TriangleNCT01850524 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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
- From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)
What was measured
An AE was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
Analysis population: Safety population is defined as all participants who receive at least 1 dose of any study drug. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).
Groups in this outcome
Placebo + LenDex (Exposure Up to 18 Cycles)
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
Placebo + LenDex (Exposure ≥19 Cycles)
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Ixazomib + LenDex (Exposure ≥19 Cycles)
Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
| Group | Source count |
|---|---|
| Placebo + LenDex (Exposure Up to 18 Cycles) | 160 |
| Ixazomib+ LenDex (Exposure Up to 18 Cycles) | 163 |
| Placebo + LenDex (Exposure ≥19 Cycles) | 189 |
| Ixazomib + LenDex (Exposure ≥19 Cycles) | 191 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + LenDex (Exposure Up to 18 Cycles) | 160 | Not reported | Not reported | Not reported | Not reported |
| Ixazomib+ LenDex (Exposure Up to 18 Cycles) | 163 | Not reported | Not reported | Not reported | Not reported |
| Placebo + LenDex (Exposure ≥19 Cycles) | 189 | Not reported | Not reported | Not reported | Not reported |
| Ixazomib + LenDex (Exposure ≥19 Cycles) | 191 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + LenDex (Exposure Up to 18 Cycles) | 105 | Not reported | Not reported | Not reported | Not reported |
| Ixazomib+ LenDex (Exposure Up to 18 Cycles) | 119 | Not reported | Not reported | Not reported | Not reported |
| Placebo + LenDex (Exposure ≥19 Cycles) | 119 | Not reported | Not reported | Not reported | Not reported |
| Ixazomib + LenDex (Exposure ≥19 Cycles) | 125 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 163
- group Id
- OG002
- value
- 189
- group Id
- OG003
- value
- 191
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 119
- group Id
- OG002
- value
- 119
- group Id
- OG003
- value
- 125
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 163
- group Id
- OG002
- value
- 189
- group Id
- OG003
- value
- 191
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
- groups
- description
- Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
- id
- OG000
- title
- Placebo + LenDex (Exposure Up to 18 Cycles)
- description
- Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
- id
- OG001
- title
- Ixazomib+ LenDex (Exposure Up to 18 Cycles)
- description
- Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
- id
- OG002
- title
- Placebo + LenDex (Exposure ≥19 Cycles)
- description
- Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
- id
- OG003
- title
- Ixazomib + LenDex (Exposure ≥19 Cycles)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population is defined as all participants who receive at least 1 dose of any study drug. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).
- reporting Status
- POSTED
- time Frame
- From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice