Risk of peripheral neuropathy with systemic fluoroquinolone exposure: population-based nested case-control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29759
• EU PAS number:
  EUPAS27627
• Study ID:
  29759
• Official title and acronym:
  Risk of peripheral neuropathy with systemic fluoroquinolone exposure: population-based nested case-control study
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Nested case-control study examining the risk of incidence peripheral neuropathy with systemic fluoroquinolone exposure in primary care using co-amoxiclav exposure as a negative control.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 04/09/2017

Actual: 04/09/2017

Study start date

Planned: 06/11/2017

Actual: 06/11/2017

Data analysis start date

Planned: 08/01/2018

Actual: 08/01/2018

Date of final study report

Planned: 03/09/2018

Actual: 15/05/2019

Sources of funding

EMA

Study protocol

Initial protocol

EUPASneuropathy.protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable