A Global Imatinib and Nilotinib Pregnancy Exposure Registry
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/13/2015 |
| Start Date: | January 2011 |
| End Date: | October 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)
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.
and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six
months prior to pregnancy.
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/exclusion criteria may apply
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