Table 3 Model means of FKSI-15 item scores across all available post-baseline observations (mixed-effects model)

From: Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-α in a phase III trial: final results and geographical analysis

 

Total group

EU group

US group

US vs EU

FKSI-15 items

SU

IFN- α

Diff.

P -value

SU

IFN- α

Diff.

P -value

SU

IFN- α

Diff.

P -value

Diff. US vs diff. EU

P -value

Signs and symptoms

I am losing weight

3.56

3.35

0.21

0.0037*

3.53

3.37

0.16

0.0661

3.48

3.35

0.13

0.0661

−0.03

0.7998

I have had blood in my urine

3.98

3.98

−0.00

0.9168

3.97

3.98

−0.00

0.9628

3.97

3.98

−0.01

0.4155

−0.01

0.7304

I have a lack of energy

2.62

2.21

0.41

<0.0001*

2.56

2.26

0.30

0.0428*

2.46

2.14

0.32

0.0009*

0.01

0.9293

I feel fatigued

2.62

2.35

0.27

0.0078*

2.57

2.41

0.16

0.2643

2.45

2.19

0.26

0.0074*

0.10

0.5366

I have pain

3.06

2.92

0.14

0.0639

2.99

2.98

0.01

0.9235

3.07

2.98

0.08

0.3284

0.07

0.5531

I have bone pain

3.28

3.13

0.15

0.0819

3.21

3.17

0.04

0.7628

3.37

3.23

0.14

0.0879

0.10

0.5057

I am bothered by fevers

3.88

3.59

0.29

<0.0001*

3.86

3.63

0.23

<0.0001*

3.89

3.66

0.23

<0.0001*

−0.00

0.9939

I am bothered by side effects of treatment

2.71

2.66

0.05

0.6656

2.63

2.81

−0.17

0.2186

2.67

2.47

0.21

0.0528

0.38

0.0209*

Respiratory symptoms

I have been coughing

3.48

3.12

0.36

<0.0001*

3.38

3.21

0.17

0.0551

3.46

3.27

0.19

0.0118*

0.02

0.8518

I have been short of breath

3.35

2.98

0.37

<0.0001*

3.33

3.07

0.26

0.0066*

3.24

3.01

0.23

0.0084*

−0.02

0.8302

Quality of life

I am able to enjoy life

2.66

2.37

0.29

0.0047*

2.58

2.33

0.25

0.1096

2.96

2.64

0.31

0.0001*

0.06

0.7226

I am sleeping well

2.69

2.39

0.31

0.0030*

2.62

2.53

0.09

0.4740

2.79

2.65

0.14

0.0921

0.06

0.6902

I have a good appetite

2.33

2.04

0.29

0.0344*

2.28

1.88

0.40

0.0322*

2.58

2.36

0.23

0.0512

−0.18

0.4050

I am able to work

2.30

1.90

0.40

<0.0001*

2.21

1.92

0.29

0.019*

2.57

2.35

0.22

0.0328*

−0.07

0.6267

Emotional symptom

I worry that my condition will get worse

2.68

2.55

0.13

0.0969

2.59

2.46

0.13

0.269

2.82

2.63

0.19

0.0241*

0.06

0.6405

  1. Abbreviations: SU=sunitinib; IFN-α=interferon-alfa; Diff.=sunitinib vs IFN-α; *Significant P-values (P<0.05).
  2. FKSI-15=Functional Assessment of Cancer Therapy–Kidney Symptom Index15 item; the nine bold items make up the Disease-Related Symptoms subscale (FKSI-DRS).
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