Risk of tendon rupture with systemic fluoroquinolone exposure: nested case-control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29762
• EU PAS number:
  EUPAS20892
• Study ID:
  29762
• Official title and acronym:
  Risk of tendon rupture with systemic fluoroquinolone exposure: nested case-control study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Nested case control study to quantify the risk of tendon rupture with systemic fluoroquinolone exposure in primary care.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Contact details

Daniel Morales

Study contact

[e-mail]

Daniel Morales

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 03/04/2017

Actual: 03/04/2017

Data collection

Planned: 10/04/2017

Actual: 10/04/2017

Start date of data analysis

Planned: 17/04/2017

Actual: 17/04/2017

Date of final study report

Planned: 29/01/2018

Actual: 01/11/2018

Sources of funding

EMA

Study protocol

Initial protocol

EUPAS20892.protocol

Regulatory

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