First-in-Human Study of TAK-280 in Participants With Soli... | NCT05220098 | Trialant
NCT05220098
Sponsor
Takeda
Status
Terminated
Last Update Posted
Jul 7, 2026Actual
Enrollment
69Actual
Phase
Phase 1Phase 2
Conditions
Unresectable Locally Advanced or Metastatic Cancer
Interventions
TAK-280
Countries
United States
Australia
Canada
Spain
Protocol Section
Identification Module
NCT ID
NCT05220098
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TAK-280-1501
Secondary IDs
ID
Type
Description
Link
2023-504012-16-00
EU Trial (CTIS) Number
EU CTIS
Brief Title
First-in-Human Study of TAK-280 in Participants With Solid Tumors
Official Title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Terminated due to limited anti-cancer activity
Expanded Access Info
No
Start Date
Apr 21, 2022Actual
Primary Completion Date
Jul 28, 2025Actual
Completion Date
Jul 28, 2025Actual
First Submitted Date
Jan 7, 2022
First Submission Date that Met QC Criteria
Feb 1, 2022
First Posted Date
Feb 2, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Feb 25, 2026
Results First Submitted that Met QC Criteria
Jun 9, 2026
Results First Posted Date
Jul 7, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 9, 2026
Last Update Posted Date
Jul 7, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Name
Class
Takeda Development Center Americas, Inc.
INDUSTRY
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies.
Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days.
After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.
Detailed Description
This study consists of 2 phases: Dose-escalation and cohort-expansion phase.
Dose-escalation phase:
The purpose of the dose-escalation phase is to generate data to characterize the initial safety and tolerability profile of TAK-280 and determine the 2 recommended doses for expansion (RDEs) of TAK-280 to be administered during the cohort-expansion phase.
Cohort-Expansion Phase:
The cohort expansion phase will be conducted in 3 indications. Only in 1 selected indication participants will be randomized 1:1 to receive either TAK-280 high dose or low dose. In the remaining 2 indications to be studied in the cohort-expansion phase, participants will receive only one dose level of TAK-280.
Conditions Module
Conditions
Unresectable Locally Advanced or Metastatic Cancer
Keywords
Not provided
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose-escalation Phase: TAK-280
Experimental
Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Drug: TAK-280
Cohort-expansion Phase: TAK-280 High or low Dose
Experimental
Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Drug: TAK-280
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-280
Drug
Participants will receive TAK-280 as IV infusion.
Cohort-expansion Phase: TAK-280 High or low Dose
Dose-escalation Phase: TAK-280
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 5.0, except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.
Cycle 1 (Cycle length=28 days)
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE was defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of new anticancer therapy. AEs were evaluated according to NCI CTCAE, Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.
From start of study drug administration up to follow-up (up to 37 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of TAK-280
Cmax for TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) of TAK- 280
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable.
Criteria for disease state in dose escalation and cohort expansion.
Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.
Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1.
Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was >=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.
Exclusion Criteria
History of known autoimmune disease.
Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.
Unhealed wounds from surgery or injury.
Ongoing or active infection of Grade >=2.
Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
Inflammatory process that has not resolved for >= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.
Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
Known hypersensitivity to TAK-280 or any excipient.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Study Director
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Arkansas For Medical Sciences
Little Rock
Arkansas
72205
United States
University of California San Francisco
References Module
Citations
Not provided
See Also Links
Label
URL
Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
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.
A total of 69 participants were enrolled and received study treatment in the dose-escalation phase. The study was terminated early by the sponsor due to the limited anti-cancer activity observed with TAK-280 during dose-escalation phase. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels A to J. The study ended early, so only dose-escalation phase was conducted.
Recruitment Details
Participants took part in 20 investigative sites in the United States, Australia, Canada, and Spain from 21 April 2022 to 28 July 2025.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
FG001
TAK-280, Dose B
Periods
Title
Milestones
Reasons Not Completed
Period 1: TAK-280 Dose Level A (Lowest)
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
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
Feb 22, 2024
Jun 9, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose-escalation Phase is non-randomized and Cohort-expansion Phase will include randomized and non-randomized cohorts.
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
AUC0-last for TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of TAK-280
AUC0-inf for TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of TAK-280
Tmax for TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
T1/2 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Total Clearance (CL) of TAK-280
CL of TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280
Vss of TAK-280 was reported.
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
Overall Response Rate (ORR)
ORR was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) as defined by the Investigator based on radiologic criteria. ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 37 weeks
Duration of Response (DOR)
The DOR was assessed according to RECIST version 1.1. and defined as time from the date of first documentation of a PR or better to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurred first, for participants with a confirmed response (PR or better). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 37 weeks
Progression Free Survival (PFS)
PFS was assessed according to RECIST version 1.1 and was defined as the time from the date of first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.
