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A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)

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ClinicalTrials.gov Identifier: NCT03449030
Recruitment Status : Terminated (Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.)
First Posted : February 28, 2018
Results First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
Interventions Drug: TAK-164
Drug: 89Zr-TAK-164
Enrollment 31
Recruitment Details Participants took part in the study at 5 investigative sites in the United States from 23 April 2018 to 27 February 2020.
Pre-assignment Details Participants with advanced gastrointestinal (GI) cancers expressing guanylyl cyclase C (GCC) were enrolled in this study to receive TAK-164, every 3 weeks in Part A (Dose Escalation) of the study. Study was terminated after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description TAK-164 0.004 milligram per kilogram (mg/kg), intravenous infusion, on Day 1 of each 21-day treatment cycle until progressive disease (PD), unacceptable toxicity or discontinuation by participant. TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Period Title: Overall Study
Started 1 1 1 5 7 7 2 3 3 1
Completed 0 0 0 0 0 0 0 0 0 0
Not Completed 1 1 1 5 7 7 2 3 3 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1             1             1             1             2             0             0
Symptomatic Deterioration             0             1             0             0             0             1             1             0             2             0
Progressive Disease             1             0             1             4             5             3             0             1             1             1
Adverse Event             0             0             0             0             0             2             0             0             0             0
Death             0             0             0             0             1             0             0             0             0             0
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg Total
Hide Arm/Group Description TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 5 7 7 2 3 3 1 31
Hide Baseline Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 5 participants 7 participants 7 participants 2 participants 3 participants 3 participants 1 participants 31 participants
72.0 [1]   (NA) 52.0 [1]   (NA) 59.0 [1]   (NA) 55.2  (8.14) 57.1  (8.36) 48.0  (13.11) 53.0  (14.14) 65.3  (3.21) 48.0  (3.61) 39.0 [1]   (NA) 54.2  (10.59)
[1]
Standard deviation could not be calculated because only one participant was evaluable.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 5 participants 7 participants 7 participants 2 participants 3 participants 3 participants 1 participants 31 participants
Female
1
 100.0%
1
 100.0%
1
 100.0%
4
  80.0%
4
  57.1%
4
  57.1%
1
  50.0%
1
  33.3%
0
   0.0%
1
 100.0%
18
  58.1%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
3
  42.9%
3
  42.9%
1
  50.0%
2
  66.7%
3
 100.0%
0
   0.0%
13
  41.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 5 participants 7 participants 7 participants 2 participants 3 participants 3 participants 1 participants 31 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
1
 100.0%
4
  80.0%
6
  85.7%
7
 100.0%
2
 100.0%
3
 100.0%
3
 100.0%
1
 100.0%
29
  93.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 5 participants 7 participants 7 participants 2 participants 3 participants 3 participants 1 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  33.3%
0
   0.0%
1
 100.0%
3
   9.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
White
1
 100.0%
1
 100.0%
1
 100.0%
4
  80.0%
6
  85.7%
5
  71.4%
2
 100.0%
2
  66.7%
3
 100.0%
0
   0.0%
25
  80.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 1 participants 5 participants 7 participants 7 participants 2 participants 3 participants 3 participants 1 participants 31 participants
1
 100.0%
1
 100.0%
1
 100.0%
5
 100.0%
7
 100.0%
7
 100.0%
2
 100.0%
3
 100.0%
3
 100.0%
1
 100.0%
31
 100.0%
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count [ANC] less than (<) 500 cells/cubic millimeter [mm^3]), thrombocytopenia (platelets <25,000/mm^3), febrile neutropenia (ANC <1000/mm^3) with fever (greater than [>] 38.3 degree Celsius or sustained temperature of greater than or equal to (>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (<1 week) Grade 3 fatigue.
Time Frame Baseline up to Month 22
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
2
  66.7%
0
   0.0%
2.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100 100 100 100 100 100 100
3.Primary Outcome
Title Percentage of Participants With Grade 3 or Above AEs
Hide Description AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition.
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
0 100 100 60 14.3 71.4 50.0 100 100 0
4.Primary Outcome
Title Percentage of Participants With Drug-related AEs
Hide Description [Not Specified]
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
100 0 100 100 85.7 71.4 50.0 66.7 66.7 100
5.Primary Outcome
Title Percentage of Participants With Drug-related Grade 3 or Above AEs
Hide Description AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition.
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
0 0 100 20.0 14.3 42.9 50.0 33.3 66.7 0
6.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
0 100 0 60 0 42.9 50.0 66.7 66.7 0
7.Primary Outcome
Title Percentage of Participants With AEs Leading to Discontinuation
Hide Description [Not Specified]
Time Frame From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 7 2 3 3 1
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0 28.6 0 0 33.3 0
8.Primary Outcome
Title Recommended Phase 2 Dose (RP2D) of TAK-164
Hide Description RP2D was the highest safe dose that could be applied to the expansion phase.
