All Indications for Glivec/Gleevec and Tasigna
Conditions
Keywords
Female, Pregnancy, Hematologic Pregnancy, Complications, Registry, Pregnant Registry, CML, GIST, Gleevec, Tasigna, Glivec, Pregnancy Exposure
Brief summary
This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure. * Be at least 18 years of age * Reside in a country supported by the Registry
Exclusion criteria
* Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects | During pregnancy or within 6 months prior to conception |
Secondary
| Measure | Time frame |
|---|---|
| Assess impact on maternal CML disease when treatment is interrupted | During pregnancy or within 6 months prior to conception |
| Assess post 12 month post-delivery data on maternal and infant status | 12 months after birth |
Countries
United States
Outcome results
None listed