Up to 37 weeks
Overall Survival (OS)
OS was defined as the time from the date of first dose TAK-280 until death due to any cause.
Up to 37 weeks
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved PR, CR, or stable disease (SD) with a duration of >=2 consecutive scans determined by the investigator as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Up to 37 weeks
Number of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
PSA response was defined as a reduction in baseline PSA level of greater than or equal to (>=) 50% maintained for at least 3 weeks in participants with mCRPC.
Up to 37 weeks
Duration of PSA Response in Participants With mCRPC
Duration of PSA response was the time from the date of the first PSA response to the date of the first documented PSA progression in participants with mCRPC.
Up to 37 weeks
Time to PSA Progression in Participants With mCRPC
Time to PSA progression was the time from the date of the first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir in participants with mCRPC.
Up to 37 weeks
Percentage of Participants With PSA Reductions of >=50% at 6 Months
PSA response was defined as a reduction in baseline PSA level of >=50% maintained for at 6 months in participants with mCRPC.
At 6 months
Number of Participants Who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
Number of participants who were negative for TAK-280 at baseline and became positive were reported.
Up to 37 weeks
Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280
Number of participants who developed B7-H3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Up to 37 weeks
Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280
Number of participants who developed CD3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
FG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
FG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
FG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
FG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
FG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
FG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
FG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
FG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Period 2: TAK-280 Dose Level B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Period 3: TAK-280 Dose Level C
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Period 4: TAK-280 Dose Level D
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 5: TAK-280 Dose Level E
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 6: TAK-280 Dose Level F
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 7: TAK-280 Dose Level G
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 8: TAK-280 Dose Level H
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00712 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 9: TAK-280 Dose Level I
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00826 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 10:TAK-280 Dose Level J (Highest)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
BG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
BG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
BG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
BG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
BG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
BG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
BG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
BG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
BG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0011
BG0023
BG0035
BG0045
BG0055
BG0068
BG00712
BG00826
BG0092
BG01069
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
BG00064.0± 7.07
BG00161.0± NAStandard deviation could not be estimated for single participant.
BG00268.0± 10.54
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
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
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 5.0, except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.
The DLT-evaluable analysis set included all participants in the dose-escalation phase who had received at least 3 doses of TAK-280 or had a DLT within the DLT-evaluation period. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Cycle 1 (Cycle length=28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE was defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of new anticancer therapy. AEs were evaluated according to NCI CTCAE, Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Posted
Count of Participants
Participants
From start of study drug administration up to follow-up (up to 37 weeks)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
Secondary
Maximum Observed Plasma Concentration (Cmax) of TAK-280
Cmax for TAK-280 was reported.
The pharmacokinetics (PK) analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) of TAK- 280
AUC0-last for TAK-280 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanogram per milliliter(h*ng/mL)
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of TAK-280
AUC0-inf for TAK-280 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of TAK-280
Tmax for TAK-280 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
hours
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
T1/2 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
hours
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Total Clearance (CL) of TAK-280
CL of TAK-280 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour per kilogram (L/h/kg)
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280
Vss of TAK-280 was reported.
The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per kilogram (L/kg)
Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Overall Response Rate (ORR)
ORR was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) as defined by the Investigator based on radiologic criteria. ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
Secondary
Duration of Response (DOR)
The DOR was assessed according to RECIST version 1.1. and defined as time from the date of first documentation of a PR or better to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurred first, for participants with a confirmed response (PR or better). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280. Here, "Overall number of participants analyzed" signifies participants who had a OR.
Posted
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
Secondary
Progression Free Survival (PFS)
PFS was assessed according to RECIST version 1.1 and was defined as the time from the date of first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Posted
Median
Full Range
weeks
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Overall Survival (OS)
OS was defined as the time from the date of first dose TAK-280 until death due to any cause.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Posted
Median
95% Confidence Interval
weeks
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
Secondary
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved PR, CR, or stable disease (SD) with a duration of >=2 consecutive scans determined by the investigator as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
Secondary
Number of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
PSA response was defined as a reduction in baseline PSA level of greater than or equal to (>=) 50% maintained for at least 3 weeks in participants with mCRPC.
PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
Posted
Count of Participants
Participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280: Participants With mCRPC
Participants with mCRPC who received TAK-280 Dose A to Dose J, IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Units
Counts
Participants
OG000
Secondary
Duration of PSA Response in Participants With mCRPC
Duration of PSA response was the time from the date of the first PSA response to the date of the first documented PSA progression in participants with mCRPC.
PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected.
