A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Official Title
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients With Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.
Expanded Access Info
No
Start Date
Apr 23, 2018Actual
Primary Completion Date
Feb 27, 2020Actual
Completion Date
Feb 27, 2020Actual
First Submitted Date
Feb 22, 2018
First Submission Date that Met QC Criteria
Feb 22, 2018
First Posted Date
Feb 28, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2021
Results First Submitted that Met QC Criteria
Feb 24, 2021
Results First Posted Date
Mar 22, 2021Actual
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
Feb 24, 2021
Last Update Posted Date
Mar 22, 2021Actual
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
The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
Detailed Description
The drug being tested in this study is a novel antibody-drug conjugate (ADC) called TAK-164. TAK-164 is being evaluated in participants with advanced GCC-positive GI cancer (Part A) or colorectal carcinoma (CRC) and gastric carcinoma (Part B and Part C) to determine safety, tolerability, and pharmacokinetics (PK) and MTD/RP2D of TAK-164, as well as the preliminary efficacy. The study will include approximately 100 evaluable participants.
In Part A (Escalation), approximately 25 participants with GI carcinoma will be enrolled. Those include participants with various GI malignancies such as carcinomas of esophagus, stomach, colon, and pancreas. The starting dose for Arm 1 will be 0.004 mg/kg of TAK-164 administered intravenously on Day 1 Q3W and the maximal dose will not exceed 0.19 mg/kg Q3W.
In Part B (Expansion), approximately 50 participants will be enrolled to receive TAK-164 infusion at determined RP2D in Part A. Participants will follow the Q3W schedule and will be followed until PD, unacceptable toxicity, or until they choose to withdraw consent.
In Part C (Imaging substudy to be conducted in the Netherlands only), approximately 25 participants with GCC-expressing metastatic colorectal carcinoma (mCRC) will be enrolled to receive 89Zr-TAK-164 and unlabeled TAK-164 at determined RP2D in Part A.
This multi-center trial will be conducted in the United States and the Netherlands. The overall time to participate in this study is up to 55 months. Participants will attend an end of study (EOS) visit 30 days after the last dose of TAK-164 or just prior to the start of subsequent antineoplastic therapy, whichever occurs first.
TAK-164 0.004 milligram per kilogram (mg/kg) starting dose, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. Dose escalation will be performed to determine the MTD and/or RP2D.
Drug: TAK-164
Part B Expansion Stage: TAK-164 Q3W
Experimental
TAK-164, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. TAK-164 RP2D dose to be decided based on safety, PK, pharmacodynamics and antitumor response data observed in Part A escalation stage.
Drug: TAK-164
Part C Imaging Substudy: 89Zr-TAK-164 and TAK-164
Experimental
89Zr-TAK-164, intravenous infusion, followed by unlabeled TAK-164, intravenous infusion in combination with 89Zr-TAK-164, intravenous infusion, and further followed by unlabeled TAK-164, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. TAK-164 recommended imaging dose (RID) or RP2D dose to be decided based on safety, PK, PD and antitumor response data observed in Part A escalation stage.
Drug: TAK-164
Drug: 89Zr-TAK-164
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-164
Drug
TAK-164 intravenous infusion.
Part A Escalation Stage: TAK-164 Q3W
Part B Expansion Stage: TAK-164 Q3W
Part C Imaging Substudy: 89Zr-TAK-164 and TAK-164
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count [ANC] less than (<) 500 cells/cubic millimeter [mm^3]), thrombocytopenia (platelets <25,000/mm^3), febrile neutropenia (ANC <1000/mm^3) with fever (greater than [>] 38.3 degree Celsius or sustained temperature of greater than or equal to (>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (<1 week) Grade 3 fatigue.
Baseline up to Month 22
Percentage of Participants With Adverse Events (AEs)
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Percentage of Participants With Grade 3 or Above AEs
AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition.
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Percentage of Participants With Drug-related AEs
Secondary Outcomes
Measure
Description
Time Frame
Cmax: Maximum Observed Plasma Concentration for TAK-164
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed measurable advanced and/or metastatic solid GI tumor that expresses GCC protein (H-score greater than or equal to [>=] 10), for which standard treatment is no longer effective or does not offer curative or life-prolonging benefit. For the escalation part of the study (Part A), GI malignancies include, but are not limited to, metastatic colorectal carcinoma (mCRC), gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic cancer. The expansion part of the study (Part B) is limited to participants with CRC expressing a high-level of GCC (H-Score >=150) and gastric carcinoma (H-Score >=10). Part C includes participants with CRC and gastric carcinoma (H-score >=10 for both indications).
o Part B of the study will be limited to participants with 2 or 3 prior lines of systemic standard of care therapy.
Male or female participants 18 years or older.
