TriangleNCT02150213 · STUDY IN CONTEXT
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- trial label
- Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- outcome key
- om-0000
- source section id
- NCT02150213-om-0000
- source outcome index
- 0
- endpoint
- Incidence of Adrenal Cortical Adenomas
- endpoint definition
- 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)
- time origin
- Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis Set: included all patients who signed informed consent to enter the study
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- outcome key
- om-0001
- source section id
- NCT02150213-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Uterine Endometrial Stromal Sarcomas
- endpoint definition
- Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
- time origin
- Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- outcome key
- om-0000
- arm key
- OG000
- arm label
- BGG492
- regimen
- 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
- analyzed count
- 59
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02150213-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- outcome key
- om-0001
- arm key
- OG000
- arm label
- BGG492
- regimen
- 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
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02150213-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenal-cortical-adenoma
- nct id
- NCT02150213
- harm key
- EG000
- source section id
- NCT02150213-ae
- event group key
- EG000
- event group label
- BGG492
- serious affected
- 5
- serious at risk
- 59
- other affected
- 3
- other at risk
- 59
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice