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This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IXAZOMIB | Experimental | Part A: Participants will receive a single dose of 4.1-milligram (mg) [14C]-IXAZOMIB oral solution containing approximately 500-nCurie (nCi) of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, participants may be administered a single 4.0-mg capsule of IXAZOMIB. Participants will return to the clinic in the evening before Days 14, 21, 28, and 35 for a 24-hour overnight clinic visit. Part B: Eligible participants from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Participants may receive IXAZOMIB capsules administered orally at a dose of 4.0-mg once weekly on Days 1, 8, and 15 of 28-day cycles. Participants will continue in this study until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IXAZOMIB | Drug | Part A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21. Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose |
| Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib | Time to reach the maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose |
| Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib | AUC(0-312) is a measure of the area under the plasma concentration time-curve from time zero to 312 hrs post-dose for ixazomib. | Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose |
| Part A: Cmax: Maximum Observed Plasma Concentration of TRA | Maximum observed plasma concentration (Cmax) of TRA is the peak plasma concentration of TRA, obtained directly from the plasma TRA concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Part A: Tmax: Time to Reach the Cmax for TRA | Time to reach the maximum observed plasma concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the plasma TRA concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma | The plasma samples were pooled for participants over 816 hrs post-dose, and data was analysed using the Hamilton method time-proportional pooling, and therefore the data is reported as "percent of total radioactivity in plasma" with measure type as "number" and measure dispersion as "Not applicable, NA". | Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose |
Not provided
Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland | Ohio | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28932928 | Derived | Gupta N, Zhang S, Pusalkar S, Plesescu M, Chowdhury S, Hanley MJ, Wang B, Xia C, Zhang X, Venkatakrishnan K, Shepard DR. A phase I study to assess the mass balance, excretion, and pharmacokinetics of [14C]-ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2018 Jun;36(3):407-415. doi: 10.1007/s10637-017-0509-1. Epub 2017 Sep 21. |
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Participants with a historical diagnosis of advanced solid tumors or lymphoma were enrolled in 1 treatment group of this 2-part study to receive ixazomib.
Participants took part in the study at 1 investigative site in the United States from 19 March 2014 to 09 February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixazomib | Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all participants who received at least 1 dose of ixazomib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixazomib | Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve. | Pharmacokinetic(PK)-evaluable population included all participants who received protocol-specified single[14C]-ixazomib dose(Part A), did not receive any excluded concomitant medications till completion(Part A), had sufficient concentration-time and total radioactivity(TRA)-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Cycle 5 Day 45).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixazomib | Ixazomib 4.1 milligram (mg) containing approximately 500-nCurie (nCi) of total radioactivity [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21 in Part A. Participants who had completed their Day 35 assessments in Part A were eligible to continue in Part B. Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity in Part B. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C548400 | ixazomib |
Not provided
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|
| Part A: AUC(0-816): Area Under the Plasma Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA |
AUC(0-816) is a measure of the area under the plasma concentration time-curve from time zero to 816 hrs post-dose for TRA. |
| Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose |
| Part A: Cmax: Maximum Observed Whole Blood Concentration of TRA | Maximum observed whole blood concentration (Cmax) of a TRA is the peak whole blood concentration of TRA, obtained directly from the whole blood TRA concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Part A: Tmax: Time to Reach the Maximum Observed Whole Blood Concentration (Cmax) for TRA | Time to reach the maximum observed whole blood concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the whole blood TRA concentration-time curve. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Part A: AUC(0-816): Area Under the Whole Blood Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA | AUC(0-816) is a measure of the area under the whole blood concentration time-curve from time zero to 816 hrs post-dose for TRA. | Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose |
| Part A: Cumulative Percentage of Ixazomib Dose Recovered in the Urine | Percentage of the ixazomib dose excreted unchanged in the urine from 0 to 168 hrs post-dose. | Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose |
| Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Feces | Percentage of the TRA dose excreted in feces from Day 1 to Day 35 of Part A | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Urine | Percentage of the TRA dose excreted in urine from Day 1 to Day 35 of Part A. | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
| Part A: Renal Clearance of Ixazomib | Renal clearance is the volume of plasma from which ixazomib is completely removed by the kidney in a given amount of time, calculated as the amount of ixazomib excreted in the urine divided by the area under the plasma ixazomib concentration-time curve. | Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose |
| Ixazomib and Metabolites as Percent of Total Dose Administered in Urine | The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled urine. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA". | Day 1 pre-dose and at multiple time points (up to Day 35) post-dose |
| Ixazomib and Metabolites as Percent of Total Dose Administered in Feces | The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled feces. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA". | Day 1 pre-dose and at multiple time points (up to Day 35) post-dose |
| Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to Cycle 5 Day 45 |
| Number of Participants With TEAEs Related to Investigations System Organ Class for Laboratory Values | Baseline up to Cycle 5 Day 45 |
| Number of Participants With TEAEs Related to Vital Signs | Vital signs included oral body temperature, heart rate, and blood pressure. | Baseline up to Cycle 5 Day 25 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
|
|