Posted
Up to 37 weeks
ID
Title
Description
OG000
TAK-280: Participants With mCRPC
Participants with mCRPC who received TAK-280 Dose A to Dose J, IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Units
Counts
Participants
OG000
Secondary
Time to PSA Progression in Participants With mCRPC
Time to PSA progression was the time from the date of the first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir in participants with mCRPC.
PSA response analysis set was used. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
Posted
Median
Full Range
weeks
Up to 37 weeks
ID
Title
Description
OG000
TAK-280: Participants With mCRPC
Participants with mCRPC who received TAK-280 Dose A to Dose J, IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With PSA Reductions of >=50% at 6 Months
PSA response was defined as a reduction in baseline PSA level of >=50% maintained for at 6 months in participants with mCRPC.
PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
Posted
Number
95% Confidence Interval
percentage of participants
At 6 months
ID
Title
Description
OG000
TAK-280: Participants With mCRPC
Participants with mCRPC who received TAK-280 Dose A to Dose J, IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Units
Counts
Participants
OG000
Secondary
Number of Participants Who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
Number of participants who were negative for TAK-280 at baseline and became positive were reported.
Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
Secondary
Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280
Number of participants who developed B7-H3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here "overall number of participants analyzed" signifies participants who developed positive induced ADA to TAK-280 and gave consent to participate in the assessment for this outcome.
Posted
Count of Participants
Participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Secondary
Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280
Number of participants who developed CD3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here "overall number of participants analyzed" signifies participants who developed positive induced ADA to TAK-280 and gave consent to participate in the assessment for this outcome.
Posted
Count of Participants
Participants
Up to 37 weeks
ID
Title
Description
OG000
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
OG001
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
OG002
TAK-280, Dose C
Time Frame
From start of study drug administration up to follow-up (up to 37 weeks)
Description
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
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
TAK-280 Dose A
Participants received TAK-280, Dose A IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
1
2
2
2
2
2
EG001
TAK-280 Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
1
1
0
1
1
1
EG002
TAK-280 Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
1
3
1
3
3
3
EG003
TAK-280 Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
3
5
4
5
5
5
EG004
TAK-280 Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
3
5
4
5
5
5
EG005
TAK-280 Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
5
5
4
5
5
5
EG006
TAK-280 Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
7
8
6
8
8
8
EG007
TAK-280 Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
6
12
8
12
12
12
EG008
TAK-280 Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
5
26
14
26
26
26
EG009
TAK-280 Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
1
2
2
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG0032 affected5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected8 at risk
EG0071 affected12 at risk
EG0082 affected26 at risk
EG0091 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion site thrombosis
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Thoracic radiculopathy
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG0030 affected5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected8 at risk
EG0071 affected12 at risk
EG0080 affected26 at risk
EG0090 affected2 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time shortened
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood iron decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bradyphrenia
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bronchostenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Catheter site erythema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Epstein-Barr virus infection reactivation
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Haemoglobinuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0021 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Immature granulocyte count increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Infusion site rash
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Injection site reaction
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lip infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Liver function test increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Metastases to vagina
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oesophageal compression
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pallor
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Protein total decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0021 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Specific gravity urine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urine output increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vitamin B1 deficiency
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
The study was terminated early by the sponsor due to the limited anti-cancer activity observed with TAK-280 during dose-escalation phase.
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0044
OG0052
OG0066
OG00711
OG00818
OG0092
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA means data could not be calculated because concentration was below limit of quantification (BLQ).
OG001NA± NANA means data could not be calculated because concentration was BLQ.
OG0023.74± 27.0
OG00316.8± 39.4
OG0048.91± 13.7
OG005NA± NANA means data could not be calculated because concentration was BLQ.
OG00612.2± 40.8
OG00718.4± 107.0
OG00821.2± 95.3
OG009NA± NANA means data could not be calculated because concentration was BLQ.
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0043
OG0052
OG0066
OG00711
OG00818
OG0092
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA means data could not be calculated because concentration was BLQ.
OG001NA± NANA means data could not be calculated because concentration was BLQ.
OG00226.4± 96.1
OG003270± 39.8
OG004106± 46.7
OG005NA± NANA means data could not be calculated because concentration was BLQ.
OG006166± 45.9
OG007235± 61.1
OG008318± 40.5
OG009NA± NANA means data could not be calculated because concentration was BLQ.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0032
OG0041
OG0052
OG0066
OG0075
OG0088
OG0091
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA means data could not be calculated because concentration was BLQ.
OG001NA± NANA means data could not be calculated because concentration was BLQ.
OG002NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter
OG003NA± NANA means data could not be calculated because concentration was BLQ.
OG004NA± NANA means data could not be calculated because concentration was BLQ.
OG005NA± NANA means data could not be calculated because concentration was BLQ.
