| Primary | Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours) | Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 3 Days (72 hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00034.8± 134.18
- OG00140.5± 155.41
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Tapentadol IR versus Oxycodone IR | ANCOVA | | 0.5265 | Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables. | Least square mean difference | 9.0 | Standard Error of the Mean | 14.2 | 2-Sided | 95 | -18.9 | 36.9 | | | | Yes | Non-Inferiority or Equivalence | Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance. |
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| Secondary | Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline | From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM. | Modified Intent-to-Treat Population | Posted | | Median | 95% Confidence Interval | Hours | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline | From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM. | Modified Intent-to-Treat Population | Posted | | Median | 95% Confidence Interval | Hours | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of 30% Responder Rate (With Imputation) on Day 3 | The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward. | Modified Intent-to-Treat Population | Posted | | Number | | percentage of participants | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of 30% Responder Rate (With Imputation) on Day 7 | The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward. | Modified Intent-to-Treat Population | Posted | | Number | | percentage of participants | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of 50% Responder Rate (With Imputation) on Day 3 | The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward. | Modified Intent-to-Treat Population | Posted | | Number | | percentage of participants | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of 50% Responder Rate (With Imputation) on Day 7 | The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward. | Modified Intent-to-Treat Population | Posted | | Number | | percentage of participants | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours) | Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 2 Days (48 hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days | Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours) | Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 2 Days (48 hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours) | Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 3 Days (72hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days | Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours) | The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 2 Days (48 hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours) | The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 3 Days (72hours) | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days | The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief. | The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS). | Posted | | Mean | Standard Deviation | Scores on a scale | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
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| Secondary | Subject Satisfaction With Treatment | Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied | Intent-to-Treat Population | Posted | | Number | | percentage of participants | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Patient Global Impression of Change (PGIC) at End of Study | Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. | Intent-to-Treat Population | Posted | | Number | | percentage of participants | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Clinician Global Impression of Change (CGIC) at End of Study | Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. | Intent-to-Treat Population | Posted | | Number | | percentage of participants | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel | Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study. | Intent-to-Treat Population | Posted | | Number | | Number of calls | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
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| Secondary | Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals | Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study. | Intent-to-Treat Population | Posted | | Number | | Number of participants | | 7 Days | | | | ID | Title | Description |
|---|
| OG000 | Tapentadol IR | Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days | | OG001 | Oxycodone IR | Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days |
| |
| Secondary | Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
|
| Secondary | Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) | Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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| Secondary | Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) | Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7). | Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7). | Posted | | Number | | participants | | Baseline and 7 Days | | | | ID | Title | Description |
|---|
| OG000 | End of Study: Not at All | Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study. | | OG001 | End of Study: 1-2 Days | Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study. | | OG002 | End of Study: 3-5 Days | Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study. | | OG003 | End of Study: 6-7 Days | Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study. |
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