Spots Global Cancer Trial Database for Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

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Trial Identification

Brief Title: Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

Official Title: A Multicenter Medical Safety Follow-up Study for Patients With Partial Onset Seizures Who Received More Than 28 Days of Total Exposure to BGG492 in Studies CBGG492A2207 and/or CBGG492A2212

Study ID: NCT02150213

Conditions

Adrenocortical Adenoma

Endometrial Stromal Sarcomas

Interventions

MRI, CT or ultrasound was permitted if MRI was contraindicated

Dexamethasone Supression Test

Sonogram

Biopsy

BGG492

Study Description

Brief Summary: To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Detailed Description: The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.