Study ID	Treatment	Any AEs	SAEs	Withdrawals
Imanaka 2013	Tapentadol ER (25 to 200 mg twice daily), n = 168 Oxycodone CR (5 to 40 mg twice daily), n = 172	Tapentadol 147/168 Oxycodone 155/172	Tapentadol 78/168 Oxycodone 69/172 Most SAEs due to disease progression (tapentadol 40, oxycodone 36) and judged unrelated to study medication	AE Tapentadol 12/168 Oxycodone 14/172 Deaths Tapentadol 3/168 Oxycodone 4/172 LoE Tapentadol 4/168 Oxycodone 1/172 Disease progression Tapentadol 10/168 Oxycodone 14/172 Other Tapentadol 29/168 Oxycodone 18/172
Imanaka 2014	Tapentadol ER titrated to maximum 500 mg daily, n = 50 Morphine SR titrated to maximum 140 mg daily, n = 50	Tapentadol 45/50 Morphine 47/50	Tapentadol 16/50 Morphine 16/50 Deaths Tapentadol 6/50 (disease progression 5, GI perforation 1) Oxycodone 4/50 (disease progression)	AE Tapentadol 5/50 Morphine 8/50 Disease progression Tapentadol 9/50 Morphine 11/50 LoE Tapentadol 3/50 Morphine 1/50 Other Tapentadol 5/50 Morphine 1/50
Kress 2014	Tapentadol PR 100 to 250 mg twice daily, n = 338 (titration) and n = 106 (maintenance) Morphine CR 40 to 100 mg twice daily, n = 158 (titration) and n = 109 (maintenance) Placebo n = 112 (maintenance)	During titration Tapentadol 169/338 Morphine 101/158 During maintenance Tapentadol 66/106 Morphine 68/109 Placebo 63/112	During titration Tapentadol 25/338 Morphine 6/158 Most common (7/338, 2/158) were neoplasms During maintenance Tapentadol 12/106 Morphine 6/109 Placebo 10/112 (Neoplasms 5/106, 1/109, 2/112)	During and after titration AE Tapentadol 29/338 Morphine 11/158 LoE Tapentadol 58/338 Morphine 17/158 Other Tapentadol 30/338 Morphine 18/158 Maintenance AE Tapentadol 5/106 Morphine 7/109 Placebo 5/112 LoE Tapentadol 2/106 Morphine 2/109 Placebo 4/112 Other Tapentadol 7/106 Morphine 8/109 Placebo 5/112
NCT00505414	Tapentadol PR 100 to 250 mg twice daily (titration and maintenance), n = 62 (titration) and n = 15 (maintenance) Morphine sulphate CR 45 to 90 mg twice daily (titration and maintenance), n = 31 (titration) and n = 18 (maintenance) Placebo, n = 14 (maintenance)	Over entire treatment period Tapentadol 39/62 Morphine 25/31 Placebo 6/14	Tapentadol 13/62 Morphine 8/31 Placebo 4/14 Deaths During titration Tapentadol 2/62 Morphine 0/31 During maintenance Tapentadol 0/15 Morphine 2/18 Placebo 1/14	Titration AE Tapentadol 8/62 Morphine 3/31 LoE Tapentadol 10/62 Morphine 1/31 Other Tapentadol 10/62 Morphine 8/31 Maintenance AE Tapentadol 2/15 Morphine 3/18 Placebo 2/14 LoE Tapentadol 1/15 Morphine 2/18 Placebo 1/14 Other Tapentadol 2/15 Morphine 0/18 Placebo 3/14
AE: adverse event; CR: controlled release; ER: extended release; GI: gastrointestinal; LoE: lack of efficacy; n: number of participants in treatment arm; PR: prolonged release; SAE: serious adverse event; SR: sustained release.