TriangleNCT02939183 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Oprozomib in Combination With Dexamethasone and/or Pomalidomide)
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 of cycle 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 in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. 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. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment and clinical laboratory tests were recorded as TEAEs.
Analysis population: Participants in the safety analysis set who received any amount of oprozomib, pomalidomide and/or dexamethasone in Parts 1 and 2.
Groups in this outcome
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 5 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 8 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 8 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 8 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
Any Treatment-related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 8
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 8
- title
- Any Treatment-related TEAE
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 8
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. 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. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment and clinical laboratory tests were recorded as TEAEs.
- groups
- description
- In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG000
- title
- Oprozomib IR 150 mg/Day + Dexamethsone
- description
- In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG001
- title
- Oprozomib GR 150 mg/Day + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG002
- title
- Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG003
- title
- Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG004
- title
- Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG005
- title
- Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG006
- title
- Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG007
- title
- Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants in the safety analysis set who received any amount of oprozomib, pomalidomide and/or dexamethasone in Parts 1 and 2.
- reporting Status
- POSTED
- time Frame
- Day 1 of cycle 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 in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Oprozomib in Combination With Dexamethasone and/or Pomalidomide)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice