TriangleNCT00111813 · OUTCOME
Clinical AE Summary
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
What was measured
An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
Groups in this outcome
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
| Group | Source count |
|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 3 |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 3 |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 10 |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 6 |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 6 |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 6 |
Reported measurements
With one or more AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
With no AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
With drug-related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
With Serious AEs (SAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
With drug-related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Who died
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Who discontinued due to AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
Who discontinued due to drug-related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Who discontinued due to SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Who discontinued due to drug-related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat 200 mg + Bortezomib 0.7 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 200 mg + Bortezomib 0.9 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 300 mg + Bortezomib 1.3 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 0.9 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.1 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vorinostat 400 mg + Bortezomib 1.3 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- title
- With one or more AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- With no AEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- title
- With drug-related AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- title
- With Serious AEs (SAEs)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- title
- With drug-related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Who died
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- title
- Who discontinued due to AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- title
- Who discontinued due to drug-related AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Who discontinued due to SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Who discontinued due to drug-related SAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
- groups
- description
- Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
- id
- OG000
- title
- Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
- description
- Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
- id
- OG001
- title
- Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
- description
- Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
- id
- OG002
- title
- Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
- description
- Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
- id
- OG003
- title
- Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
- description
- Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
- id
- OG004
- title
- Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
- description
- Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
- id
- OG005
- title
- Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
- title
- Clinical AE Summary
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice