Pharmacokinetics Study of Oral IXAZOMIB in Participants W... | NCT01454076 | Trialant
NCT01454076
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Nov 1, 2017Actual
Enrollment
112Actual
Phase
Phase 1
Conditions
Nonhematologic Malignancies
Lymphoma
Interventions
Ixazomib 2.5 mg
Ixazomib 4 mg Capsule A
Ixazomib 4 mg Capsule B
Ketoconazole
Rifampin
Clarithromycin
Ixazomib 4 mg Capsule B
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01454076
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C16009
Secondary IDs
ID
Type
Description
Link
U1111-1183-0218
Registry Identifier
WHO
Brief Title
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
Official Title
A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jun 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 10, 2011Actual
Primary Completion Date
Apr 1, 2015Actual
Completion Date
Jun 16, 2016Actual
First Submitted Date
Oct 13, 2011
First Submission Date that Met QC Criteria
Oct 17, 2011
First Posted Date
Oct 18, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2017
Results First Submitted that Met QC Criteria
Jun 16, 2017
Results First Posted Date
Nov 1, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 16, 2017
Last Update Posted Date
Nov 1, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Millennium Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.
Detailed Description
Not provided
Conditions Module
Conditions
Nonhematologic Malignancies
Lymphoma
Keywords
Cmax: maximum plasma concentration
AUC0-tlast: area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Experimental
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants will receive ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Drug: Ixazomib 2.5 mg
Drug: Ixazomib 4 mg Capsule B
Drug: Ketoconazole
Arm 2: Ixazomib 4 mg Capsule A or B
Experimental
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants will receive ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Drug: Ixazomib 4 mg Capsule A
Drug: Ixazomib 4 mg Capsule B
Arm 3: Ixazomib 4 mg Fasted or Fed
Experimental
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants will receive ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixazomib 2.5 mg
Drug
Ixazomib 2.5 mg Capsule B (Cycle 1 only)
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cmax: Maximum Observed Plasma Concentration for Ixazomib
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants 18 years or older.
Participants must have a diagnosis of histologically or cytologically confirmed metastatic and/or advanced solid tumor malignancy or lymphoma for which no effective standard treatment is available.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Female participants who are postmenopausal at least 1 year, or surgically sterile, or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time from the time of signing the consent form through 90 days after the last dose of study drug, or agree to practice true abstinence.
Male participants, even if surgically sterilized, agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug or agree to practice true abstinence.
Voluntary written informed consent.
Clinical laboratory values as specified in protocol.
Suitable venous access.
Recovered (that is, less than [< ] Grade 1 toxicity or participant's baseline status) from the reversible effects of prior anticancer therapy.
Exclusion Criteria:
Peripheral neuropathy greater than (>) Grade 2 on clinical examination.
Systemic treatment with strong inhibitors of cytochrome P450 (CYP) 1A2, strong inhibitors of CYP3A, or strong CYP3A inducers or use of ginkgo biloba or St. John's wort within 14 days before the first dose of IXAZOMIB.
Participant has symptomatic brain metastasis. Participants with brain metastases must: have stable neurologic status following surgery or radiation for at least 2 weeks after completion of the definitive therapy; and be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Female participants who are pregnant or lactating.
Serious illness that could interfere with protocol completion.
Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time.
Prior treatment with rituximab or other unconjugated any antibody treatment within 42 days (21 days if there is clear evidence of progressive disease or immediate treatment is mandated).
Ongoing treatment with corticosteroids.
Radiotherapy within 21 days before the first dose of study drug.
Major surgery within 14 days before the first dose of study drug.
Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to first dose of study drug.
Life-threatening illness unrelated to cancer.
Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive, or suspected hepatitis C infection.
Diagnosis or treatment of another malignancy within 2 years preceding first dose, or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Evidence of uncontrolled cardiovascular conditions.
QTc > 500 milliseconds on a 12-lead electrocardiogram (ECG).
Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of IXAZOMIB including difficulty swallowing capsules; diarrhea > Grade 1 despite supportive therapy.
Participants with gastric achlorhydria (Arm 1 only).
Participants who have used any nicotine containing products within 14 days before the first dose of study drug (Arm 1, Arm 4, and Arm 5).
Treatment with any investigational products or systemic antineoplastic therapies within 21 days before the first dose of IXAZOMIB.
