TriangleNCT02939183 · OUTCOME
Number of Participants With TEAEs and Treatment-emergent Serious AEs (Open-label Roll-over)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 to 30 (+7) days after the last dose of study treatment or end of study date, whichever is earlier (where each cycle was 28 days). Median treatment duration for the open-label roll-over arm was 75.14 weeks
What was measured
TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Serious TEAEs were any AE meeting at least 1 of the following criteria: fatal; life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
Analysis population: The safety analysis set for roll-over participants included all roll-over participants who received any amount of oprozomib, pomalidomide and/or dexamethasone. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
Groups in this outcome
Open-label Roll-over
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
| Group | Source count |
|---|---|
| Open-label Roll-over | 7 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Open-label Roll-over | 7 | Not reported | Not reported | Not reported | Not reported |
Any Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Open-label Roll-over | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Any Serious TEAE
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Serious TEAEs were any AE meeting at least 1 of the following criteria: fatal; life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
- groups
- description
- Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
- id
- OG000
- title
- Open-label Roll-over
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set for roll-over participants included all roll-over participants who received any amount of oprozomib, pomalidomide and/or dexamethasone. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
- reporting Status
- POSTED
- time Frame
- Day 1 to 30 (+7) days after the last dose of study treatment or end of study date, whichever is earlier (where each cycle was 28 days). Median treatment duration for the open-label roll-over arm was 75.14 weeks
- title
- Number of Participants With TEAEs and Treatment-emergent Serious AEs (Open-label Roll-over)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice