TriangleNCT01217957 · OUTCOME
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
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
- Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)
What was measured
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Analysis population: The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.
Groups in this outcome
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone | 3 |
| Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone | 3 |
| Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone | 6 |
| Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone | 3 |
Reported measurements
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone | 2 | 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
- 6
- group Id
- OG003
- value
- 3
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- SAE
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- units
- Participants
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
- groups
- description
- In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
- description
- In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
- description
- In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
- description
- In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG003
- title
- Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.
- reporting Status
- POSTED
- time Frame
- Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)
- title
- Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice