Dose Escalation Study of MLN0128 in Participants With Adv... | NCT01058707 | Trialant
NCT01058707
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Apr 1, 2020Actual
Enrollment
198Actual
Phase
Phase 1
Conditions
Advanced Solid Malignancies
Interventions
MLN0128
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
NCT01058707
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INK128-001
Secondary IDs
ID
Type
Description
Link
2009-017284-42
EudraCT Number
U1111-1187-4258
Other Identifier
World Health Organization
Brief Title
Dose Escalation Study of MLN0128 in Participants With Advanced Malignancies
Official Title
A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent INK128 in Subjects With Advanced Malignancies Followed by an Expansion in Subjects With Measurable Disease
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Mar 2020
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
Jan 4, 2010Actual
Primary Completion Date
Feb 7, 2019Actual
Completion Date
Feb 7, 2019Actual
First Submitted Date
Jan 27, 2010
First Submission Date that Met QC Criteria
Jan 27, 2010
First Posted Date
Jan 29, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 4, 2020
Results First Submitted that Met QC Criteria
Mar 18, 2020
Results First Posted Date
Apr 1, 2020Actual
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
Mar 18, 2020
Last Update Posted Date
Apr 1, 2020Actual
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 a Phase I, open label, Dose Escalation study of oral administration of single agent MLN0128 in participants with Advanced Malignancies followed by an Expansion Phase in participants with renal cell carcinoma, endometrial cancer or urothelial cancer who have measurable disease.
Detailed Description
The drug being tested in this study is called MLN0128. MLN0128 is being tested to treat people who have Advanced Malignancies.
The study enrolled approximately 198 patients. Participants were assigned to one of the following dose regimens in the Dose Escalation Phase to establish the Maximum Tolerated Dose (MTD):
MLN0128 QD
MLN0128 QW
MLN0128 QDx3dQW
MLN0128 QDx5dQW
MLN0128 capsule, orally, once daily (QD) or Once weekly (QW) in the Dose Escalation Phase until MTD was established.
Once MTD was determined, participants were then enrolled in the Dose Expansion Phase to receive:
MLN0128 5 mg QD
MLN0128 30 mg QW
MLN0128 40 mg QW
This multi-centre trial was conducted worldwide. The overall time to participate in this study was approximately 244 weeks. Participants will make multiple visits to the clinic, and were contacted by telephone OR plus a final visit after last dose of study drug for a follow-up assessment.
Conditions Module
Conditions
Advanced Solid Malignancies
Keywords
Solid tumors, MLN0128, TORC1/2 inhibitors
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
198Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MLN0128 QD
Experimental
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
Drug: MLN0128
MLN0128 QW
Experimental
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
Drug: MLN0128
MLN0128 QDx3d QW
Experimental
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
Drug: MLN0128
MLN0128 QDx5d QW
Experimental
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
Drug: MLN0128
MLN0128 5 mg QD
Experimental
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MLN0128
Drug
MLN0128 capsules
MLN0128 30 mg QW
MLN0128 40 mg QW
MLN0128 5 mg QD
MLN0128 QD
MLN0128 QDx3d QW
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Phase: Maximum Tolerated Dose (MTD)
MTD was defined as the highest dose level of MLN0128 at which no more than 1 out of 6 evaluable participants experienced a DLT during the first cycle (28 days) of therapy.
Cycle 1 (28 Days)
Dose Escalation Phase: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as MLN0128-related treatment-emergent adverse events (TEAEs) that occurred within the Cycle 1 (first 28 days of treatment) as per Common Terminology Criteria for Adverse Events (CTCAE): Any ≥Grade 3 or non-hematologic toxicity except for Grade 3 nausea and/or vomiting and diarrhea, Grade 3 hyperglycemia lasting ≤ 14 days, Grade 3 rash lasting ≤ 3 days; Grade 4 neutropenia lasting >7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever ≥38.5 degree celsius and/or systemic infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75% of planned doses of MLN0128 within Cycle 1 due to drug-related toxicity and any clinically significant occurrence that the investigators and sponsor agreed would place participants at an undue safety risk.
Cycle 1 (28 days)
Number of Participants Experiencing One or More Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 244 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Cmax: Maximum Observed Plasma Concentration for MLN0128
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
Ctrough: Observed Concentration at the End of a Dosing Interval
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Voluntary written consent
Locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed standard of care therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Ability to swallow oral medications
For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 90 days following the last study drug administration
Male participants must be surgically sterile or must agree to use physician-approved contraception during the study and for 90 days following the last study drug administration
Clinical laboratory values as specified in the protocol
Additionally, to be eligible for the Dose Expansion portion of the study:
Participants must have evidence of measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1 by radiographic techniques or magnetic resonance imaging
Participants must have a pathologic diagnosis of advanced or recurrent endometrial adenocarcinoma and must have failed at least 1 prior line of standard chemotherapy
Participants must have a pathologic diagnosis of advanced/metastatic urothelial cancer (carcinoma of the bladder, ureter, and/or renal pelvis) and must have failed at least 1 line of prior therapy in the metastatic/unresectable setting
Participants must have a pathologic diagnosis of advanced renal cell carcinoma (RCC), with histological or cytological confirmation of RCC and must have failed at least 1 prior line of anti-vascular endothelial growth factor therapy (VEGF) therapy (including but not limited to sunitinib, and/or sorafenib, and/or bevacizumab and/or pazopanib, and/or axitinib) and must not have received prior therapy with a target of rapamycin complex 1 (TORC1) inhibitor (such as temsirolimus or everolimus); or
Participants must have a pathologic diagnosis of advanced renal cell carcinoma (RCC) and must have progressed on treatment with a TORC1 inhibitor (such as temsirolimus or everolimus).
Exclusion Criteria:
Diagnosis of primary brain tumor
Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug
Known impaired cardiac function or clinically significant cardiac disease
Known treatment with systemic corticosteroid within one week prior to the first administration of study drug
Diabetes mellitus
Human immunodeficiency virus (HIV) infection
Known active cardiovascular disease condition as specified in protocol
Failed to recover from the reversible effects of prior anticancer therapies
Pregnancy (positive serum or urine pregnancy test) or breast feeding
Malabsorption due to prior gastrointestinal (GI) surgery, GI disease
Other clinically significant co-morbidities
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Voss MH, Gordon MS, Mita M, Rini B, Makker V, Macarulla T, Smith DC, Cervantes A, Puzanov I, Pili R, Wang D, Jalal S, Pant S, Patel MR, Neuwirth RL, Enke A, Shou Y, Sedarati F, Faller DV, Burris HA 3rd. Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or bladder cancer. Br J Cancer. 2020 Nov;123(11):1590-1598. doi: 10.1038/s41416-020-01041-x. Epub 2020 Sep 11.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants with a diagnosis of advanced malignancies were enrolled and received rising doses of MLN0128 in the Dose Escalation Phase to determine Maximum Tolerated Dose (MTD). In the Dose Expansion Phase participants were enrolled to receive one of 3 dose regimens: MLN0128 5 mg once daily (QD), 30 mg once weekly (QW) or 40 mg QW.
Recruitment Details
Participants took part in the study at 15 investigative sites in Spain and the United States from 4 January 2010 to 7 February 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
FG001
MLN0128 QW
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 17, 2018
Feb 4, 2020
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
The Escalation Phase was sequential and the Expansion Phase was parallel.
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: MLN0128
MLN0128 30 mg QW
Experimental
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
Drug: MLN0128
MLN0128 40 mg QW
Experimental
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
Drug: MLN0128
MLN0128 QDx5d QW
MLN0128 QW
INK128
TAK-128
Dose Expansion: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR is defined as disappearance of all target lesions and PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. Data was categorized as per type of cancer.
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
Dose Expansion Phase: Duration of Objective Response
Duration of objective response is defined as the number of months from the start date of CR or PR (whichever occurred first) based on RECIST Criteria version 1.1 to the first date of objectively documented progressive disease (PD) for participants who achieved CR or PR. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
Dose Expansion: Duration of Stable Disease (SD)
Duration of SD was evaluated for participants with best response of SD and is defined as number of months from date of first dose to date of PD. As per RECIST 1.1, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined of at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. PD is defined as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is smallest on study).
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
Terminal Phase Elimination Half-life (T1/2) for MLN0128
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN0128
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
Tmax: Time to Maximum Observed Plasma Concentration for MLN0128
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
Percentage Area Under Plasma Concentration Time Curve Extrapolated
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
Percentage Change From Baseline in Eukaryotic Initiation Factor 4E-binding Protein 1 (P4EBP1), Serine/Threonine Protein Kinase B (PAKT) and Ribosomal Protein S6 (PS6)
P4EBP, PAKT and PS6 were assayed in skin biopsies. A negative percentage change from Baseline indicates improvement.
Baseline, Cycle 1 Week 2
Los Angeles
California
United States
Miami
Florida
United States
Sarasota
Florida
United States
Indianapolis
Indiana
United States
Boston
Massachusetts
United States
Ann Arbor
Michigan
United States
Detroit
Michigan
United States
Buffalo
New York
United States
New York
New York
United States
Cleveland
Ohio
United States
Oklahoma City
Oklahoma
United States
Philadelphia
Pennsylvania
United States
Nashville
Tennessee
United States
Barcelona
Spain
Valencia
Spain
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
FG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
FG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
FG004
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
FG005
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
FG006
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
FG00031 subjects
FG00130 subjects
FG00233 subjects
FG00322 subjects
FG00439 subjects
FG00517 subjects
FG00626 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00031 subjects
FG00130 subjects
FG00233 subjects
FG00322 subjects
FG00439 subjects
FG00517 subjects
FG00626 subjects
Type
Comment
Reasons
Disease Progression
FG00015 subjects
FG00120 subjects
FG00220 subjects
FG00315 subjects
FG00423 subjects
FG00510 subjects
FG00612 subjects
Adverse Event
FG00011 subjects
FG0014 subjects
FG0027 subjects
FG0036 subjects
FG004
Subject Decision
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason Not Specified
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
All Participants as Treated (ASaT) population included all participants who received at least 1 dose of MLN0128.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
BG001
MLN0128 QW
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
BG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
BG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
BG004
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
BG005
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
BG006
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00130
BG00233
BG00322
BG00439
BG00517
BG00626
BG007198
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00059.7(24 to 75)
BG00153.8(34 to 89)
BG00256.1(36 to 87)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG00118
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00021
BG00118
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
Dose Escalation Phase: Maximum Tolerated Dose (MTD)
MTD was defined as the highest dose level of MLN0128 at which no more than 1 out of 6 evaluable participants experienced a DLT during the first cycle (28 days) of therapy.
Dose Escalation-Evaluable Population included participants who received ≥ 75% or more of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs considered a DLT.
Posted
Number
milligrams (mg)
Cycle 1 (28 Days)
ID
Title
Description
OG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
OG001
MLN0128 QW
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
OG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
OG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
Units
Counts
Participants
OG00025
OG00127
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG00140
OG0029
OG003
Primary
Dose Escalation Phase: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as MLN0128-related treatment-emergent adverse events (TEAEs) that occurred within the Cycle 1 (first 28 days of treatment) as per Common Terminology Criteria for Adverse Events (CTCAE): Any ≥Grade 3 or non-hematologic toxicity except for Grade 3 nausea and/or vomiting and diarrhea, Grade 3 hyperglycemia lasting ≤ 14 days, Grade 3 rash lasting ≤ 3 days; Grade 4 neutropenia lasting >7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever ≥38.5 degree celsius and/or systemic infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75% of planned doses of MLN0128 within Cycle 1 due to drug-related toxicity and any clinically significant occurrence that the investigators and sponsor agreed would place participants at an undue safety risk.
Dose Escalation-Evaluable Population included participants who received ≥ 75% or more of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs considered a DLT.
Posted
Count of Participants
Participants
Cycle 1 (28 days)
ID
Title
Description
OG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
OG001
MLN0128 QW
Primary
Number of Participants Experiencing One or More Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
ASaT population included all participants who received at least 1 dose of MLN0128.
Posted
Count of Participants
Participants
First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 244 weeks)
ID
Title
Description
OG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
OG001
MLN0128 QW
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
Primary
Dose Expansion: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR is defined as disappearance of all target lesions and PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. Data was categorized as per type of cancer.