| Primary | Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib | Time to reach the maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Median | Full Range | hour (hr) | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose |
|
|
|
| Primary | Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib | AUC(0-312) is a measure of the area under the plasma concentration time-curve from time zero to 312 hrs post-dose for ixazomib. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose |
|
|
|
| Primary | Part A: Cmax: Maximum Observed Plasma Concentration of TRA | Maximum observed plasma concentration (Cmax) of TRA is the peak plasma concentration of TRA, obtained directly from the plasma TRA concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram-equivalent per milliliter | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: Tmax: Time to Reach the Cmax for TRA | Time to reach the maximum observed plasma concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the plasma TRA concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Median | Full Range | hr | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: AUC(0-816): Area Under the Plasma Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA | AUC(0-816) is a measure of the area under the plasma concentration time-curve from time zero to 816 hrs post-dose for TRA. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram-equivalent*hour per milliliter | Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose |
|
|
|
| Primary | Part A: Cmax: Maximum Observed Whole Blood Concentration of TRA | Maximum observed whole blood concentration (Cmax) of a TRA is the peak whole blood concentration of TRA, obtained directly from the whole blood TRA concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram-equivalent per milliliter | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: Tmax: Time to Reach the Maximum Observed Whole Blood Concentration (Cmax) for TRA | Time to reach the maximum observed whole blood concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the whole blood TRA concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Median | Full Range | hr | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: AUC(0-816): Area Under the Whole Blood Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA | AUC(0-816) is a measure of the area under the whole blood concentration time-curve from time zero to 816 hrs post-dose for TRA. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | nanogram-equivalent* hour per milliliter | Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose |
|
|
|
| Primary | Part A: Cumulative Percentage of Ixazomib Dose Recovered in the Urine | Percentage of the ixazomib dose excreted unchanged in the urine from 0 to 168 hrs post-dose. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Mean | Standard Deviation | percentage of dose | Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose |
|
|
|
| Primary | Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Feces | Percentage of the TRA dose excreted in feces from Day 1 to Day 35 of Part A | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Mean | Standard Deviation | percentage of dose | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Urine | Percentage of the TRA dose excreted in urine from Day 1 to Day 35 of Part A. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Mean | Standard Deviation | percentage of dose | Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose |
|
|
|
| Primary | Part A: Renal Clearance of Ixazomib | Renal clearance is the volume of plasma from which ixazomib is completely removed by the kidney in a given amount of time, calculated as the amount of ixazomib excreted in the urine divided by the area under the plasma ixazomib concentration-time curve. | The PK-evaluable population included all participants who received the protocol-specified single [14C]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Geometric Mean | Standard Deviation | liter per hour (L/hr) | Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose |
|
|
|
| Secondary | Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma | The plasma samples were pooled for participants over 816 hrs post-dose, and data was analysed using the Hamilton method time-proportional pooling, and therefore the data is reported as "percent of total radioactivity in plasma" with measure type as "number" and measure dispersion as "Not applicable, NA". | PK-evaluable population with acceptable excretion recovery included all participants who received protocol-specified single[14C]-ixazomib dose(Part A), did not receive any excluded concomitant medications till completion(Part A), and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Number | percent of total radioactivity in plasma | Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose |
|
|
|
| Secondary | Ixazomib and Metabolites as Percent of Total Dose Administered in Urine | The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled urine. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA". | PK-evaluable population with acceptable excretion recovery included all participants who received protocol-specified single[14C]-ixazomib dose(Part A), did not receive any excluded concomitant medications till completion(Part A), and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Number | percentage of dose | Day 1 pre-dose and at multiple time points (up to Day 35) post-dose |
|
|
|
| Secondary | Ixazomib and Metabolites as Percent of Total Dose Administered in Feces | The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled feces. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA". | PK-evaluable population with acceptable excretion recovery included all participants who received protocol-specified single[14C]-ixazomib dose(Part A), did not receive any excluded concomitant medications till completion(Part A), and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance. | Posted | Number | percentage of dose | Day 1 pre-dose and at multiple time points (up to Day 35) post-dose |
|
|
|
| Secondary | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | The safety population included all participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to Cycle 5 Day 45 |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Investigations System Organ Class for Laboratory Values | The safety population included all participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to Cycle 5 Day 45 |
|
|
|
| Secondary | Number of Participants With TEAEs Related to Vital Signs | Vital signs included oral body temperature, heart rate, and blood pressure. | The safety population included all participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to Cycle 5 Day 25 |
|
|
|
| 1 |
| 7 |
| 7 |
| 7 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| P6, ML00749506 |
|
| P7, ML00752034 |
|
| Title | Measurements |
|---|
|
| U3 |
|
| U4 |
|
| U5, ML00701258 |
|
| U6, ML00701201 |
|
| U7 |
|
| U8 |
|
| U10, ML00751996 |
|
| U11, ML00749506 |
|
| U12, ML00752034 |
|
| U13 |
|
| Title | Measurements |
|---|
|
| FH3, ML00701258 |
|
| FH4, ML00701201 |
|
| FH5 |
|
| FH7, ML00752034 |
|
| FH8 |
|
| FH9 |
|
| Title | Measurements |
|---|---|
|