Post-marketing safety analyses for multiple marketed products in collaboration with the D:A:D study (206247)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42149
• EU PAS number:
  EUPAS18709
• Study ID:
  42149
• Official title and acronym:
  Post-marketing safety analyses for multiple marketed products in collaboration with the D:A:D study (206247)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belarus

  Belgium

  Croatia

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Israel

  Italy

  Latvia

  Lithuania

  Luxembourg

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Russian Federation

  Serbia

  Slovakia

  Spain

  Sweden

  Switzerland

  Ukraine

  United Kingdom

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 07/04/2017

Actual: 05/04/2017

Study start date

Planned: 28/04/2017

Actual: 27/04/2017

Data analysis start date

Planned: 28/04/2017

Actual: 27/04/2017

Date of final study report

Planned: 15/08/2017

Actual: 26/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-206247-protocol-redact

Regulatory

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