Response-Evaluable Population included participants who received at least 1 dose of MLN0128, had measurable disease at Baseline, and underwent at least 1 post-Baseline disease assessment. Participants without a post-Baseline disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included.
Posted
Number
percentage of participants
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
ID
Title
Description
OG000
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
OG001
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG002
Primary
Dose Expansion Phase: Duration of Objective Response
Duration of objective response is defined as the number of months from the start date of CR or PR (whichever occurred first) based on RECIST Criteria version 1.1 to the first date of objectively documented progressive disease (PD) for participants who achieved CR or PR. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Response-Evaluable Population:participants who received ≥1 dose of MLN0128,had measurable disease at Baseline,had ≥1 post-Baseline disease assessment.Participants without post-Baseline disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included.CR/PR participants with available data were analyzed.
Posted
Median
Full Range
months
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
ID
Title
Description
OG000
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
OG001
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
Primary
Dose Expansion: Duration of Stable Disease (SD)
Duration of SD was evaluated for participants with best response of SD and is defined as number of months from date of first dose to date of PD. As per RECIST 1.1, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined of at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. PD is defined as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is smallest on study).
Response-Evaluable Population: participants who received ≥1 dose of MLN0128, had measurable disease at Baseline (BL), underwent ≥1 post-BL disease assessment. Participants without post-BL disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included. SD participants with available data were analyzed.
Posted
Median
Full Range
months
From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)
ID
Title
Description
OG000
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
OG001
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
Secondary
Cmax: Maximum Observed Plasma Concentration for MLN0128
Pharmacokinetic (PK) population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
Full Range
ng/mL
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
MLN0128 7 mg QW
Secondary
Ctrough: Observed Concentration at the End of a Dosing Interval
PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
Full Range
ng/mL
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
MLN0128 7 mg QW
Secondary
Terminal Phase Elimination Half-life (T1/2) for MLN0128
PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Median
Full Range
hours
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
MLN0128 7 mg QW
Secondary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128
PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
Full Range
ng*hr/mL
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
Secondary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN0128
PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
Full Range
ng*hr/mL
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
Secondary
Tmax: Time to Maximum Observed Plasma Concentration for MLN0128
PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Median
Full Range
hours
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
MLN0128 7 mg QW
Secondary
Percentage Area Under Plasma Concentration Time Curve Extrapolated
The study was acquired from another organization and limited results data are available.
Posted
Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2
ID
Title
Description
OG000
MLN0128 2 mg QD
MLN0128 2 mg capsule, orally, QD in 28-day cycle (Up to 10.1 weeks).
OG001
MLN0128 4 mg QD
MLN0128 4 mg capsule, orally, QD in 28-day cycle (Up to 14.0 weeks)
OG002
MLN0128 6 mg QD
MLN0128 6 mg capsule, orally, QD in 28-day cycle (Up to 32.0 weeks).
OG003
MLN0128 7 mg QD
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 52.1 weeks).
OG004
MLN0128 7 mg QW
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
Secondary
Percentage Change From Baseline in Eukaryotic Initiation Factor 4E-binding Protein 1 (P4EBP1), Serine/Threonine Protein Kinase B (PAKT) and Ribosomal Protein S6 (PS6)
P4EBP, PAKT and PS6 were assayed in skin biopsies. A negative percentage change from Baseline indicates improvement.
ASaT population included all participants who received at least 1 dose of MLN0128 in dose escalation phase. Participants with data at Baseline and Cycle 1 Week 2 are included. Number analyzed is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percentage change
Baseline, Cycle 1 Week 2
ID
Title
Description
OG000
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
OG001
MLN0128 QW
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
OG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
Time Frame
All cause-mortality were collected throughout the study; SAEs and Other (non-serious) were collected from the first dose of study drug plus 30 days after last dose of study drug (Up to approximately 244 weeks)
Description
Not provided
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
MLN0128 QD
MLN0128 2 mg, 4 mg, 6 mg or 7 mg, capsule, orally, once daily (QD) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 52.1 weeks).
