Table 5.

Univariate analysis for association with more than 1 treatment-related SAE

ComparisonOdds ratio95% confidence interval, lower limit95% confidence interval, upper limitWald P value
During any treatment phase 
Mantle cell histology vs follicular 2.61 1.19 5.64 .015 
Other B-NHL histology vs follicular 0.75 0.40 1.36 .348 
Other B-NHL histology vs mantle cell 0.29 0.12 0.67 .0036 
Age, y
>65 vs ≤65 
1.20 0.71 2.05 .496 
Age, y
≥70 vs <70 
1.26 0.73 2.17 .398 
Age, y
≥80 vs <80 
1.93 0.83 4.26 .111 
Male vs female sex 0.99 0.58 1.69 .976 
Bendamustine line of treatment,
2-3 vs 1 
1.17 0.65 2.07 .602 
Bendamustine line of treatment,
≥4 vs 1 
0.94 0.33 2.32 .898 
ACE27 2-3 vs 0-1 1.60 0.89 2.81 .107 
Preinduction ECOG PS score of 1 vs 0 1.55 0.85 2.90 .1568 
Preinduction ECOG PS score of 2 vs 0 2.98 1.21 7.19 .0154 
Preinduction ECOG PS score of 3 vs 0 2.21 0.45 8.70 .2795 
Premaintenance ECOG PS score of 1 vs 0 5.27 1.95 16.87 .0021 
Premaintenance ECOG PS score of 2 vs 0 9.76 1.92 50.82 .0053 
Stage III vs II 2.34 0.66 11.03 .2207 
Stage IV vs II 2.65 0.88 11.46 .1231 
FLIPI score, moderate vs low 1.97 0.60 7.71 .2835 
FLIPI score, high vs low 2.16 0.72 8.06 .2000 
sMIPI score, moderate vs low 0.67 0.08 6.59 .7110 
sMIPI score, high vs low 1.31 0.17 12.27 .7960 
sMIPI score, not applicable 0.36 0.06 2.80 .2720 
Sex,
male vs female 
0.99 0.58 1.69 .976 
G-CSF prophylaxis, yes vs no    .02847 
Prolonged steroid use, yes vs no    .2938 
Prior fludarabine, yes vs no    .7243 
Antibiotic prophylaxis, yes vs no    .9282 
Induction phase 
Starting bendamustine dose, 50%-74% vs 100% 0.93 0.21 3.04 .91 
Starting bendamustine dose, 75%-99% vs 100% 1.35 0.54 3.08 .494 
Lymphocyte count, normal vs abnormal 0.76 0.41 1.38 .379 
Total globulins, normal vs abnormal 2.43 1.11 5.40 .0274 
Maintenance & follow-up phases 
Lymphocyte count, normal vs abnormal 0.95 0.14 3.99 .947 
Total globulins, normal vs abnormal 1.20 0.29 5.56 .806 
ComparisonOdds ratio95% confidence interval, lower limit95% confidence interval, upper limitWald P value
During any treatment phase 
Mantle cell histology vs follicular 2.61 1.19 5.64 .015 
Other B-NHL histology vs follicular 0.75 0.40 1.36 .348 
Other B-NHL histology vs mantle cell 0.29 0.12 0.67 .0036 
Age, y
>65 vs ≤65 
1.20 0.71 2.05 .496 
Age, y
≥70 vs <70 
1.26 0.73 2.17 .398 
Age, y
≥80 vs <80 
1.93 0.83 4.26 .111 
Male vs female sex 0.99 0.58 1.69 .976 
Bendamustine line of treatment,
2-3 vs 1 
1.17 0.65 2.07 .602 
Bendamustine line of treatment,
≥4 vs 1 
0.94 0.33 2.32 .898 
ACE27 2-3 vs 0-1 1.60 0.89 2.81 .107 
Preinduction ECOG PS score of 1 vs 0 1.55 0.85 2.90 .1568 
Preinduction ECOG PS score of 2 vs 0 2.98 1.21 7.19 .0154 
Preinduction ECOG PS score of 3 vs 0 2.21 0.45 8.70 .2795 
Premaintenance ECOG PS score of 1 vs 0 5.27 1.95 16.87 .0021 
Premaintenance ECOG PS score of 2 vs 0 9.76 1.92 50.82 .0053 
Stage III vs II 2.34 0.66 11.03 .2207 
Stage IV vs II 2.65 0.88 11.46 .1231 
FLIPI score, moderate vs low 1.97 0.60 7.71 .2835 
FLIPI score, high vs low 2.16 0.72 8.06 .2000 
sMIPI score, moderate vs low 0.67 0.08 6.59 .7110 
sMIPI score, high vs low 1.31 0.17 12.27 .7960 
sMIPI score, not applicable 0.36 0.06 2.80 .2720 
Sex,
male vs female 
0.99 0.58 1.69 .976 
G-CSF prophylaxis, yes vs no    .02847 
Prolonged steroid use, yes vs no    .2938 
Prior fludarabine, yes vs no    .7243 
Antibiotic prophylaxis, yes vs no    .9282 
Induction phase 
Starting bendamustine dose, 50%-74% vs 100% 0.93 0.21 3.04 .91 
Starting bendamustine dose, 75%-99% vs 100% 1.35 0.54 3.08 .494 
Lymphocyte count, normal vs abnormal 0.76 0.41 1.38 .379 
Total globulins, normal vs abnormal 2.43 1.11 5.40 .0274 
Maintenance & follow-up phases 
Lymphocyte count, normal vs abnormal 0.95 0.14 3.99 .947 
Total globulins, normal vs abnormal 1.20 0.29 5.56 .806 

Wald P values are bold if P < .05.

FLIPI, Follicular Lymphoma International Prognostic Index; PS, performance status; sMIPI, simplified Mantle Cell Lymphoma International Prognostic Index.

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