Adequate bone marrow function, defined as an absolute neutrophil count (ANC) of >=1.5*10^9 per liter (/L), platelet count >=100*10^9/L, and hemoglobin >=9 gram per deciliter (g/dL). Receiving transfusions or hematopoietic growth factors to meet enrollment criteria is not allowed within 14 days preceding the first dose of study drug.
Adequate hepatic function with total bilirubin less than or equal to (<=) 1.5* upper limit of normal (ULN), serum ALT and AST must be less than (<) 2.5*ULN (AST and ALT may be elevated up to 3*ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver), serum albumin > 3.0 g/dL.
Adequate renal function as defined by creatinine CL >= 60 milliliter per minute (mL/min).
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
Life expectancy of at least 12 weeks.
Completion of prior chemotherapy, biologic therapy, immunotherapy, or radiation therapy at least 4 weeks prior to enrollment.
Resolution of all toxic effects of prior treatments (except alopecia) to Grade <=1 NCI CTCAE, version 5.
A portion of participants should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamic assessment.
Additionally for Part C (imaging sub study), participant must fulfill the following criteria:
At least 1 extrahepatic metastatic lesion >=2 centimeter (cm) in the longest diameter.
Exclusion Criteria:
Treatment with anticancer chemotherapy or biologic therapy or with an experimental anticancer agent within 28 days of the initial dose of study drug.
Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in TAK-164 formulation or 89Zr-TAK-164 formulation.
Use of strong cytochrome P3A (CYP3A) inhibitors and CYP3A inducers or inhibitors or modulators of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 1 week before the first dose of study drug.
For participants enrolled in studies in which tumor biopsies are obtained:
Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate the tumor biopsy procedure.
Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, heparin, or warfarin).
Participant has concurrent alcohol abuse or a history of drug-induced liver injury (DILI).
Kim R, Leal AD, Parikh A, Ryan DP, Wang S, Bahamon B, Gupta N, Moss A, Pye J, Miao H, Inguilizian H, Cleary JM. A phase I, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C. Cancer Chemother Pharmacol. 2023 Apr;91(4):291-300. doi: 10.1007/s00280-023-04507-w. Epub 2023 Feb 4.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with advanced gastrointestinal (GI) cancers expressing guanylyl cyclase C (GCC) were enrolled in this study to receive TAK-164, every 3 weeks in Part A (Dose Escalation) of the study. Study was terminated after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.
Recruitment Details
Participants took part in the study at 5 investigative sites in the United States from 23 April 2018 to 27 February 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 milligram per kilogram (mg/kg), intravenous infusion, on Day 1 of each 21-day treatment cycle until progressive disease (PD), unacceptable toxicity or discontinuation by participant.
FG001
Part A: TAK-164 0.008 mg/kg
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
0
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
Sep 4, 2019
Feb 24, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
89Zr-TAK-164
Drug
89Zr-TAK-164 intravenous infusion
Part C Imaging Substudy: 89Zr-TAK-164 and TAK-164
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Percentage of Participants With Drug-related Grade 3 or Above AEs
AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition.
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Percentage of Participants With Serious Adverse Events (SAEs)
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Percentage of Participants With AEs Leading to Discontinuation
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Recommended Phase 2 Dose (RP2D) of TAK-164
RP2D was the highest safe dose that could be applied to the expansion phase.
Baseline up to Month 22
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAK-164
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Overall Response Rate (ORR)
ORR was assessed by the investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR or stable disease (SD). DCR was assessed based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Baseline up to Month 22
Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters. PD was >=20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD.
From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
Progression-free Survival (PFS)
PFS was defined as the time from date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first according to modified RECIST version 1.1 criteria. PD was >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. PFS was censored at the last response assessment that is stable disease or better, prior to receipt of subsequent anticancer therapy, if applicable. Participants with no post-baseline assessments was censored at Day 1.
From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum
Abu-Yousif AO, Cvet D, Gallery M, Bannerman BM, Ganno ML, Smith MD, Lai KC, Keating TA, Stringer B, Kamali A, Eng K, Koseoglu S, Zhu A, Xia CQ, Landen MS, Borland M, Robertson R, Bolleddula J, Qian MG, Fretland J, Veiby OP. Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-derived Xenografts. Mol Cancer Ther. 2020 Oct;19(10):2079-2088. doi: 10.1158/1535-7163.MCT-19-1102. Epub 2020 Aug 11.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG004
Part A: TAK-164 0.064 mg/kg
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG005
Part A: TAK-164 0.12 mg/kg
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG006
Part A: TAK-164 0.16 mg/kg
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG007
Part A: TAK-164 0.19 mg/kg
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG008
Part A: TAK-164 0.25 mg/kg
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG009
Part A: TAK-164 0.32 mg/kg
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0047 subjects
FG0057 subjects
FG0062 subjects
FG0073 subjects
FG0083 subjects
FG0091 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0047 subjects
FG0057 subjects
FG0062 subjects
FG0073 subjects
FG0083 subjects
FG0091 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
Symptomatic Deterioration
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety population was defined as all participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG004
Part A: TAK-164 0.064 mg/kg
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG005
Part A: TAK-164 0.12 mg/kg
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG006
Part A: TAK-164 0.16 mg/kg
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG007
Part A: TAK-164 0.19 mg/kg
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG008
Part A: TAK-164 0.25 mg/kg
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG009
Part A: TAK-164 0.32 mg/kg
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0021
BG0035
BG0047
BG0057
BG0062
BG0073
BG0083
BG0091
BG01031
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.0± NAStandard deviation could not be calculated because only one participant was evaluable.
