Peripheral Arterial Occlusive Disease
Conditions
Brief summary
The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group, * Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Deaths | From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake | Including all causes of deaths |
| Incidence of safety events of interest | From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake | Safety events of interest when gene therapy is used i.e. development of any new/recurrent cancer, immunogenicity reactions |
Countries
Belgium, France, Germany, Italy, Switzerland, United Kingdom, United States
Outcome results
None listed