Table 2 Differences in LS mean changes from baseline for ponatinib versus imatinib (PRO-evaluable population).

From: Patient-reported outcomes in Philadelphia chromosome-positive acute lymphoblastic leukemia patients treated with ponatinib or imatinib: results from the PhALLCON trial

Domain/subscale

Ponatinib

Imatinib

Difference in LS mean change (95% CI); p†

MID

n

LS mean change (95% CI); p*

n

LS mean change (95% CI); p*

Baseline to end of induction phase

FACT-Leu

FACT-G PWB

125

−0.303 (−1.076, 0.469); 0.440

63

−1.848 (−2.947, −0.749); 0.001

1.545 (0.204, 2.885); 0.024

2

FACT-G SWB

125

−1.435 (−2.134, −0.736); <0.001

63

−0.944 (−1.938, 0.050); 0.063

−0.491 (−1.704, 0.722); 0.425

2

FACT-G EWB

125

0.424 (−0.158, 1.006); 0.152

63

0.123 (−0.708, 0.955); 0.770

0.301 (−0.717, 1.318); 0.561

2

FACT-G FWB

125

0.083 (−0.830, 0.996); 0.858

62

−0.004 (−1.317, 1.309); 0.996

0.087 (−1.515, 1.689); 0.915

2

FACT-LeuS

125

2.296 (0.937, 3.655); 0.001

63

−2.140 (−4.073, −0.207); 0.030

4.436 (2.077, 6.795); <0.001

4

FACT-Leu TOI

125

2.102 (−0.495, 4.700); 0.112

62

−4.109 (−7.836, −0.383); 0.031

6.212 (1.670, 10.753); 0.008

5

FACT-G TS

125

−1.156 (−3.361, 1.049); 0.302

62

−2.877 (−6.041, 0.287); 0.074

1.721 (−2.134, 5.576); 0.380

3

FACT-Leu TS

125

1.172 (−2.070, 4.414); 0.477

62

−5.139 (−9.790, −0.488); 0.031

6.311 (0.645, 11.978); 0.029

6

EQ-5D-5L

UK-based HUI

127

−0.034 (−0.067, −0.001); 0.042

66

−0.040 (−0.086, 0.007); 0.093

0.005 (−0.051, 0.062); 0.850

0.08

US-based HUI

127

−0.024 (−0.048, 0.000); 0.053

66

−0.027 (−0.061, 0.007); 0.119

0.003 (−0.038, 0.044); 0.884

0.08

EQ-VAS

127

0.952 (−1.953, 3.857); 0.519

66

−1.892 (−5.968, 2.183); 0.361

2.845 (−2.144, 7.834); 0.262

7

Baseline to end of consolidation phase

FACT-Leu

FACT-G PWB

101

0.437 (−0.481, 1.355); 0.349

53

−2.506 (−3.778, −1.234); <0.001

2.943 (1.373, 4.513); <0.001

2

FACT-G SWB

101

−1.226 (−2.074, −0.378); 0.005

54

−1.312 (−2.474, −0.149); 0.027

0.086 (−1.350, 1.521); 0.906

2

FACT-G EWB

101

0.232 (−0.531, 0.996); 0.549

54

−0.843 (−1.895, 0.209); 0.115

1.075 (−0.228, 2.378); 0.105

2

FACT-G FWB

101

0.224 (−0.852, 1.300); 0.681

54

−0.974 (−2.451, 0.503); 0.194

1.199 (−0.627, 3.025); 0.197

2

FACT-LeuS

101

1.465 (−0.177, 3.106); 0.080

54

−1.657 (−3.913, 0.598); 0.149

3.122 (0.327, 5.918); 0.029

4

FACT-Leu TOI

101

2.267 (−0.812, 5.347); 0.148

53

−4.981 (−9.249, −0.713); 0.022

7.248 (1.977, 12.520); 0.007

5

FACT-G TS

101

−0.298 (−2.946, 2.349); 0.824

53

−5.524 (−9.189, −1.860); 0.003

5.226 (0.708, 9.744); 0.024

3

FACT-Leu TS

101

1.266 (−2.665, 5.197); 0.526

53

−6.998 (−12.443, −1.552); 0.012

8.264 (1.543, 14.984); 0.016

6

EQ-5D-5L

UK-based HUI

103

−0.006 (−0.046, 0.034); 0.775

59

−0.051 (−0.104, 0.002); 0.058

0.045 (−0.021, 0.111); 0.178

0.08

US-based HUI

103

0.002 (−0.028, 0.032); 0.908

59

−0.035 (−0.075, 0.005); 0.086

0.037 (−0.013, 0.087); 0.150

0.08

EQ-VAS

103

5.298 (1.848, 8.748); 0.003

59

−2.490 (−7.067, 2.087); 0.284

7.788 (2.054, 13.523); 0.008

7

  1. Domains/subscales in bold are primary domains of interest. Values exceeding the MID threshold are underlined.
  2. CI confidence interval, EQ-VAS EuroQol visual analogue scale, EWB emotional well-being, FACT-G Functional Assessment of Cancer Therapy–General, FACT-Leu Functional Assessment of Cancer Therapy–Leukemia, FWB functional well-being, HUI health utility index, LeuS leukemia “additional concerns” subscale, LS least squares, MID minimal important difference, PRO patient-reported outcome, PWB physical well-being, SWB social/family well-being, TOI trial outcome index, TS total score.
  3. *Nominal p for within-group LS mean change from baseline.
  4. †Nominal p for between-group difference in LS mean change from baseline.
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