TriangleNCT00932698 · OUTCOME
Number of Participants With One or More 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 first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
What was measured
An AE is 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. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
Analysis population: Safety population included all participants who received at least 1 dose of ixazomib.
Groups in this outcome
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 3 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 3 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 7 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 4 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 20 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 12 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 20 | Not reported | Not reported | Not reported | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 14 | Not reported | Not reported | Not reported | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 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
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 12
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 2
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 2
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 12
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 2
- units
- Participants
- description
- An AE is 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. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
- groups
- description
- Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
- id
- OG000
- title
- Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
- description
- Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
- id
- OG001
- title
- Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
- description
- Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
- id
- OG002
- title
- Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
- description
- Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
- id
- OG003
- title
- Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
- description
- Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
- id
- OG004
- title
- Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
- id
- OG005
- title
- Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
- id
- OG006
- title
- Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
- id
- OG007
- title
- Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
- id
- OG008
- title
- Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
- id
- OG009
- title
- Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
- id
- OG010
- title
- Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of ixazomib.
- reporting Status
- POSTED
- time Frame
- From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
- title
- Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice