GARDENIA: A Multi-country Observational Serial Chart Review Study of KANJINTI use in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49134
• EU PAS number:
  EUPAS30108
• Study ID:
  49134
• Official title and acronym:
  GARDENIA: A Multi-country Observational Serial Chart Review Study of KANJINTI use in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Greece

  Italy

  Netherlands

  Poland

  Romania

  Spain
• Study description:
  This study will describe patient characteristics and the utilization of KANJINTI in routine clinical practice
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 68 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/03/2019

Actual: 05/03/2019

Study start date

Planned: 09/12/2019

Actual: 28/10/2019

Data analysis start date

Planned: 13/10/2021

Actual: 10/12/2021

Date of final study report

Planned: 12/10/2022

Actual: 29/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20180020_01.02.06 Public Redacted Protocol Ver 1.0 2019-04-16 English

Regulatory

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