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. Author manuscript; available in PMC: 2020 Aug 11.
Published in final edited form as: Clin Pharmacol Ther. 2017 Nov 20;103(1):67–76. doi: 10.1002/cpt.871

Table 2.

Sensitivity analysis of benefit-risk over control: ixazomib plus lenalidomide plus dexamethasone

Range of variation Basis of selection of range
Decision factor Parameter Low Expected High Factor Detail
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)