Johnson & Johnson (J&J)

This sponsor has funded 11 studies across 30 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
16778 Finalised Not included in RMP Misuse and Abuse of Loperamide in the United States Yes Yes
23109 Finalised Not included in RMP Safety Profile of Extended Release (650 mg) Acetaminophen Products in the United States: Non-Interventional Post-authorization Safety Study of the... Yes Yes
31269 Ongoing Not included in RMP Risk Factors for Aseptic Loosening after Primary Total Knee Arthroplasty with Cemented Knee Implants (Aseptic Loosening - Total Knee Arthroplasty) Yes No
31333 Ongoing Not included in RMP Incidence and risk of heart failure in patients following metal-on-metal (MoM) hip arthroplasty Yes No
34300 Finalised Not included in RMP Incidence and risk of Nail Breakage in patients implanted with the DePuy Synthes TFN-ADVANCED™ Proximal Femoral Nailing System (TFNA) Yes No
34490 Planned Not included in RMP COVID-19: Risk Factors Associated with Respiratory Support Needs in Patients with Viral Disease (COVID-19: US Ventilator Use) No No
34494 Planned Not included in RMP COVID-19: Viral Pneumonia – Understanding Disease Presentation, Risk Factors and Healthcare Utilization, Including Ventilator and Extracorporeal... No No
37360 Finalised Not included in RMP International Registry of Coronavirus Exposure in Pregnancy (IRCEP) Yes No
48616 Ongoing Not included in RMP Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance) (BETTER) Yes No
50081 Planned Not included in RMP An exploratory pilot study to assess the feasibility of linking real world over-the-counter (OTC) analgesics use through consumer survey data to... No No
50570 Finalised Not included in RMP Comparative safety study to assess the risk of anastomotic leakage of two-row versus three-row manual circular staplers in colorectal anastomosis Yes Yes

PAS by Risk Management Plan (RMP) requirement

Johnson & Johnson (J&J)

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.