TriangleNCT03301857 · OUTCOME
Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Count of Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 5 years
What was measured
EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.
Analysis population: FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
Groups in this outcome
Exposed to IP
Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
Not Exposed to IP
Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
| Group | Source count |
|---|---|
| Exposed to IP | 51 |
| Not Exposed to IP | 34 |
Reported measurements
Adjudicated positive ONJ
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 3 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
Malignancy, including malignancy in GCTB
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 6 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 1 | Not reported | Not reported | Not reported | Not reported |
Adjudicated positive AFF
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 2 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
Hypocalcemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 3 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
Hypocalcemia after treatment end
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
Pregnancy and lactation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
| Not Exposed to IP | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Adjudicated positive ONJ
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- title
- Malignancy, including malignancy in GCTB
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Adjudicated positive AFF
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Hypocalcemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Hypocalcemia after treatment end
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Pregnancy and lactation
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.
- groups
- description
- Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
- id
- OG000
- title
- Exposed to IP
- description
- Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
- id
- OG001
- title
- Not Exposed to IP
- param Type
- NUMBER
- population Description
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
- reporting Status
- POSTED
- time Frame
- Up to approximately 5 years
- title
- Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
- type
- PRIMARY
- unit Of Measure
- Count of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice