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Clinical Trial Results:
A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

Summary
EudraCT number	2021-006038-37
Trial protocol	NO   DE   FR   IE   ES   GR   IT
Global end of trial date	07 Nov 2024
Results information
Results version number	v1(current)
This version publication date	11 May 2025
First version publication date	11 May 2025
Other versions

Trial information Top of page
Trial identification
Sponsor protocol code	TAK-573-1501
Additional study identifiers
ISRCTN number	-
US NCT number	NCT03215030
WHO universal trial number (UTN)	U1111-1195-8134
Sponsors
Sponsor organisation name	Takeda
Sponsor organisation address	95 Hayden Ave, Lexington, MA, United States, 02421
Public contact	Study Director, Takeda, TrialDisclosures@takeda.com
Scientific contact	Study Director, Takeda, TrialDisclosures@takeda.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	07 Nov 2024
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	07 Nov 2024
Was the trial ended prematurely?	Yes
General information about the trial
Main objective of the trial	The main aim of this study was to evaluate the safety and tolerability, efficacy, pharmacokinetics, and immunogenicity of modakafusp alfa in participants with relapsed refractory multiple myeloma (RRMM).
Protection of trial subjects	Each participant signed an informed consent form (ICF) before participating in the study.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	04 Oct 2017
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Canada: 11
Country: Number of subjects enrolled	Puerto Rico: 1
Country: Number of subjects enrolled	France: 17
Country: Number of subjects enrolled	Greece: 8
Country: Number of subjects enrolled	Italy: 4
Country: Number of subjects enrolled	Japan: 5
Country: Number of subjects enrolled	Norway: 6
Country: Number of subjects enrolled	Spain: 5
Country: Number of subjects enrolled	China: 11
Country: Number of subjects enrolled	Korea, Republic of: 3
Country: Number of subjects enrolled	Türkiye: 4
Country: Number of subjects enrolled	Israel: 10
Country: Number of subjects enrolled	Ireland: 10
Country: Number of subjects enrolled	United States: 173
Worldwide total number of subjects	268
EEA total number of subjects	50
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	111
From 65 to 84 years	156
85 years and over	1

