Benefit |
Estimated PFS improvement [months] |
4.42 |
5.90 |
7.38 |
Population heterogeneity |
Variation in estimated PFS of Ixazomib and
Control corresponding to ± 50% variation in proportion of
population with no prior stem cell transplant (± 0.45 months for
Ixazomib and ± 1.41 months for Control) |
Risk Death |
Severity [months] |
36.86 |
39.81 |
42.76 |
Natural history |
Variation in life expectancy for Control
corresponding to ± 50% variation in proportion of population with
stem cell transplant (± 2.95 months) |
|
Occurrence relative to control |
−0.037 |
−0.014 |
0.009 |
Exposure |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |
|
|
−0.037 |
−0.014 |
0.009 |
Attributability |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |
Nonfatal serious AEs |
Severity [months] |
0.88 |
1.32 |
2.62 |
Estimation of seriousness |
Variation of ± 1/2 grade of severity of
AE |
|
Occurrence relative to control |
−0.347 |
−0.047 |
0.253 |
Exposure |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |
|
|
−0.347 |
−0.047 |
0.253 |
Attributability |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |
Common AEs |
Severity [months] |
0.1045 |
0.1479 |
0.2779 |
Estimation of seriousness |
Variation of ± 1/2 grade of severity of
AE |
|
Occurrence relative to control |
−1.000 |
−1.680 |
−1.227 |
Exposure |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |
|
|
−1.000 |
−1.680 |
−1.295 |
Attributability |
Attributability to treatment (± 50% of
occurrence adjusted for treatment duration) |