Table 3.
MMRM overall LS mean changes from baseline through day 126 between arms
| Domain | Liso-cel, mean (95% CI) | SOC, mean (95% CI) | Difference liso-cel vs SOC, mean (95% CI) | Between-group MID |
|---|---|---|---|---|
| EORTC QLQ-C30∗ | ||||
| Global health status/QOL | 3.1 (−1.8 to 8.0) | <0.1 (−5.2 to 5.3) | 3.0 (−3.6 to 9.7) | 4 |
| Physical functioning | −2.8 (−6.8 to 1.2) | −2.2 (−6.6 to 2.3) | −0.6 (−6.2 to 5.0) | 5 |
| Role functioning | 0.4 (−5.8 to 6.7) | 1.0 (−5.6 to 7.7) | −0.6 (−9.0 to 7.8) | 6 |
| Emotional functioning | 2.2 (−2.8 to 7.2) | 7.0 (1.2-12.7) | −4.8† (−11.9 to 2.4) | 3 |
| Cognitive functioning | 2.2 (−1.5 to 5.9) | −2.1 (−6.0 to 1.8) | 4.3‡ (−0.8 to 9.4) | 3 |
| Social functioning | −1.6 (−7.3 to 4.1) | 3.0 (−3.8 to 9.8) | −4.6 (−13.0 to 3.8) | 5 |
| Fatigue | −2.0 (−7.4 to 3.5) | 3.8 (−2.2 to 9.7) | −5.7‡ (−13.2 to 1.8) | 5 |
| Nausea/vomiting | −1.2 (−4.0 to 1.5) | 2.1 (−0.7 to 4.9) | −3.4 (−7.1 to 0.4) | 3 |
| Pain | −11.1 (−16.4 to 5.9) | −15.6 (−21.2 to 9.9) | 4.4 (−2.7 to 11.6) | 6 |
| Dyspnea | 5.6 (−0.6 to 11.8) | 5.37 (−1.8 to 12.6) | 0.2 (−8.7 to 9.1) | 4 |
| Insomnia | −4.5 (−10.5 to 1.5) | −4.6 (−11.4 to 2.2) | <0.1 (−8.4 to 8.5) | 4 |
| Appetite loss | −0.9 (−6.5 to 4.7) | −2.5 (−8.2 to 3.2) | 1.6 (−5.9 to 9.1) | 5 |
| Constipation | 6.8 (2.4-11.2) | 6.1 (1.1-11.1) | 0.8 (−5.6 to 7.1) | 5 |
| Diarrhea | −3.9 (−8.7 to 0.8) | −3.4 (−8.4 to 1.6) | −0.6 (−6.9 to 5.8) | 3 |
| Financial difficulties | −2.2 (−7.1 to 2.4) | −1.0 (−6.7 to 4.7) | −1.3 (−8.4 to 5.8) | 3 |
| FACT-LymS | 1.5 (−0.3 to 3.3) | 1.6 (−0.4 to 3.7) | −0.2 (−2.7 to 2.4) | 3 |
∗
Higher scores reflect better HRQOL for the global health status/QOL domains and physical and cognitive functioning and relate to more symptoms (ie, worse HRQOL) for the individual symptom domain (ie, fatigue) of the EORTC QLQ-C30.
†
Differences in overall LS mean changes exceed the prespecified between-group MID in favor of SOC.
‡
Differences in overall LS mean changes exceed the prespecified between-group MID in favor of liso-cel.