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Participants took part in the study at various investigative sites globally from 4 October 2017 to 7 November 2024.
Pre-assignment
Screening details	Participants with diagnosis of RRMM were enrolled in this study consisting of Part 1 (Dose Escalation), Part 2 (Dose Expansion), Part 3 (Dose Extension), & Japan Safety Lead-in to receive modakafusp alfa with/without dexamethasone. 4 participants enrolled in study but discontinued without receiving TAK-573 dosing and are thus not presented below.
Period 1
Period 1 title	Part 1: Dose Escalation
Is this the baseline period?	Yes
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Part 1 (Dose Escalation) Schedule A
Arm description	Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Intravenous use, Infusion
Dosage and administration details	Modakafusp alfa 0.001 up to 14 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Arm title	Part 1 (Dose Escalation) Schedule B
Arm description	Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Intravenous use, Infusion
Dosage and administration details	Modakafusp alfa 0.20 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Arm title	Part 1 (Dose Escalation) Schedule C
Arm description	Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm title	Part 1 (Dose Escalation) Schedule D
Arm description	Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 1.5 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Number of subjects in period 1 [1] Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Started 20 8 7 21 Completed 2 1 1 7 Not completed 18 7 6 14      Adverse event, serious fatal 15 6 6 8      Consent withdrawn by subject 2 - - 2      Reason Not Specified - - - 3      Lost to follow-up 1 1 - 1
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Only Part 1: Dose Escalation was considered as the baseline reporting period. The groups for the other periods are presented as subject analysis sets.
Period 2
Period 2 title	Part 2: Dose Expansion
Is this the baseline period?	No
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	No
Arm title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Arm description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm title	Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Arm description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Dexamethasone
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	Dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Arm title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Arm description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 1.5 mg/kg, infusion, IV, Q4W on Days 1 of each 28-day treatment cycle until treatment discontinuation.
Arm title	Part 2: Schedule D: Modakafusp Alfa+Dexamethasone
Arm description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Dexamethasone
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	Dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 1.5 mg/kg infusion, IV, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Number of subjects in period 2 Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Started 8 3 25 25 Completed 4 1 11 16 Not completed 4 2 14 9      Adverse event, serious fatal 3 1 5 4      Consent withdrawn by subject 1 1 5 2      Reason Not Specified - - 4 2      Study Terminated by Sponsor - - - 1
Period 3
Period 3 title	Part 3: Dose Extension
Is this the baseline period?	No
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	No
Arm title	Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Arm description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm title	Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Arm description	Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Number of subjects in period 3 Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Started 71 75 Completed 5 7 Not completed 66 68      Adverse event, serious fatal 19 20      Consent withdrawn by subject 6 7      Reason Not Specified 3 -      Study Terminated by Sponsor 38 39      Lost to follow-up - 2
Period 4
Period 4 title	Japan Safety Lead-In
Is this the baseline period?	No
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	No
Arm title	Japan Lead-in: Modakafusp Alfa 60 mg
Arm description	Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm title	Japan Lead-in: Modakafusp Alfa 120 mg
Arm description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Arm type	Experimental
Investigational medicinal product name	Modakafusp Alfa
Investigational medicinal product code	TAK-573
Other name
Pharmaceutical forms	Concentrate for solution for infusion
Routes of administration	Infusion , Intravenous use
Dosage and administration details	Modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Number of subjects in period 4 Japan Lead-in: Modakafusp Alfa 60 mg Japan Lead-in: Modakafusp Alfa 120 mg Started 3 2 Completed 0 0 Not completed 3 2      Study Terminated by Sponsor 3 2

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Part 1 (Dose Escalation) Schedule A
Reporting group description	Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule B
Reporting group description	Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule C
Reporting group description	Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule D
Reporting group description	Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Total Number of subjects 20 8 7 21 Age Categorical Units: Subjects Age continuous Units: years     arithmetic mean (standard deviation) 60.3 ( 10.56 ) 61.1 ( 7.00 ) 60.4 ( 10.47 ) 64.7 ( 10.34 ) - Gender categorical Units: Subjects     Female 10 3 2 10 25     Male 10 5 5 11 31 Ethnicity (NIH/OMB) Units: Subjects     Hispanic or Latino 1 0 1 0 2     Not Hispanic or Latino 19 8 6 21 54     Unknown or Not Reported 0 0 0 0 0 Race (NIH/OMB) Units: Subjects     American Indian or Alaska Native 0 0 0 0 0     Asian 0 0 0 1 1     Native Hawaiian or Other Pacific Islander 0 0 0 0 0     Black or African American 0 3 1 5 9     White 20 4 6 14 44     More than one race 0 0 0 0 0     Unknown or Not Reported 0 1 0 1 2
Subject analysis sets
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.2 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.3 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received Modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule C: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received Modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 1.5 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set title	Part1(Dose Escalation)Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: (Dose Expansion) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Arm: Part 2: Schedule D: Modakafusp Alfa+Dexamethasone
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Japan Lead-in: Modakafusp Alfa 60 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Japan Lead-in: Modakafusp Alfa 120 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis sets values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part 1(Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule C: Modakafusp alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg Part1 (Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Part1(Dose Escalation)Schedule A: Modakafusp alfa 0.01 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1(Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2: (Dose Expansion) Schedule D: Modakafusp alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg + Dex 40 mg Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Arm: Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Japan Lead-in: Modakafusp Alfa 60 mg Japan Lead-in: Modakafusp Alfa 120 mg Number of subjects 3 6 3 3 3 6 3 4 4 3 2 3 3 3 6 3 3 4 4 4 2 3 3 3 6 3 3 1 2 1 2 4 3 3 6 3 3 4 4 4 2 6 3 2 3 3 1 2 1 2 4 3 3 2 3 3 1 2 1 2 4 3 3 2 3 3 1 2 1 2 4 3 3 2 3 3 1 2 1 2 4 3 3 7 3 21 6 7 3 21 6 7 3 21 6 3 2 19 6 3 2 19 6 3 2 21 6 3 2 19 6 3 2 21 6 8 3 25 25 71 75 3 2 Age Categorical Units: Subjects Age continuous Units: years     arithmetic mean (standard deviation) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) 61.9 ( 8.63 ) 65.7 ( 12.58 ) 64.1 ( 12.17 ) 70.2 ( 7.77 ) 66.2 ( 9.76 ) 66.5 ( 9.61 ) 66.66 ( 9.71 ) 66.00 ( 11.31 ) Gender categorical Units: Subjects     Female 1 2 12 10 34 39 2 0     Male 7 1 13 15 37 36 1 2 Ethnicity (NIH/OMB) Units: Subjects     Hispanic or Latino 0 0 0 1 4 3 0 0     Not Hispanic or Latino 8 3 24 23 51 57 3 2     Unknown or Not Reported 0 0 1 1 16 15 0 0 Race (NIH/OMB) Units: Subjects     American Indian or Alaska Native 0 0 0 0 0 0 0 0     Asian 1 0 2 0 5 9 3 2     Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0     Black or African American 1 0 2 8 10 4 0 0     White 6 3 20 17 38 51 0 0     More than one race 0 0 0 0 0 0 0 0     Unknown or Not Reported 0 0 1 0 18 11 0 0

