Phase 2
N=59
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Adrenocortical Adenoma · Endometrial Stromal Sarcomas
Bottom Line
View on ClinicalTrials.gov: NCT02150213 ↗Enrolled (actual)
59
Serious AEs
8.5%
Results posted
Jul 2016
Primary outcome: Primary: Incidence of Adrenal Cortical Adenomas — 3 Particpants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MRI, CT or ultrasound was permitted if MRI was contraindicated (Procedure); Dexamethasone Supression Test (Procedure); Sonogram (Procedure); Biopsy (Procedure); BGG492 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adrenal Cortical Adenomas |
3 | — |
| PRIMARY Incidence of Uterine Endometrial Stromal Sarcomas |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- Written informed consent had to be obtained before any assessment was performed;
- Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
- Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
- At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.
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
Data sourced from ClinicalTrials.gov (NCT02150213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.