Participants with known hypersensitivity to macrolide antibiotics (example, clarithromycin, erythromycin, azithromycin) or a history of jaundice/liver injury during prior exposure to clarithromycin (Arm 5 only).
Gupta N, Hanley MJ, Venkatakrishnan K, Bessudo A, Rasco DW, Sharma S, O'Neil BH, Wang B, Liu G, Ke A, Patel C, Rowland Yeo K, Xia C, Zhang X, Esseltine DL, Nemunaitis J. Effects of Strong CYP3A Inhibition and Induction on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor: Results of Drug-Drug Interaction Studies in Patients With Advanced Solid Tumors or Lymphoma and a Physiologically Based Pharmacokinetic Analysis. J Clin Pharmacol. 2018 Feb;58(2):180-192. doi: 10.1002/jcph.988. Epub 2017 Aug 11.
Participants with advanced nonhematologic malignancies or lymphoma were enrolled in this 5 arm study to receive one of the following treatments in Cycle 1: ixazomib + ketoconazole; ixazomib Capsule A or B formulation; ixazomib in fasted or fed state; ixazomib + rifampin; ixazomib + clarithromycin; Cycle 2 up to Cycle 12: ixazomib alone in all arms.
Recruitment Details
Participants took part in the study at 4 investigative sites in the United States from 10 November 2011 to 16 June 2016. An additional 1 center was activated but did not screen or enroll any participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ixazomib 4 mg Capsule B
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Experimental
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants will receive ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Drug: Rifampin
Drug: Ixazomib 4 mg Capsule B
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Experimental
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants will receive ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Drug: Ixazomib 2.5 mg
Drug: Ixazomib 4 mg Capsule B
Drug: Clarithromycin
Ixazomib 4 mg Capsule A
Drug
Ixazomib 4 mg Capsule A (Cycle 1 only)
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg Capsule B
Drug
Ixazomib 4 mg Capsule B (Cycle 2 and beyond )
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ketoconazole
Drug
Ketoconazole 400 mg tablets (Cycle 1 only)
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Rifampin
Drug
Rifampin 600 mg capsule (Cycle 1 only)
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Clarithromycin
Drug
Clarithromycin 500 mg tablets (Cycle 1 only)
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib 4 mg Capsule B
Drug
Ixazomib 4 mg Capsule B (Cycle 1 and beyond)
Arm 2: Ixazomib 4 mg Capsule A or B
Arm 3: Ixazomib 4 mg Fasted or Fed
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45
Number of Participants With Clinically Significant Vital Sign Abnormalities
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45
Percentage of Participants With Best Overall Response
Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 millimeter [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.
Baseline up to end of treatment (approximately 1.9 years)
Derived
Hanley MJ, Gupta N, Venkatakrishnan K, Bessudo A, Sharma S, O'Neil BH, Wang B, van de Velde H, Nemunaitis J. A Phase 1 Study to Assess the Relative Bioavailability of Two Capsule Formulations of Ixazomib, an Oral Proteasome Inhibitor, in Patients With Advanced Solid Tumors or Lymphoma. J Clin Pharmacol. 2018 Jan;58(1):114-121. doi: 10.1002/jcph.987. Epub 2017 Aug 7.
Gupta N, Hanley MJ, Venkatakrishnan K, Wang B, Sharma S, Bessudo A, Hui AM, Nemunaitis J. The Effect of a High-Fat Meal on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor, in Patients With Advanced Solid Tumors or Lymphoma. J Clin Pharmacol. 2016 Oct;56(10):1288-95. doi: 10.1002/jcph.719. Epub 2016 Mar 17.