3
31
13
31
31
31
EG001
MLN0128 QW
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
2
30
10
30
30
30
EG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
2
33
17
33
33
33
EG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
0
22
10
22
22
22
EG004
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
2
39
19
39
39
39
EG005
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
2
17
6
17
17
17
EG006
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
3
26
9
26
26
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Stomatitis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0024 affected33 at risk
EG0032 affected22 at risk
EG0040 affected39 at risk
EG0050 affected17 at risk
EG0061 affected26 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 10 mg QW escalation phase and is not related. One treatment-emergent death occurred during treatment with MLN0128 9 mg QDx3dQW escalation phase and is not related.
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 12 mg QDx3dQW escalation phase and is not related.
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Intestinal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 7 mg QD escalation phase and is not related.
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Device related infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Sepsis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 30 mg QW expansion phase and is not related.
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Asthenia
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0023 affected33 at risk
EG003
General physical health deterioration
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 6 mg QD in escalation phase and is not related.
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 6 mg QD escalation phase and is related.
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 6 mg QD escalation phase and is related.
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Seizure
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Carcinoid syndrome
Endocrine disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Cystitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 40 mg QW expansion phase and is not related.
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Disease progression
General disorders
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 40 mg QW expansion phase and is not related.
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Fatigue
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 30 mg QW expansion phase and is not related. One treatment-emergent death occurred during treatment with MLN0128 40 mg QW expansion phase and is not related.
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
One treatment-emergent death occurred during treatment with MLN0128 5 mg QD expansion phase and is not related.
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Delirium
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG00016 affected31 at risk
EG00122 affected30 at risk
EG00224 affected33 at risk
EG00313 affected22 at risk
EG00421 affected39 at risk
EG00512 affected17 at risk
EG00620 affected26 at risk
Vomiting
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG00012 affected31 at risk
EG00120 affected30 at risk
EG00220 affected33 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG00011 affected31 at risk
EG00110 affected30 at risk
EG00222 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG00014 affected31 at risk
EG00110 affected30 at risk
EG00217 affected33 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0008 affected31 at risk
EG0017 affected30 at risk
EG0023 affected33 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0016 affected30 at risk
EG0024 affected33 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0016 affected30 at risk
EG0026 affected33 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0023 affected33 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG00026 affected31 at risk
EG00118 affected30 at risk
EG00222 affected33 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG00013 affected31 at risk
EG00112 affected30 at risk
EG00220 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0005 affected31 at risk
EG0016 affected30 at risk
EG0026 affected33 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected30 at risk
EG0022 affected33 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0005 affected31 at risk
EG0011 affected30 at risk
EG0024 affected33 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected30 at risk
EG0024 affected33 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected30 at risk
EG0024 affected33 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Hypocholesterolaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Asthenia
General disorders
MedDRA: 18.0
Systematic Assessment
EG0007 affected31 at risk
EG00115 affected30 at risk
EG00213 affected33 at risk
EG003
Fatigue
General disorders
MedDRA: 18.0
Systematic Assessment
EG00010 affected31 at risk
EG0019 affected30 at risk
EG00215 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0019 affected30 at risk
EG0028 affected33 at risk
EG003
Chills
General disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected30 at risk
EG0023 affected33 at risk
EG003
Oedema peripheral
General disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0014 affected30 at risk
EG0020 affected33 at risk
EG003
Chest pain
General disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Performance status decreased
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0018 affected30 at risk
EG0029 affected33 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0009 affected31 at risk
EG0014 affected30 at risk
EG0024 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected30 at risk
EG0025 affected33 at risk
EG003
Tremor
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected30 at risk
