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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003431-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGG492 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI, CT or ultrasound was permitted if MRI was contraindicated | Procedure | MRI/CT/ultrasound of abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adrenal Cortical Adenomas | 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) | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 |
| Incidence of Uterine Endometrial Stromal Sarcomas | Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females) | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 |
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Inclusion Criteria:
Exclusion Criteria:
- There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tallahassee | Florida | 32308 | United States | ||
| Novartis Investigative Site |
The first period focused on contacting the patients, obtaining consent for follow-up, and conducting screening assessments. The second period of the study focused on performing the follow-up procedures, obtaining and interpreting the results, and referring the patient, if necessary, to an appropriate medical specialist.
The purpose of this follow-up safety study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in Study BGG492A2207 and/or BGG492A2212.
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| ID | Title | Description |
|---|---|---|
| FG000 | BGG492 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexamethasone Supression Test | Procedure | Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol |
|
| Sonogram | Procedure | Sonogram of the uterus (females only) |
|
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| Biopsy | Procedure | Uterine endometrial biopsy (females only) |
|
|
| BGG492 | Drug | No study-drug was administered in this study |
|
|
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Novartis Investigative Site | Hoffman | New Jersey | 08831 | United States |
| Novartis Investigative Site | Dallas | Texas | 75230 | United States |
| Novartis Investigative Site | Bernau | 16321 | Germany |
| Novartis Investigative Site | Bielefeld | 33617 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Kehl-Kork | 77694 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Budapest | H-1097 | Hungary |
| Novartis Investigative Site | Kecskemét | 6000 | Hungary |
| Novartis Investigative Site | Szombathely | 9700 | Hungary |
| Novartis Investigative Site | Florence | FI | 50143 | Italy |
| Novartis Investigative Site | Milan | MI | 20142 | Italy |
| Novartis Investigative Site | Hlohovec | Slovak Republic | 92001 | Slovakia |
| Novartis Investigative Site | Košice | Slovak Republic | 041 90 | Slovakia |
| Novartis Investigative Site | Banská Bystrica | Slovakia | 97517 | Slovakia |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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Includes all patients who signed the informed consent form for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | BGG492 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adrenal Cortical Adenomas | 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) | Full analysis Set: included all patients who signed informed consent to enter the study | Posted | Number | Particpants | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 |
|
|
| ||||||||||||||||||||||||||
| Primary | Incidence of Uterine Endometrial Stromal Sarcomas | Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females) | 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) | Posted | Number | Participants | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BGG492 | 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 | 5 | 59 | 3 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Cyst | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D018246 | Adrenocortical Adenoma |
| D018203 | Sarcoma, Endometrial Stromal |
| ID | Term |
|---|---|
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D036821 | Endometrial Stromal Tumors |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D000097873 | Postmortem Imaging |
| D019220 | High-Energy Shock Waves |
| D001706 | Biopsy |
| C000591013 | selurampanel |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001344 | Autopsy |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003952 | Diagnostic Imaging |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
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