Time Frame Baseline up to Month 22
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Part A: TAK-164
Hide Arm/Group Description:
TAK-164 0.004, 0.008, 0.016, 0.032, 0.064, 0.12, 0.16, 0.19, 0.25 or 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: mg/kg
0.064
9.Secondary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-164
Hide Description [Not Specified]
Time Frame Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164
Hide Description [Not Specified]
Time Frame Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164
Hide Description [Not Specified]
Time Frame Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAK-164
Hide Description [Not Specified]
Time Frame Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was assessed by the investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
Time Frame From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22)
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 6 5 2 2 1 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 97.5)
100
(2.5 to 100.0)
0
(0.0 to 97.5)
0
(0.0 to 52.2)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 84.2)
0
(0.0 to 84.2)
0
(0.0 to 97.5)
0
(0.0 to 97.5)
14.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of participants with CR, PR or stable disease (SD). DCR was assessed based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Time Frame Baseline up to Month 22
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-Baseline disease assessment.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 6 5 2 2 1 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(2.5 to 100.0)
100
(2.5 to 100.0)
100
(2.5 to 100.0)
40.0
(5.3 to 85.3)
50.0
(11.8 to 88.2)
40.0
(5.3 to 85.3)
50.0
(1.3 to 98.7)
50.0
(1.3 to 98.7)
0
(0.0 to 97.5)
0
(0.0 to 97.5)
15.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters. PD was >=20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD.
Time Frame From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events CR or PR.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 0 1 0 0 0 0 0 0 0 0
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median, lower and upper limit of 95% CI could not be calculated because none of the participant had an event (PD or death)
16.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first according to modified RECIST version 1.1 criteria. PD was >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. PFS was censored at the last response assessment that is stable disease or better, prior to receipt of subsequent anticancer therapy, if applicable. Participants with no post-baseline assessments was censored at Day 1.
Time Frame From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events (PD or/and death).
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 0 1 4 6 3 1 2 1 1
Median (95% Confidence Interval)
Unit of Measure: months
2.79 [1] 
(NA to NA)
6.24 [1] 
(NA to NA)
1.35 [2] 
(0.59 to NA)
1.91
(1.22 to 3.48)
1.58
(1.08 to 1.58)
1.41 [1] 
(NA to NA)
1.81
(1.25 to 2.37)
1.05 [1] 
(NA to NA)
1.18 [1] 
(NA to NA)
[1]
Lower and upper limit of 95% CI could not be calculated because only one participant had an event.
[2]
Upper limit of 95% CI could not be calculated because insufficient number of participants had an event.
17.Secondary Outcome
Title Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum
Hide Description [Not Specified]
Time Frame Baseline up to Month 22
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity evaluable population was defined as all participants with a baseline immunogenicity assessment and at least 1 postbaseline immunogenicity assessment.
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description:
TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
Overall Number of Participants Analyzed 1 1 1 5 7 6 2 1 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 30 days following the last dose of study drug (up to 22 months)
Adverse Event Reporting Description At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data for markedly abnormal values for laboratory tests and vital sign are embedded in this AE section.
 
Arm/Group Title Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Hide Arm/Group Description TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant. TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
All-Cause Mortality
Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/5 (0.00%)      1/7 (14.29%)      0/7 (0.00%)      0/2 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      3/5 (60.00%)      0/7 (0.00%)      3/7 (42.86%)      1/2 (50.00%)      2/3 (66.67%)      2/3 (66.67%)      0/1 (0.00%)    
Cardiac disorders                     
Arrhythmia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders                     
Abdominal pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0
Small intestinal obstruction  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  4 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Proctalgia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Vomiting  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders                     
Pyrexia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Hepatobiliary disorders                     
Bile duct obstruction  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hepatic failure  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hyperbilirubinaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                     
Pneumonia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Sepsis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Investigations                     
Blood bilirubin increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Alanine aminotransferase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Platelet count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  1 0/1 (0.00%)  0
Renal and urinary disorders                     
Acute kidney injury  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Pleural effusion  1  0/1 (0.00%)  0 1/1 (100.00%)  2 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: TAK-164 0.004 mg/kg Part A: TAK-164 0.008 mg/kg Part A: TAK-164 0.016 mg/kg Part A: TAK-164 0.032 mg/kg Part A: TAK-164 0.064 mg/kg Part A: TAK-164 0.12 mg/kg Part A: TAK-164 0.16 mg/kg Part A: TAK-164 0.19 mg/kg Part A: TAK-164 0.25 mg/kg Part A: TAK-164 0.32 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      5/5 (100.00%)      7/7 (100.00%)      6/7 (85.71%)      2/2 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 3/5 (60.00%)  3 4/7 (57.14%)  4 3/7 (42.86%)  3 1/2 (50.00%)  2 1/3 (33.33%)  1 2/3 (66.67%)  3 0/1 (0.00%)  0
Lymphopenia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders                     
Atrial fibrillation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Sinus tachycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Tachycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Eye disorders                     
Eye haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders                     
Abdominal pain  1  0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 3/5 (60.00%)  3 2/7 (28.57%)  2 0/7 (0.00%)  0 1/2 (50.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  2 0/1 (0.00%)  0
Nausea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 2/5 (40.00%)  3 2/7 (28.57%)  3 3/7 (42.86%)  3 0/2 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0
Vomiting  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  2 2/5 (40.00%)  3 3/7 (42.86%)  4 1/7 (14.29%)  1 1/2 (50.00%)  2 0/3 (0.00%)  0 2/3 (66.67%)  4 0/1 (0.00%)  0
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 2/7 (28.57%)  2 1/7 (14.29%)  1 1/2 (50.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Abdominal distension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  2 1/7 (14.29%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Diarrhoea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0 1/2 (50.00%)  1 1/3 (33.33%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Dry mouth  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Stomatitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Gastrooesophageal reflux disease  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Abdominal pain lower  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Abdominal wall mass  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Anal haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Colitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dyspepsia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Gingival bleeding  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Lower gastrointestinal haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Proctalgia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders                     