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Part 1 (Dose Escalation) Schedule A
Reporting group description	Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule B
Reporting group description	Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule C
Reporting group description	Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule D
Reporting group description	Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Reporting group description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Reporting group description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Reporting group description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2: Schedule D: Modakafusp Alfa+Dexamethasone
Reporting group description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Reporting group description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Reporting group description	Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Japan Lead-in: Modakafusp Alfa 60 mg
Reporting group description	Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Japan Lead-in: Modakafusp Alfa 120 mg
Reporting group description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.2 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.3 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received Modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule C: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received Modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1 (Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received Modakafusp alfa 1.5 mg/kg, infusion, IV, Q1W on Days 1 and 8.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set title	Part1(Dose Escalation)Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: (Dose Expansion) Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg
Subject analysis set type	Per protocol
Subject analysis set description	Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Arm: Part 2: Schedule D: Modakafusp Alfa+Dexamethasone
Subject analysis set type	Safety analysis
Subject analysis set description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Subject analysis set title	Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Japan Lead-in: Modakafusp Alfa 60 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Subject analysis set title	Japan Lead-in: Modakafusp Alfa 120 mg
Subject analysis set type	Full analysis
Subject analysis set description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

End points Top of page

Primary: Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs) Top of page
End point title	Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs) [1]
End point description	An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 100 100 100 100
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs) Top of page

Primary: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) Top of page
End point title	Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) [2]
End point description	DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs. The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of modakafusp alfa or experienced a DLT in Cycle 1 in the Part 1 Dose Escalation portion of the study.
End point type	Primary
End point timeframe	Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 13 6 7 21 Units: percentage of participants     number (not applicable) 4 3 0 3
No statistical analyses for this end point

Primary: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) Top of page

Primary: Part 1: Percentage of Participants Reporting one or More Grade 3 or Higher TEAEs Top of page
End point title	Part 1: Percentage of Participants Reporting one or More Grade 3 or Higher TEAEs [3]
End point description	An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 95 100 85.7 95.2
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants Reporting one or More Grade 3 or Higher TEAEs Top of page

Primary: Part 1: Percentage of Participants Reporting one or More Serious Treatment-emergent Adverse Events (Serious TEAEs) Top of page
End point title	Part 1: Percentage of Participants Reporting one or More Serious Treatment-emergent Adverse Events (Serious TEAEs) [4]
End point description	AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable&unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE:any AE either reported for first time/worsening of pre-existing event after first dose of study drug&within 30 days of last administration of study drug. Serious TEAEs:any untoward medical occurrence that:results in death,is life-threatening,requires inpatient hospitalization or prolongation of existing hospitalization,results in persistent/significant disability/incapacity,leads to congenital anomaly/birth defect in offspring of participant/is medically important event. Percentages were rounded off to nearest decimal. Analysis population: SAS.
End point type	Primary
End point timeframe	Up to approximately 54.3 months in Part 1
Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 40 75 28.6 61.9
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants Reporting one or More Serious Treatment-emergent Adverse Events (Serious TEAEs) Top of page

Primary: Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE Top of page
End point title	Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE [5]
End point description	An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 15 25 0 14.3
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE Top of page

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay Top of page
End point title	Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay [6]
End point description	Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 30 12.5 57.1 9.5
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay Top of page

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions Top of page
End point title	Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions [7]
End point description	Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 10 12.5 0 9.5
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions Top of page

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions Top of page
End point title	Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions [8]
End point description	Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 20 8 7 21 Units: percentage of participants     number (not applicable) 15 0 0 0
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions Top of page

Primary: Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements Top of page
End point title	Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements [9]
End point description	Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The protocol pre-specified categorization of vital sign values to ‘Clinically Significant’ or ‘Non-significant’, planned to be done by Investigator, could not be performed due to early termination of the study.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 0 [10] 0 [11] 0 [12] 0 [13] Units: percentage of participants     number (not applicable)
Notes [10] - No participants analysed due to early termination of study. [11] - No participants analysed due to early termination of study. [12] - No participants analysed due to early termination of study. [13] - No participants analysed due to early termination of study.
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements Top of page

Primary: Part 1: Percentage of Participants With Clinically Significant Laboratory Values Top of page
End point title	Part 1: Percentage of Participants With Clinically Significant Laboratory Values [14]
End point description	Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator’s interpretation. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The protocol pre-specified categorization of vital sign values to ‘Clinically Significant’ or ‘Non-significant’, planned to be done by Investigator, could not be performed due to early termination of the study.
End point type	Primary
End point timeframe	Up to 54.3 months in Part 1
Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 0 [15] 0 [16] 0 [17] 0 [18] Units: percentage of participants     number (not applicable)
Notes [15] - No participants analysed due to early termination of study. [16] - No participants analysed due to early termination of study. [17] - No participants analysed due to early termination of study. [18] - No participants analysed due to early termination of study.
No statistical analyses for this end point

Primary: Part 1: Percentage of Participants With Clinically Significant Laboratory Values Top of page

Primary: Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC) Top of page
End point title	Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC) [19]
End point description	ORR: percentage of participants who achieved PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein &reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR:negative immunofixation of serum& urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Scr: CR+normal FLC ratio &absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Due to early termination, IRC was disbanded prior to completing its evaluation and could not be utilized for the assessment, therefore the data for this outcome measure is not available.
End point type	Primary
End point timeframe	Up to 20.5 months in Part 3
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 0 [20] 0 [21] Units: percentage of participants     number (confidence interval 95%) ( to ) ( to )
Notes [20] - No participants analysed for this endpoint due to early termination of the study. [21] - No participants analysed for this endpoint due to early termination of the study.
No statistical analyses for this end point

Primary: Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC) Top of page

Primary: Part 2: Overall Response Rate (ORR) Top of page
End point title	Part 2: Overall Response Rate (ORR) [22]
End point description	ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response [sCR] + complete response [CR] + very good partial response [VGPR] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline.
End point type	Primary
End point timeframe	Up to 34.7 months in Part 2
Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint.
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 8 3 25 25 Units: percentage of participants     number (confidence interval 95%) 0 (0.00 to 36.94) 0 (0.00 to 70.76) 48 (27.80 to 68.69) 32 (14.95 to 53.50)
No statistical analyses for this end point