BG00152.0± NAStandard deviation could not be calculated because only one participant was evaluable.
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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
BG0001
BG0011
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
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count [ANC] less than (<) 500 cells/cubic millimeter [mm^3]), thrombocytopenia (platelets <25,000/mm^3), febrile neutropenia (ANC <1000/mm^3) with fever (greater than [>] 38.3 degree Celsius or sustained temperature of greater than or equal to (>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (<1 week) Grade 3 fatigue.
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline up to Month 22
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG004
Part A: TAK-164 0.064 mg/kg
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG005
Part A: TAK-164 0.12 mg/kg
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG006
Part A: TAK-164 0.16 mg/kg
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG007
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percentage of Participants With Adverse Events (AEs)
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Primary
Percentage of Participants With Grade 3 or Above AEs
AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition.
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Primary
Percentage of Participants With Drug-related AEs
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Primary
Percentage of Participants With Drug-related Grade 3 or Above AEs
AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition.
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Primary
Percentage of Participants With Serious Adverse Events (SAEs)
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Primary
Percentage of Participants With AEs Leading to Discontinuation
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-164
Pharmacokinetic (PK) analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Posted
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
Secondary
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Posted
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
Secondary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Posted
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
Secondary
Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAK-164
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Posted
Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
Secondary
Overall Response Rate (ORR)
ORR was assessed by the investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment.
Posted
Number
95% Confidence Interval
percentage of participants
From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Secondary
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR or stable disease (SD). DCR was assessed based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-Baseline disease assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to Month 22
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Secondary
Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters. PD was >=20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD.
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events CR or PR.
Posted
Median
95% Confidence Interval
months
From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first according to modified RECIST version 1.1 criteria. PD was >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. PFS was censored at the last response assessment that is stable disease or better, prior to receipt of subsequent anticancer therapy, if applicable. Participants with no post-baseline assessments was censored at Day 1.
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events (PD or/and death).
Posted
Median
95% Confidence Interval
months
From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
Secondary
Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum
The immunogenicity evaluable population was defined as all participants with a baseline immunogenicity assessment and at least 1 postbaseline immunogenicity assessment.
Posted
Count of Participants
Participants
Baseline up to Month 22
ID
Title
Description
OG000
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
OG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Primary
Recommended Phase 2 Dose (RP2D) of TAK-164
RP2D was the highest safe dose that could be applied to the expansion phase.
The safety population was defined as all participants who received at least 1 dose of study drug.
Posted
Number
mg/kg
Baseline up to Month 22
ID
Title
Description
OG000
Part A: TAK-164
TAK-164 0.004, 0.008, 0.016, 0.032, 0.064, 0.12, 0.16, 0.19, 0.25 or 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Units
Counts
Participants
OG000
Time Frame
Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Description
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
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
Part A: TAK-164 0.004 mg/kg
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
1
0
1
1
1
EG001
Part A: TAK-164 0.008 mg/kg
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
1
1
1
1
1
EG002
Part A: TAK-164 0.016 mg/kg
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
1
0
1
1
1
EG003
Part A: TAK-164 0.032 mg/kg
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
5
3
5
5
5
EG004
Part A: TAK-164 0.064 mg/kg
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
1
7
0
7
7
7
EG005
Part A: TAK-164 0.12 mg/kg
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
7
3
7
6
7
EG006
Part A: TAK-164 0.16 mg/kg
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
2
1
2
2
2
EG007
Part A: TAK-164 0.19 mg/kg
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
1
3
2
3
3
3
EG008
Part A: TAK-164 0.25 mg/kg
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
3
2
3
3
3
EG009
Part A: TAK-164 0.32 mg/kg
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
0
1
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected1 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG0033 events3 affected5 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected3 at risk
EG0082 events1 affected3 at risk
EG0090 events0 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0024 events1 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected1 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal wall mass
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Extravasation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Infusion site haemorrhage
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Injection site bruising
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bladder discomfort
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Candida infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Skin swelling
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 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.