Fatigue  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 4/5 (80.00%)  5 4/7 (57.14%)  5 3/7 (42.86%)  5 0/2 (0.00%)  0 2/3 (66.67%)  2 2/3 (66.67%)  2 0/1 (0.00%)  0
Pyrexia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  2 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  4 0/1 (0.00%)  0
Chills  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Oedema peripheral  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 0/1 (0.00%)  0
Pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Chest pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Extravasation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Influenza like illness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Infusion site haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Injection site bruising  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Mucosal inflammation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Gait disturbance  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hepatobiliary disorders                     
Cholecystitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hyperbilirubinaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                     
Urinary tract infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Candida infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Ear infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Oral candidiasis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pneumonia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Upper respiratory tract infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Injury, poisoning and procedural complications                     
Fall  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Investigations                     
Platelet count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  4 5/5 (100.00%)  6 3/7 (42.86%)  3 5/7 (71.43%)  11 1/2 (50.00%)  1 1/3 (33.33%)  3 3/3 (100.00%)  5 0/1 (0.00%)  0
Aspartate aminotransferase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 3/5 (60.00%)  4 1/7 (14.29%)  1 4/7 (57.14%)  6 0/2 (0.00%)  0 1/3 (33.33%)  1 3/3 (100.00%)  4 0/1 (0.00%)  0
Blood alkaline phosphatase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  2 3/5 (60.00%)  5 0/7 (0.00%)  0 3/7 (42.86%)  3 1/2 (50.00%)  1 1/3 (33.33%)  1 3/3 (100.00%)  3 0/1 (0.00%)  0
Blood bilirubin increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 2/5 (40.00%)  3 0/7 (0.00%)  0 1/7 (14.29%)  1 1/2 (50.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  3 0/1 (0.00%)  0
Alanine aminotransferase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  2 0/7 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0 3/3 (100.00%)  5 0/1 (0.00%)  0
International normalised ratio increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Lymphocyte count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  2 1/7 (14.29%)  2 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Neutrophil count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/5 (40.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 0/1 (0.00%)  0
White blood cell count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/5 (40.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Weight decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  2 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Blood creatinine increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Lipase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                     
Hypokalaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 2/7 (28.57%)  2 1/2 (50.00%)  1 3/3 (100.00%)  3 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypoalbuminaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 3/7 (42.86%)  4 1/2 (50.00%)  2 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hypophosphataemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 3/7 (42.86%)  3 1/2 (50.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Dehydration  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Decreased appetite  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
Hyperglycaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  3 0/1 (0.00%)  0
Hyponatraemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/5 (40.00%)  2 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hyperkalaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypomagnesaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypocalcaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypoglycaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypermagnesaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Back pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  2 2/7 (28.57%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Arthralgia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Flank pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Muscular weakness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pain in extremity  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Cancer pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders                     
Headache  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  2 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dizziness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dysgeusia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Peripheral sensory neuropathy  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Somnolence  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Taste disorder  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders                     
Insomnia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 2/7 (28.57%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Confusional state  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hallucination  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Agitation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Renal and urinary disorders                     
Haematuria  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Proteinuria  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Bladder discomfort  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dysuria  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Hydronephrosis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pollakiuria  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Urinary hesitation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Urinary retention  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Dyspnoea  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  1
Epistaxis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  3 0/1 (0.00%)  0
Cough  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/5 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dysphonia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Oropharyngeal pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Pleural effusion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 0/1 (0.00%)  0
Pleuritic pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Rhinorrhoea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Dyspnoea exertional  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Hiccups  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Productive cough  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Rhinitis allergic  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Decubitus ulcer  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Dermatitis acneiform  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Dermatitis bullous  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Pruritus  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Rash  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin irritation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin lesion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/5 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Skin swelling  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Rash maculo-papular  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders                     
Hypotension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  2 1/5 (20.00%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
Hypertension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  3 0/5 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT03449030    
Other Study ID Numbers: TAK-164-1001
U1111-1207-9923 ( Other Identifier: WHO )
2018-002214-12 ( Registry Identifier: EudraCT )
First Submitted: February 22, 2018
First Posted: February 28, 2018
Results First Submitted: February 24, 2021
Results First Posted: March 22, 2021
Last Update Posted: March 22, 2021