Primary: Part 2: Overall Response Rate (ORR) Top of page

Secondary: Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events Top of page
End point title	Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
End point description	Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for >7 consecutive days; Grade 4 thrombocytopenia for >14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing >2-week delay in the next scheduled infusion before the initiation of Cycle 2 were considered a DLT. Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Subjects analysed is the number of participants with data available for analysis.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 20 8 8 3 7 25 21 8 Units: percentage of participants     number (not applicable) 10 12.5 0 66.7 0 24 9.5 25
No statistical analyses for this end point

Secondary: Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events Top of page

Secondary: Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa Top of page
End point title	Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The Pharmacokinetic (PK) Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subject analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg Part1(Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule C: Modakafusp alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg Part1 (Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Number of subjects analysed 3 6 3 3 4 4 4 2 6 3 Units: nanograms per milliliter (ng/mL) geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,6,3,3,4,4,4,2,6,3) 14.7 ( 47.6 ) 154 ( 95.5 ) 2980 ( 29.0 ) 11800 ( 33.5 ) 1260 ( 106.1 ) 2230 ( 53.8 ) 2460 ( 38.6 ) 15000 ( 20.0 ) 11600 ( 30.9 ) 15900 ( 27.1 )     Cycle 1 Day 15 (n=3,4,3,2,3,3,0,0,0,0) 16.9 ( 75.4 ) 289 ( 71.8 ) 2750 ( 18.1 ) 11900 ( 40.8 ) 1030 ( 183.5 ) 2600 ( 37.9 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1 (n=2,1,2,0,0,1,3,2,5,2) 47.5 ( 175.1 ) 158 ( 99999 ) 3030 ( 10.1 ) 9999 ( 999999 ) 9999 ( 999999 ) 1970 ( 99999 ) 2490 ( 41.5 ) 15100 ( 2.3 ) 9690 ( 21.3 ) 16800 ( 31.3 )     Cycle 2 Day 15 (n=0,0,0,0,1,1,0,0,0,0) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 1730 ( 99999 ) 1270 ( 99999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )
No statistical analyses for this end point

Secondary: Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa Top of page

Secondary: Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa Top of page
End point title	Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '999' denotes median and full range were not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part1 (Dose Escalation) Schedule A: Modakafusp alfa 0.4 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.75 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.2 mg/kg Part1 (Dose Escalation) Schedule B: Modakafusp alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 0.75 mg/kg Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Number of subjects analysed 3 6 3 3 4 4 4 2 6 3 Units: hours median (full range (min-max))     Cycle 1 Day 1 (n=3,6,3,3,4,4,4,2,6,3) 4.03 (3.97 to 4.15) 3.99 (1.95 to 4.25) 4.40 (3.92 to 6.10) 4.27 (4.00 to 6.28) 4.75 (3.97 to 5.60) 4.03 (4.00 to 4.10) 4.78 (3.87 to 6.05) 3.07 (2.07 to 4.07) 4.94 (4.00 to 6.02) 4.03 (3.77 to 7.65)     Cycle 1 Day 15 (n=3,4,3,2,3,3,0,0,0,0) 3.93 (2.02 to 4.05) 4.02 (3.93 to 4.20) 4.25 (4.08 to 4.35) 5.87 (5.78 to 5.95) 4.28 (4.15 to 6.17) 4.00 (4.00 to 4.10) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999)     Cycle 2 Day 1 (n=2,1,2,0,0,1,3,2,5,2) 2.97 (1.97 to 3.98) 4.23 (4.23 to 4.23) 3.98 (3.90 to 4.05) 999 (999 to 999) 999 (999 to 999) 4.45 (4.45 to 4.45) 4.00 (3.90 to 5.92) 3.21 (2.23 to 4.18) 4.13 (3.90 to 5.95) 5.52 (3.98 to 7.05)     Cycle 2 Day 15 (n=0,0,0,0,1,1,0,0,0,0) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999) 5.65 (5.65 to 5.65) 4.00 (4.00 to 4.00) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999) 999 (999 to 999)
No statistical analyses for this end point