FG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
FG002
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
FG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
FG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
FG00029 subjects
FG00120 subjects
FG00224 subjects
FG00318 subjects
FG00421 subjects
COMPLETED
FG00016 subjects
FG00114 subjects
FG00215 subjects
FG00316 subjects
FG00415 subjects
NOT COMPLETED
FG00013 subjects
FG0016 subjects
FG0029 subjects
FG0032 subjects
FG0046 subjects
Type
Comment
Reasons
Other
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Adverse Event
FG0008 subjects
FG0012 subjects
FG0027 subjects
FG0030 subjects
FG004
The safety population included all participants who received at least one dose of any study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
BG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
BG002
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
BG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
BG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00029
BG00120
BG00224
BG00318
BG00421
BG005112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00061.8± 8.71
BG00160.5± 13.33
BG00262.3± 11.86
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00029
BG00120
BG002
Height
Mean
Standard Deviation
centimeter (cm)
Title
Denominators
Categories
Title
Measurements
BG000166.6± 9.26
BG001166.4± 9.64
BG002
Weight
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
Title
Measurements
BG00077.44± 19.956
BG00169.78± 13.057
BG002
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
Cmax: Maximum Observed Plasma Concentration for Ixazomib
The pharmacokinetic (PK)-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Posted
Geometric Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
OG001
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
OG002
Arm 2: Ixazomib 4 mg Capsule A
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG003
Arm 2: Ixazomib 4 mg Capsule B
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG004
Arm 3: Ixazomib 4 mg Fasted
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG005
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG006
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
OG007
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
Units
Counts
Participants
OG00016
OG00116
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG00038.975± 21.3727
OG00139.250± 27.3318
OG00261.866± 48.3909
OG003
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Posted
Geometric Mean
Standard Deviation
nanogram*hour per milliliter (ng*hr/mL)]
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
OG001
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
OG002
Arm 2: Ixazomib 4 mg Capsule A
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
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 one dose of any study drug.
Posted
Number
participants
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Secondary
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities
The safety population included all participants who received at least one dose of any study drug.
Posted
Number
participants
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG002
Secondary
Number of Participants With Clinically Significant Vital Sign Abnormalities
The safety population included all participants who received at least one dose of any study drug.
Posted
Number
participants
Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG002
Secondary
Percentage of Participants With Best Overall Response
Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 millimeter [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.
The response-evaluable population included participants who had measurable disease at baseline, received at least 1 dose of any study drug, and had at least 1 postbaseline response assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to end of treatment (approximately 1.9 years)
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
Primary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Posted
Median
Full Range
hours
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
ID
Title
Description
OG000
Arm 1: Ixazomib 2.5 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
OG001
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
OG002
Arm 2: Ixazomib 4 mg Capsule A
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
Time Frame
Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
Description
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
12
29
28
29
EG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
5
20
20
20
EG002
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
12
24
23
24
EG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
3
18
18
18
EG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
10
21
20
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG0030 affected18 at risk
EG0040 affected21 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected20 at risk
EG0020 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Rectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Malignant peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Ovarian cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Face oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Laryngeal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Syncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Interstitial granulomatous dermatitis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Seasonal allergy
Immune system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG0031 affected18 at risk
EG0040 affected21 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Eye swelling
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Eye discharge
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Visual impairment
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected20 at risk
EG0021 affected24 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Hot flush
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected29 at risk
EG0012 affected20 at risk
EG0022 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Depression
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected20 at risk
EG0020 affected24 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Tremor
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected29 at risk
EG0014 affected20 at risk
EG0026 affected24 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0006 affected29 at risk
EG0012 affected20 at risk
EG0022 affected24 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0023 affected24 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Weight decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected20 at risk
EG0026 affected24 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0024 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected20 at risk
