A Global Imatinib and Nilotinib Pregnancy Exposure Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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All Indications for Glivec/Gleevec and Tasigna

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1 - Pregnancy/Fetal Exposure

Tasigna

Intervention Type DRUG

Gleevec

Intervention Type DRUG

Cohort 2 - Interrupted TKI

No interventions assigned to this group

Interventions

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Tasigna

Intervention Type DRUG

Gleevec

Intervention Type DRUG

Eligibility Criteria

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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