EG0023 affected33 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Somnolence
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG00010 affected31 at risk
EG0014 affected30 at risk
EG0027 affected33 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG00010 affected31 at risk
EG0010 affected30 at risk
EG0026 affected33 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0013 affected30 at risk
EG0021 affected33 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0004 affected31 at risk
EG0010 affected30 at risk
EG0023 affected33 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG00113 affected30 at risk
EG0023 affected33 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected30 at risk
EG0024 affected33 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected30 at risk
EG0023 affected33 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected30 at risk
EG0020 affected33 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected30 at risk
EG0026 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0015 affected30 at risk
EG0021 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0023 affected33 at risk
EG003
Oral herpes
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0024 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0017 affected30 at risk
EG00210 affected33 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0015 affected30 at risk
EG0024 affected33 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected30 at risk
EG0021 affected33 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0021 affected33 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0020 affected33 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected30 at risk
EG0021 affected33 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Blood creatinine increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0009 affected31 at risk
EG0014 affected30 at risk
EG0023 affected33 at risk
EG003
Weight decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0013 affected30 at risk
EG0025 affected33 at risk
EG003
Blood urea increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected30 at risk
EG0020 affected33 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Platelet count decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Blood albumin decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Blood urea decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected30 at risk
EG0020 affected33 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0006 affected31 at risk
EG0015 affected30 at risk
EG00210 affected33 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0005 affected31 at risk
EG0014 affected30 at risk
EG0023 affected33 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0005 affected31 at risk
EG0011 affected30 at risk
EG0021 affected33 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0005 affected31 at risk
EG0011 affected30 at risk
EG0023 affected33 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected30 at risk
EG0023 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected30 at risk
EG0024 affected33 at risk
EG003
Depression
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Agitation
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected30 at risk
EG0020 affected33 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0022 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0015 affected30 at risk
EG0022 affected33 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0021 affected33 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Palpitations
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0022 affected33 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected30 at risk
EG0020 affected33 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA: 18.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0022 affected33 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Rectal obstruction
Gastrointestinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected30 at risk
EG0028 affected33 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Malaise
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pain
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Early satiety
General disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Sciatica
Nervous system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Blood potassium increased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
White blood cell count decreased
Investigations
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Flushing
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Phlebitis
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Vision blurred
Eye disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Blindness transient
Eye disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Device breakage
Product Issues
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA: 18.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected30 at risk
EG0020 affected33 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
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
MLN0128 7 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg capsule, orally, once weekly (QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 139.4 weeks).
OG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
OG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
Units
Counts
Participants
OG00025
OG00127
OG00229
OG00322
Title
Denominators
Categories
Title
Measurements
OG0007
OG0012
OG0026
OG0037
OG002
MLN0128 QDx3d QW
MLN0128 6 mg, 9 mg, 12 mg, 16 mg or 20 mg capsule, orally, once daily every 3 days a week (QDx3d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 129.4 weeks).
OG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).
OG004
MLN0128 5 mg QD
MLN0128 5 mg, capsule, orally, QD in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 98.3 weeks).