EG0021 affected24 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Platelet count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Blood creatine increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0013 affected20 at risk
EG0021 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0024 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0013 affected20 at risk
EG0024 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected20 at risk
EG0025 affected24 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0013 affected20 at risk
EG0022 affected24 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0013 affected20 at risk
EG0021 affected24 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected20 at risk
EG0021 affected24 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Skin wrinkling
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected29 at risk
EG0012 affected20 at risk
EG0024 affected24 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected20 at risk
EG0023 affected24 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected20 at risk
EG0021 affected24 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Tongue atrophy
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG00013 affected29 at risk
EG0017 affected20 at risk
EG0026 affected24 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected20 at risk
EG0025 affected24 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected20 at risk
EG0024 affected24 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0022 affected24 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG00020 affected29 at risk
EG0017 affected20 at risk
EG0029 affected24 at risk
EG003
Asthenia
General disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected29 at risk
EG0014 affected20 at risk
EG0025 affected24 at risk
EG003
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected29 at risk
EG0012 affected20 at risk
EG0022 affected24 at risk
EG003
Malaise
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected20 at risk
EG0020 affected24 at risk
EG003
Gait disturbance
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0021 affected24 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Peripheral swelling
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0021 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Device occlusion
Product Issues
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected20 at risk
EG0022 affected24 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected20 at risk
EG0020 affected24 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected20 at risk
EG0020 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Takeda
+1-877-825-3327
trialdisclosures@takeda.com
ID
Term
D008223
Lymphoma
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C548400
ixazomib
D007654
Ketoconazole
D012293
Rifampin
D017291
Clarithromycin
Ancestor Terms
ID
Term
D010879
Piperazines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D012294
Rifamycins
D006576
Heterocyclic Compounds, 4 or More Rings
D000072471
Heterocyclic Compounds, Fused-Ring
D047029
Lactams, Macrocyclic
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D004917
Erythromycin
D018942
Macrolides
D061065
Polyketides
D007783
Lactones
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
2 subjects
61.6
± 11.33
BG00460.0± 11.04
BG00561.3± 11.01
11
BG0038
BG0046
BG00553
Male
BG00012
BG0019
BG00213
BG00310
BG00415
BG00559
3
BG0031
BG0044
BG00516
Not Hispanic or Latino
BG00026
BG00115
BG00221
BG00317
BG00417
BG00596
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0040
BG0050
Asian
BG0000
BG0010
BG0020
BG0031
BG0041
BG0052
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0005
BG0012
BG0024
BG0030
BG0040
BG00511
White
BG00022
BG00115
BG00218
BG00317
BG00419
BG00591
More than one race
BG0001
BG0011
BG0021
BG0030
BG0041
BG0054
Unknown or Not Reported
BG0001
BG0012
BG0021
BG0030
BG0040
BG0054
24
BG00318
BG00421
BG005112
170.2
± 9.76
BG003169.2± 10.03
BG004172.6± 11.11
BG005168.9± 10.00
74.09
± 16.358
BG00380.22± 17.183
BG00481.93± 20.973
BG00576.64± 18.083
14
OG00415
OG00515
OG00616
OG00715
71.949
± 46.2132
OG00477.001± 53.5905
OG00522.752± 15.0506
OG00625.706± 15.1435
OG00737.245± 21.4416
OG003
Arm 2: Ixazomib 4 mg Capsule B
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG004
Arm 3: Ixazomib 4 mg Fasted
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG005
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG006
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
OG007
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
Units
Counts
Participants
OG00016
OG00116
OG00214
OG00314
OG00415
OG00515
OG00616
OG00715
Title
Denominators
Categories
Title
Measurements
OG000551.985± 191.4490
OG0011148.778± 581.4376
OG0021284.079± 941.4838
OG0031334.659± 1244.0951
OG0041465.979± 812.0514
OG005998.698± 1019.1868
OG006231.527± 134.9720
OG007613.112± 375.0216
OG002
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). Participant received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00029
OG00120
OG00224
OG00318
OG00421
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00029
OG00120
OG00224
OG00318
OG00421
SAEs
Title
Measurements
OG00012
OG0015
OG00212
OG003
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00029
OG00120
OG00224
OG00318
OG00421
Title
Denominators
Categories
Blood and lymphatic system disorders
Title
Measurements
OG00011
OG0017
OG0029
OG0032
OG0041
Investigations
Title
Measurements
OG00010
OG0015
OG00211
OG003
Metabolism and nutrition disorders
Title
Measurements
OG00022
OG00112
OG00213
OG003
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00029
OG00120
OG00224
OG00318
OG00421
Title
Denominators
Categories
Title
Measurements
OG0000± 0.324
OG0010
OG0020
OG0030
OG0040
OG001
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG002
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG003
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
OG004
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00016
OG00114
OG00217
OG00317
OG00418
Title
Denominators
Categories
CR
Title
Measurements
OG0000(0.0 to 20.6)
OG0010(0.0 to 23.2)
OG0020(0.0 to 19.5)
OG0030(0.0 to 19.5)
OG0040(0.0 to 4.5)
PR
Title
Measurements
OG0000(0.0 to 20.6)
OG0010(0.0 to 23.2)
OG0026(0.1 to 28.7)
OG003
SD
Title
Measurements
OG00063(35.4 to 84.8)
OG00150(23.0 to 77.0)
OG00235(14.2 to 61.7)
OG003
PD
Title
Measurements
OG00038(15.2 to 64.6)
OG00150(23.0 to 77.0)
OG00259(32.9 to 81.6)
OG003
OG003
Arm 2: Ixazomib 4 mg Capsule B
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG004
Arm 3: Ixazomib 4 mg Fasted
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG005
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
OG006
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
OG007
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).