following multiple oral dosing. The study will assess single-dose PK as well as multiple dose PK, safety and tolerability for up to 6 months. Study D2288R00081 All identified and To describe First annual potential risks demographic, report delivered Post-market and missing clinical, and end of 4Q2016 observational drug information. treatment and every year utilisation study characteristics in thereafter until the baseline of completion. patients treated with naloxegol. To describe treatment pattern characteristics of naloxegol utilisation at initiation and follow-up. Study D2288R00082 All identified and To estimate First annual potential and rates for report delivered Post-market missing end of 4Q2016 observational safety information. and every year study in patients taking Health outcomes of thereafter until opioids for cancer pain interest completion. naloxegol treated patients with active cancer pain. Identified and To estimate event annual Study D2288R00084 potential risks rates for report delivered Post-market and missing by the end of observational safety information 4Q2016 and every in patients taking opioids Health outcomes of year thereafter for non-cancer pain. interest until completion. naloxegol treated patients with pain. Cardiovascular Study Cardiovascular This observational Final report risk (missing study will estimated A US post-marketing, information: characterize the CV December 2023. comparative, efficacy/safety in risk and major Annual reports observational study to high risk adverse event starting in 2016 evaluate the cardiovascular cardiac events such until study cardiovascular safety of patients) as myocardial completion. naloxegol in patients infarction, with non-cancer pain in cerebrovascular comparison to other accident and cardiac treatments for death. constipation.
following multiple oral dosing. The study will assess single-dose PK as well as multiple dose PK, safety and tolerability for up to 6 months. Study D2288R00081 Post-market observational drug utilisation study All identified and potential risks and missing information. To describe demographic, clinical, and treatment characteristics in the baseline of patients treated with naloxegol. To describe treatment pattern characteristics of naloxegol utilisation at initiation and follow-up. First annual report delivered end of 4Q2016 and every year thereafter until completion. Study D2288R00082 Post-market observational safety study in patients taking opioids for cancer pain All identified and potential and missing information. To estimate rates for Health outcomes of interest naloxegol treated patients with active cancer pain. First annual report delivered end of 4Q2016 and every year thereafter until completion. Study D2288R00084 Post-market observational safety in patients taking opioids for non-cancer pain. Identified and potential risks and missing information To estimate event rates for Health outcomes of interest naloxegol treated patients with pain. annual report delivered by the end of 4Q2016 and every year thereafter until completion. Cardiovascular Study A US post-marketing, comparative, observational study to evaluate the cardiovascular safety of naloxegol in patients with non-cancer pain in comparison to other treatments for constipation. Cardiovascular risk (missing information: efficacy/safety in high risk cardiovascular patients) This observational study will characterize the CV risk and major adverse event cardiac events such as myocardial infarction, cerebrovascular accident and cardiac death. Final report estimated December 2023. Annual reports starting in 2016 until study completion.
auspar-naloxegol-oxalate-160601_0.docx