Study identification

PURI

https://redirect.ema.europa.eu/resource/45853

EU PAS number

EUPAS45747

Study ID

45853

Official title and acronym

Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Germany (Lena-PIE Germany)

DARWIN EU® study

No

Study countries

Germany

Study description

Evaluation of the outcome indicator (safety outcome): (i) Immediate follow-up and root-cause analysis of all pregnancy cases in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln in Germany reported to STADA. (ii) Systematic database review in STADA’s safety database to ensure that no pregnancy case in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln in Germany was missed. Follow-up and root-cause analysis of missed cases. (iii) Systematic review of EudraVigilance data to identify pregnancy cases in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln in Germany not known to STADA. Data entry and processing in STADA’s safety database, follow-up and root-cause analysis of cases not known.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Markus Torben Schweimer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

STADA Arzneimittel AG
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)