Figures & data
Table 1. Baseline characteristics (n = 2331 in each group).
Table 2. Previous and concomitant analgesic medications (n = 2331 in each group).
PR: Prolonged release.
![Figure 2. Newly initiated treatment of adjuvant analgesics during the observation period.PR: Prolonged release.](/cms/asset/362e54d3-b31b-4e2e-a742-7afbb9cb8eb3/ipmt_a_12344475_f0002.jpg)
*p < 0.001 in favor of tapentadol PR.
BL: Baseline; mPDI: Modified pain disability index; PR: Prolonged release; SF: Short form; VAS: Visual analogue scale; W: Week.
![Figure 3. Change in main effectiveness parameters over the evaluation period.*p < 0.001 in favor of tapentadol PR.BL: Baseline; mPDI: Modified pain disability index; PR: Prolonged release; SF: Short form; VAS: Visual analogue scale; W: Week.](/cms/asset/f27c2520-c9f4-4541-9e3f-ccfbd74f61b5/ipmt_a_12344475_f0003.jpg)
Table 3. Mean changes in pain intensity over the evaluation period (n = 2331 in each group).
*p < 0.001 in favor of tapentadol PR.
mPDI: Modified pain disability index; PR: Prolonged release; VAS: Visual analogue scale; W: Week.
![Figure 4. Change in pain-related impairment of sleep over the observation period.*p < 0.001 in favor of tapentadol PR.mPDI: Modified pain disability index; PR: Prolonged release; VAS: Visual analogue scale; W: Week.](/cms/asset/5e1e3d8a-50e0-456b-974d-478782e1e4ae/ipmt_a_12344475_f0004.jpg)
(A) Mean PDQ7 score. (B) Pain components.
*p < 0.001 in favor of tapentadol PR.
BL: Baseline; PDQ: PainDETECT questionnaire; PR: Prolonged release; W: Week.
![Figure 5. Change in pain phenomenology over the observation period. (A) Mean PDQ7 score. (B) Pain components.*p < 0.001 in favor of tapentadol PR.BL: Baseline; PDQ: PainDETECT questionnaire; PR: Prolonged release; W: Week.](/cms/asset/c85b701c-c0b0-43b6-b9e0-af0f3d560d87/ipmt_a_12344475_f0005.jpg)
A BFI reference range of 0–28.8 indicates normal bowel function.
BFI: Bowel function index; BL: Baseline; PR: Prolonged release; VAS: Visual analogue scale; W: Week.
Reproduced with permission from the International Association for the Study of Pain [Citation40].
![Figure 6. Change in bowel function over the observation period.A BFI reference range of 0–28.8 indicates normal bowel function.BFI: Bowel function index; BL: Baseline; PR: Prolonged release; VAS: Visual analogue scale; W: Week.Reproduced with permission from the International Association for the Study of Pain [Citation40].](/cms/asset/603c1ecc-48fc-41f0-bc80-27a8c0d96ecd/ipmt_a_12344475_f0006.jpg)
Table 4. Drug-related adverse events during the 12-week observation period (n = 2331 in each group).
The primary end point included the three dimensions: tolerability, effectiveness and safety. A treatment responder had to fulfil the tolerability criterion and the safety criterion plus at least two criteria from the dimension effectiveness.
DRAE: Drug-related adverse event; PR: Prolonged release; QoL: Quality of life.
![Figure 7. Responder analysis.The primary end point included the three dimensions: tolerability, effectiveness and safety. A treatment responder had to fulfil the tolerability criterion and the safety criterion plus at least two criteria from the dimension effectiveness.DRAE: Drug-related adverse event; PR: Prolonged release; QoL: Quality of life.](/cms/asset/a6740085-a005-4955-bfa8-68f3cea4bac1/ipmt_a_12344475_f0007.jpg)