3384 (6 studies) | ⨁⨁⨁⨁ High | Quadruplet therapy increases grade 3-4 infections slightly. |
Secondary malignancy | 53/1000 | 73/1000 (52-101) | RR, 1.37 (0.98-1.90) | 2229 (4 studies) | ⨁ˆˆˆ Very low§,|| | Quadruplet therapy likely results in little to no difference in rate of secondary malignancy. |
Rescue stem cell mobilization | 132/1000 | 240/1000 (149-386) | RR, 1.82 (1.13-2.93) | 1810 (3 RCTs) | ⨁⨁⨁ˆ Moderate‡,§ | Quadruplet therapy likely increases the need for rescue stem cell mobilization. |
Median stem cell yield | The mean median stem cell yield was 7.01 × 106. | MD 2.22 × 106 lower (2.98 lower to 1.47 lower) | NA | 1745 (2 RCTs) | ⨁⨁⨁ˆ Moderate‡ | Quadruplet therapy likely reduces median stem cell yield. |
Quadruplet vs triplet therapy for patients with NDMM . | ||||||
---|---|---|---|---|---|---|
Outcomes . | Anticipated absolute effects∗ (95% CI) . | Relative effect (95% CI) . | No. of participants (studies) . | Certainty of the evidence (GRADE) . | Comments . | |
Risk with triplets . | Risk with quadruplets . | |||||
SAEs | 464/1000 | 482/1000 (450-520) | RR, 1.04 (0.97-1.12) | 3077 (5 studies) | ⨁⨁⨁ˆ Moderate† | Quadruplet therapy likely results in little to no difference in serious adverse effects. |
Grade 3-4 neutropenia | 244/1000 | 441/1000 (346-563) | RR, 1.81 (1.42-2.31) | 3686 (7 studies) | ⨁⨁⨁⨁ High‡ | Quadruplet therapy increases grade 3-4 neutropenia. |
Grade 3-4 thrombocytopenia | 124/1000 | 162/1000 (133-197) | RR, 1.30 (1.07-1.58) | 3686 (7 studies) | ⨁⨁⨁⨁ High | Quadruplet therapy increases grade 3-4 thrombocytopenia slightly. |
Grade 3-4 infections | 188/1000 | 229/1000 (201-261) | RR, 1.22 (1.07-1.39) | 3384 (6 studies) | ⨁⨁⨁⨁ High | Quadruplet therapy increases grade 3-4 infections slightly. |
Secondary malignancy | 53/1000 | 73/1000 (52-101) | RR, 1.37 (0.98-1.90) | 2229 (4 studies) | ⨁ˆˆˆ Very low§,|| | Quadruplet therapy likely results in little to no difference in rate of secondary malignancy. |
Rescue stem cell mobilization | 132/1000 | 240/1000 (149-386) | RR, 1.82 (1.13-2.93) | 1810 (3 RCTs) | ⨁⨁⨁ˆ Moderate‡,§ | Quadruplet therapy likely increases the need for rescue stem cell mobilization. |
Median stem cell yield | The mean median stem cell yield was 7.01 × 106. | MD 2.22 × 106 lower (2.98 lower to 1.47 lower) | NA | 1745 (2 RCTs) | ⨁⨁⨁ˆ Moderate‡ | Quadruplet therapy likely reduces median stem cell yield. |
MD, mean difference; NA, not available.
Boldface values indicate statistical significance and relevance to the overall findings of the study.
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Narrow CI, but absolute risk difference is clinically significant.
Heterogeneity testing statistically significant, but all RCTs favor triplets.
Small number of events.
Indirect outcome.