OG005
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG006
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
Units
Counts
Participants
OG00031
OG00130
OG00233
OG00322
OG00439
OG00517
OG00626
Title
Denominators
Categories
TEAE
Title
Measurements
OG00031
OG00130
OG00233
OG00322
OG00439
OG00517
OG00626
SAE
Title
Measurements
OG00013
OG00110
OG00217
OG003
AEs Resulting in Discontinuation of MLN0128
Title
Measurements
OG00011
OG0014
OG0027
OG003
Fatal AEs within 30 Days of Last Dose Study Drug
Title
Measurements
OG0001
OG0011
OG0022
OG003
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
Units
Counts
Participants
OG00036
OG00114
OG00222
Title
Denominators
Categories
Cancer Type: Renal
ParticipantsOG00020
ParticipantsOG0018
ParticipantsOG00213
Title
Measurements
OG00015
OG00113
OG00215
Cancer Type: Endometrial
ParticipantsOG00011
ParticipantsOG0014
ParticipantsOG0023
Title
Measurements
OG000
Cancer Type: Bladder
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0026
Title
Measurements
OG000
OG002
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
Units
Counts
Participants
OG0004
OG0011
OG0022
Title
Denominators
Categories
Title
Measurements
OG0008.90(3.48 to 23.06)
OG00156.05(56.05 to 56.05)
OG00220.73(20.24 to 21.22)
OG002
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
Units
Counts
Participants
OG00019
OG0015
OG00211
Title
Denominators
Categories
Title
Measurements
OG0003.68(0.95 to 14.88)
OG0012.20(0.76 to 5.45)
OG0023.55(1.18 to 13.08)
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG00212
ParticipantsOG0038
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG00915
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0126
ParticipantsOG01311
ParticipantsOG0144
ParticipantsOG0156
ParticipantsOG01611
ParticipantsOG0173
Title
Measurements
OG00013.7(12.30 to 16.30)
OG00120.5(9.54 to 35.70)
OG00248.9(18.60 to 75.60)
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0033
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0126
ParticipantsOG01311
ParticipantsOG0144
ParticipantsOG0156
ParticipantsOG0169
ParticipantsOG0173
Title
Measurements
OG0000.9(0.00 to 2.76)
OG0011.2(0.00 to 2.48)
OG0023.5(0.00 to 8.84)
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0033
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG0034
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG00914
ParticipantsOG0102
ParticipantsOG0115
ParticipantsOG0126
ParticipantsOG0138
ParticipantsOG0142
ParticipantsOG0156
ParticipantsOG0168
ParticipantsOG0172
Title
Measurements
OG00010.3(10.30 to 10.30)
OG0017.4(5.27 to 8.22)
OG0026.3(4.86 to 10.40)
OG003
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0033
MLN0128 7 mg QW
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG0034
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG00914
ParticipantsOG0102
ParticipantsOG0115
ParticipantsOG0126
ParticipantsOG0138
ParticipantsOG0142
ParticipantsOG0156
ParticipantsOG0168
ParticipantsOG0172
Title
Measurements
OG000185.00(185.00 to 185.00)
OG001205.3(145.00 to 269.00)
OG002390.6(263.00 to 608.00)
OG003
Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MLN0128 7 mg QW
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0120
ParticipantsOG0132
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0161
ParticipantsOG0170
Title
Measurements
OG00065.4(64.00 to 66.80)
OG00165.3(51.60 to 89.80)
OG00295.30(95.30 to 95.30)
OG004
Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
MLN0128 7 mg, capsule, orally QD in 28-day cycle (Up to 7.0 weeks).
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle (Up to 139.4 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0003
OG0017
OG00212
OG0038
OG0043
OG0053
OG0063
OG0073
OG0083
OG00915
OG0103
OG0118
OG0126
OG01311
OG0144
OG0156
OG01611
OG0173
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG00212
ParticipantsOG0038
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG00915
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0126
ParticipantsOG01311
ParticipantsOG0144
ParticipantsOG0156
ParticipantsOG01611
ParticipantsOG0173
Title
Measurements
OG0002.0(2.00 to 2.05)
OG0012.0(0.98 to 4.00)
OG0021.0(0.50 to 4.17)
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0033
OG005
MLN0128 10 mg QW
MLN0128 10 mg, capsule, orally QW in 28-day cycle (Up to 15.1 weeks).
OG006
MLN0128 15 mg QW
MLN0128 15 mg, capsule, orally QW in 28-day cycle (Up to 7.1 weeks).
OG007
MLN0128 20 mg QW
MLN0128 20 mg, capsule, orally QW in 28-day cycle (Up to 10.1 weeks).
OG008
MLN0128 30 mg QW
MLN0128 30 mg, capsule, orally QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 240 weeks).
OG009
MLN0128 40 mg QW
MLN0128 40 mg, capsule, orally, QW in 28-day cycle until disease progression or unacceptable toxicity in the Dose Expansion Phase (Up to 100.1 weeks).
OG010
MLN0128 6 mg QDx3dQW
MLN0128 6 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 8.4 weeks).
OG011
MLN0128 9 mg QDx3d QW
MLN0128 9 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 129.4 weeks).
OG012
MLN0128 12 mg QDx3d QW
MLN0128 12 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 11.4 weeks).
OG013
MLN0128 16 mg QDx3d QW
MLN0128 16 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 31.4 weeks).
OG014
MLN0128 20 mg QDx3dQW
MLN0128 20 mg, capsule, orally QDx3d QW in 28-day cycle (Up to 7.4 weeks).
OG015
MLN0128 7 mg QDx5dQW
MLN0128 7 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 15.9 weeks).
OG016
MLN0128 10 mg QDx5dQW
MLN0128 10 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 161.9 weeks).
OG017
MLN0128 13 mg QDx5dQW
MLN0128 13 mg, capsule, orally QDx5d QW in 28-day cycle (Up to 7.7 weeks).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG003
MLN0128 QDx5d QW
MLN0128 7 mg, 10 mg or 13 mg capsule, orally, once daily every 5 days a week (QDx5d QW) in 28-day cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 161.9 weeks).