Secondary: Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa Top of page

Secondary: Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa Top of page
End point title	Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation)Schedule A: Modakafusp alfa 0.01 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1(Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 0 [23] 2 3 3 1 2 1 2 4 3 Units: hour*nanogram per milliliter (h*ng/mL) geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=0,0,1,3,0,2,1,2,4,3) ( ) 9999 ( 999999 ) 14900 ( 99999 ) 209000 ( 83.4 ) 9999 ( 999999 ) 20500 ( 33.2 ) 14100 ( 99999 ) 288000 ( 44.5 ) 199000 ( 104.4 ) 240000 ( 109.7 )     Cycle 1 Day 15 (n=0,2,3,2,1,2,0,0,0,0) ( ) 2410 ( 21.3 ) 24000 ( 38.0 ) 286000 ( 66.5 ) 24300 ( 99999 ) 20100 ( 21.7 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1 (n=0,0,2,0,0,0,1,2,4,1) ( ) 9999 ( 999999 ) 28000 ( 49.3 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 73600 ( 99999 ) 333000 ( 54.0 ) 243000 ( 54.5 ) 215000 ( 99999 )
Notes [23] - No participants were analysed.
No statistical analyses for this end point

Secondary: Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa Top of page

Secondary: Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa Top of page
End point title	Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Number of subjects analysed 2 6 3 3 4 4 4 2 6 3 Units: h*ng/mL geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=2,6,3,3,4,4,4,2,6,3) 29.5 ( 19.0 ) 550 ( 111.6 ) 30100 ( 67.9 ) 208000 ( 83.2 ) 7090 ( 263.7 ) 10600 ( 98.0 ) 17900 ( 106.8 ) 287000 ( 44.5 ) 197000 ( 83.9 ) 229000 ( 107.7 )     Cycle 1 Day 15 (n=2,4,3,2,3,3,0,0,0,0) 76.3 ( 34.8 ) 1270 ( 88.4 ) 23900 ( 38.2 ) 285000 ( 66.1 ) 8710 ( 514.0 ) 19200 ( 17.0 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1 (n=2,1,2,0,0,1,3,2,5,2) 128 ( 113.1 ) 584 ( 99999 ) 27700 ( 48.5 ) 9999 ( 999999 ) 9999 ( 999999 ) 6020 ( 99999 ) 15600 ( 225.4 ) 332000 ( 54.0 ) 190000 ( 77.5 ) 582000 ( 250.5 )     Cycle 2 Day 15 (n=0,0,0,0,1,1,0,0,0,0) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 22200 ( 99999 ) 5090 ( 99999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )
No statistical analyses for this end point

Secondary: Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa Top of page

Secondary: Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa Top of page
End point title	Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 0 [24] 2 3 3 1 2 1 2 4 3 Units: per hour (1/hour) geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=0,0,1,3,0,2,1,2,4,3) ( ) 9999 ( 999999 ) 0.309 ( 99999 ) 0.0933 ( 26.2 ) 9999 ( 999999 ) 0.294 ( 3.1 ) 0.265 ( 99999 ) 0.0924 ( 0.5 ) 0.107 ( 88.7 ) 0.113 ( 117.8 )     Cycle 1 Day 15 (n=0,2,3,2,1,2,0,0,0,0) ( ) 0.162 ( 4.3 ) 0.207 ( 34.6 ) 10.0852 ( 20.6 ) 0.115 ( 99999 ) 0.179 ( 59.7 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1(n=0,0,2,0,0,0,1,2,4,1) ( ) 9999 ( 999999 ) 0.197 ( 12.7 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 0.0907 ( 99999 ) 0.0528 ( 10.1 ) 0.0828 ( 14.6 ) 0.0961 ( 99999 )
Notes [24] - No participants were analysed.
No statistical analyses for this end point