OG006NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter
OG007268± 65.0
OG008420± 58.7
OG009NA± NANA means data could not be calculated because concentration was BLQ
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0044
OG0052
OG0066
OG00711
OG00818
OG0092
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA means data could not be calculated because concentration was BLQ.
OG001NA(NA to NA)NA means data could not be calculated because concentration was BLQ.
OG0021.02(1.02 to 1.12)
OG0031.10(1.07 to 1.17)
OG0041.01(1.00 to 1.73)
OG0051.15(1.12 to 1.17)
OG0061.09(1.02 to 1.15)
OG0071.10(1.03 to 1.20)
OG0081.22(1.00 to 6.17)
OG0091.08(1.07 to 1.08)
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0043
OG0052
OG0066
OG00711
OG00817
OG0092
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA means data could not be calculated because concentration was BLQ.
OG001NA(NA to NA)NA means data could not be calculated because concentration was BLQ.
OG002NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG003NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG004NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG005NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG006NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG007NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG008NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG009NA(NA to NA)Median and full range was not calculable due to insufficient number of valid PK sampling.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0032
OG0041
OG0052
OG0066
OG0075
OG0088
OG0091
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA means data could not be calculated because concentration was BLQ.
OG001NA± NANA means data could not be calculated because concentration was BLQ.
OG002NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
OG003NA± NANA means data could not be calculated because concentration was BLQ.
OG004NA± NANA means data could not be calculated because concentration was BLQ.
OG005NA± NANA means data could not be calculated because concentration was BLQ.
OG006NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
OG0070.0168± 65.0
OG0080.0143± 58.7
OG009NA± NANA means data could not be calculated because concentration was BLQ.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0032
OG0041
OG0052
OG0066
OG0075
OG0088
OG0091
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA means data could not be calculated because concentration was BLQ.
OG001NA± NANA means data could not be calculated because concentration was BLQ.
OG002NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
OG003NA± NANA means data could not be calculated because concentration was BLQ.
OG004NA± NANA means data could not be calculated because concentration was BLQ.
OG005NA± NANA means data could not be calculated because concentration was BLQ.
OG006NA± NANA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
OG0070.344± 52.2
OG0080.273± 45.3
OG009NA± NANA means data could not be calculated because concentration was BLQ.
OG002
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
OG0030(0.0 to 52.2)
OG0040(0.0 to 52.2)
OG0050.0(0.0 to 52.2)
OG0060(0.0 to 36.9)
OG0070(0.0 to 26.5)
OG0080(0.0 to 13.2)
OG0090(0.0 to 84.2)
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG00013.7(4.0 to 23.4)
OG0016.3(6.3 to 6.3)
OG0028.4(6.4 to 23.3)
OG0039.6(4.1 to 20.0)
OG0045.4(4.3 to 57.0)
OG0057.0(0.1 to 15.6)
OG0068.1(0.1 to 15.9)
OG0077.4(0.1 to 19.0)
OG0089.0(0.1 to 32.1)
OG0097.7(4.3 to 7.7)
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG000NA(9.7 to NA)Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG00121.9(NA to NA)Lower and upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG002NA(7.0 to NA)Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG00311.9(9.6 to NA)Upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG00438.7(5.4 to NA)Upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG00524.3(6.6 to NA)Upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG00636.7(10.3 to 39.7)
OG00732.3(6.0 to NA)Upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG008NA(25.1 to NA)Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
OG009NA(11.4 to NA)Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0068
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
OG00320.0(0.5 to 71.6)
OG00440.0(5.3 to 85.3)
OG00520.0(0.5 to 71.6)
OG00625.0(3.2 to 65.1)
OG00716.7(2.1 to 48.4)
OG00834.6(17.2 to 55.7)
OG0090(0.0 to 84.2)
8
Title
Denominators
Categories
Title
Measurements
OG0000
0
6
Title
Denominators
Categories
Title
Measurements
OG0008.1(3.1 to 16.0)
8
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 36.9)
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG0035
OG0045
OG0055
OG0067
OG00712
OG00826
OG0092
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0032
OG0044
OG0054
OG0066
OG0079
OG00822
OG0092
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0044
OG0054
OG0066
OG0079
OG00819
OG0092
Title
Denominators
Categories
Title
Measurements
Participants positive for B7-H3 NAb
OG0000
OG0010
OG0021
OG0032
OG0044
OG0052
OG0062
OG0075
OG00811
OG0092
Participants negative for B7 -H3 NAb
OG0000
OG0010
OG0021
OG0030
OG004
Unknown participants for B7-H3 Nab
OG0000
OG0010
OG0020
OG0030
OG004
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
OG003
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
OG004
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
OG005
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
OG006
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
OG007
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
OG008
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
OG009
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.