Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Sarcoma

Adenoma

Seizures

Sarcoma, Endometrial Stromal

Adrenocortical Adenoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Endometrial Stromal Tumors

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Soft Tissue Sarcoma

Endometrial Stromal Sarcoma

Adenoma of the Adrenal Gland

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day

MRI, CT or ultrasound was permitted if MRI was contraindicated

Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol

Dexamethasone Supression Test

Sonogram

Uterine endometrial biopsy (females only)

Biopsy

No study-drug was administered in this study

BGG492

Novartis Pharmaceuticals

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).

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.

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

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

Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)

Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)

Age, Continuous

Gender

Includes all patients who signed the informed consent form for the study.

Study Director

Full analysis Set: included all patients who signed informed consent to enter the study

Incidence of Adrenal Cortical Adenomas

Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)

Incidence of Uterine Endometrial Stromal Sarcomas

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492	NCT02150213	Adrenocortical ... Endometrial Str...	MRI, CT or ultr... Dexamethasone S... Sonogram Biopsy BGG492	18 Years -	Novartis
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492	NCT02150213	Adrenocortical ... Endometrial Str...	MRI, CT or ultr... Dexamethasone S... Sonogram Biopsy BGG492	18 Years -	Novartis

Spots Global Cancer Trial Database for mri, ct or ultrasound was permitted if mri was contraindicated