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Table 1 Change in patient-reported outcomes – titration period

From: Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain

Instrument All patients ITT patients
Mean change p-value Mean change p-value
Short Form-36v2 Health Surveya
 Physical Functioning 6.7 <0.0001 8.0 <0.0001
 Role-Physical 7.7 <0.0001 9.1 <0.0001
 Bodily Pain 9.8 <0.0001 11.6 <0.0001
 General Health 2.3 <0.0001 3.1 <0.0001
 Vitality 4.6 <0.0001 5.8 <0.0001
 Social Functioning 5.0 <0.0001 7.0 <0.0001
 Role-Emotional 3.4 <0.0001 4.7 <0.0001
 Mental Health 2.3 <0.0001 3.5 <0.0001
 Physical Component Score 8.2 <0.0001 9.6 <0.0001
 Mental Component Score 1.6 0.0026 2.9 <0.0001
EuroQol-5 Dimensions 3-Levelb
 Summary Index 0.12 <0.0001 0.14 <0.0001
 Visual Analog Scale 8.16 <0.0001 9.84 <0.0001
Work Productivity and Activity Impairment Questionnaire: Specific Health Problemc
 Percentage work time missed due to low back pain −1.3 0.3822 −4.9 0.0017
 Percentage impairment while working due to low back pain −22.4 <0.0001 −25.9 <0.0001
 Percentage overall work impairment due to low back pain −21.6 <0.0001 −26.9 <0.0001
 Percentage activity impairment due to low back pain −27.2 <0.0001 −32.0 <0.0001
  1. ITT intent to treat
  2. aHigher scores indicate a better health-related quality of life. bHigher scores indicate a better health. cHigher scores indicate less productivity/greater impairment