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Table 5 Post-marketing studies ongoing at three year follow-up after advertising (Dec 2018)

From: Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs

Drug Study ID Requested Clinical question
Advertised drugs
 Aripiprazole IM EUPAS21056 EMA Specific harms (extrapyramidal symptoms)
 Canagliflozin EUPAS27670 EMA Specific harm (lower limb amputations)
 Canagliflozin NDA 204042 commitment no. 1 FDA Specific harm (ketoacidosis)
 Canagliflozin NDA 204042 commitment no. 3 FDA Specific harm (various conditions)
 Fluticasone propionate / formoterol EUPAS3702a MHRA Benefits and harms
 Lisdexamfetamin EUPAS20546 EMA Specific harm (cardiovascular events)
 Rivaroxaban EUPAS11299, EUPAS9895, EUPAS11141, and EUPAS11145 EMA Specific harms (bleeding events and liver disease)
 Tiotropium / olodaterol EUPAS14273 Japan Long-term benefits and harms
 Tiotropium / olodaterol EUPAS21574 EMA Specific harms (cardiovascular)
 Tiotropium / olodaterol EUPAS14956 South Korea Benefits and harms
 Umeclidinium/ vilanterol EUPAS9868 Japan Benefits and harms
 Umeclidinium/ vilanterol EUPAS11397 South Korea Benefits and harms
 Vortioxetine NDA 204447 commitment no. 6 FDA Benefits and harms
 Vortioxetine EUPAS19199 EMA Clinical use and several specific harms
Comparator drugs
 Duloxetine EUPAS20253b United States Specific harms (maternal and fetal harms)
 Duloxetine NDA 21427 commitment no. 2 FDA Specific harms (maternal and fetal harms)
 Methylphenidate EUPAS4551c EMA Harms
 Methylphenidate EUPAS3985c EMA Long-term harms
 Umeclidinium EUPAS14947 South Korea Benefits and harms
 Umeclidinium EUPAS10224 Japan Benefits and hams
Advertised drugs and comparator drugs
 Aclidinium and aclidinium/ formoterol EUPAS6559 EMA Clinical use
 Aclidinium and aclidinium/ formoterol EUPAS13616 EMA Specific harms (cardiovascular and mortality)
 Dabigatran and rivaroxaban, versus warfarin EUPAS13017 France Benefits and harms
 Olodaterol and olodaterol/tiotropium EUPAS21574 EMA Specific harms (cardiovascular events)
 Umeclidinium and umeclidinium/ vilanterol EUPAS10316 EMA Specific harms (cardiovascular and cerebrovascular events)
  1. EMA European Medicines Agency; FDA US Food and Drug Administration; IM Intramuscular. aThe study was scheduled to report data in 2015, but data had not been submitted. bThis study may likely be the same. cThe two methylphenidate studies were planned to finish in 2014 and 2015, but they were listed as ongoing since data had not been reported on the website