Janssen R&D

This sponsor has funded 17 studies across 40 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
3590 Finalised Post-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of... Yes No
16023 Finalised A Multi-Country Prospective Multi-Drug Resistant Tuberculosis Patient Registry to Monitor Bedaquiline Safety, Utilization, and Emergence of Resistance Yes No
20065 Finalised Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A... No No
20197 Finalised RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden No No
20730 Finalised RRA-17401, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Taiwan No No
20733 Finalised RRA-12037, Risperidone breast cancer study - Sweden No No
20969 Finalised RRA-12037, Risperidone breast cancer study - Taiwan No No
23531 Finalised RRA-21430: Acute Pancreatitis in Patients with Type 2 Diabetes Who are New Users of Canagliflozin as Compared with New Users of Other... No Yes
23705 Finalised Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A... No Yes
27376 Finalised Additional Pharmacovigilance Study to Evaluate the Risks of Major Hemorrhage With the Administration of IMBRUVICA® (ibrutinib) No No
27670 Finalised Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Below Knee Lower Extremity Amputation for Patients with Type 2... No Yes
30740 Ongoing A Retrospective Cohort Study Using Health Administrative Claims Databases to Assess Adverse Pregnancy and Infant Outcomes in Women with Psoriasis Who... No No
36038 Finalised Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine (Tramadol vs Codeine) Yes No
47585 Planned PCSCVM003617/ A Real-World Database Study of Canagliflozin Utilization in Type 1 Diabetes Patients Over Time among European Countries No No
49218 Ongoing A Post-authorization Safety Study to Evaluate the Safety of Multiple Myeloma Patients Treated with Ciltacabtagene Autoleucel No No
49827 Planned A Post-authorization Safety Study to Evaluate the Incidence of and Risk Factors for Severe and Fatal Infusion-related Reactions in Participants... No No
50031 Ongoing Post-authorization Safety Study: Ponesimod Pregnancy Outcomes Program Utilizing Enhanced Pharmacovigilance Monitoring (POEM) No No

PAS by Risk Management Plan (RMP) requirement

Janssen R&D

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.