Secondary: Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa Top of page

Secondary: Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa Top of page
End point title	Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa
End point description	As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation)Schedule D:Modakafusp Alfa 0.75 mg/kg Part1(Dose Escalation) Schedule D: Modakafusp alfa 1.5 mg/kg Number of subjects analysed 0 [25] 2 3 3 1 2 1 2 4 3 Units: hours geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=0,0,1,3,0,2,1,2,4,3) ( ) 9999 ( 999999 ) 2.24 ( 99999 ) 7.43 ( 26.2 ) 9999 ( 999999 ) 2.36 ( 3.1 ) 2.61 ( 99999 ) 7.50 ( 0.4 ) 6.51 ( 88.6 ) 6.16 ( 117.7 )     Cycle 1 Day 15 (n=0,2,3,2,1,2,0,0,0,0) ( ) 4.28 ( 4.3 ) 3.36 ( 34.6 ) 8.14 ( 20.6 ) 6.01 ( 99999 ) 3.87 ( 59.7 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1(n=0,0,2,0,0,0,1,2,4,1) ( ) 9999 ( 999999 ) 3.52 ( 12.8 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 7.64 ( 99999 ) 13.1 ( 10.1 ) 8.37 ( 14.6 ) 7.22 ( 99999 )
Notes [25] - No participants were available for analyses.
No statistical analyses for this end point

Secondary: Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa Top of page

Secondary: Part 1: CL: Clearance for Modakafusp alfa Top of page
End point title	Part 1: CL: Clearance for Modakafusp alfa
End point description	Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for the specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule C:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 0 [26] 2 3 3 1 2 1 2 4 3 Units: liters per hour per kilogram (L/h/kg) geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=0,0,1,3,0,2,1,2,4,3) ( ) 9999 ( 999999 ) 0.0268 ( 99999 ) 0.00358 ( 83.7 ) 9999 ( 999999 ) 0.0147 ( 32.9 ) 0.0283 ( 99999 ) 0.00258 ( 45.3 ) 0.00380 ( 102.9 ) 0.00628 ( 108.4 )     Cycle 1 Day 15 (n=0,2,3,2,1,2,0,0,0,0) ( ) 0.0415 ( 21.3 ) 0.0167 ( 37.9 ) 0.00261 ( 66.5 ) 0.00820 ( 99999 ) 0.0149 ( 22.0 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1 (n=0,0,2,0,0,0,1,2,4,1) ( ) 9999 ( 999999 ) 0.0143 ( 49.2 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 0.00540 ( 99999 ) 0.00226 ( 52.1 ) 0.00306 ( 55.3 ) 0.00700 ( 99999 )
Notes [26] - No participants were available for analyses.
No statistical analyses for this end point

Secondary: Part 1: CL: Clearance for Modakafusp alfa Top of page

Secondary: Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa Top of page
End point title	Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa
End point description	Volume of distribution: theoretical volume in which total amount of drug would need to be uniformly distributed to produce desired serum concentration of a drug. V(ss)=(dose/AUC)*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected&reported dose-wise for each treatment schedule. PK Analysis Set: participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed: participants with data available for analysis. 'n' denotes number of participants with data available for analysis during specified time-point. '99999' denotes geometric coefficient of variation was not estimable for a single participant. '9999' denotes geometric mean was not available for specified time-point as no participants were analysed at that time-point. '999999' denotes geometric coefficient of variation was not available for the specified time-point as no participants were analysed at that time-point.
End point type	Secondary
End point timeframe	Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
End point values Part1(Dose Escalation) Schedule A: Modakafusp alfa 0.01 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg Part 1 (Dose Escalation) Schedule A:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg Part 1(Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D:Modakafusp Alfa 0.75 mg/kg Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 0 [27] 2 3 3 1 2 1 2 4 3 Units: liters/kg geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=0,0,1,3,0,2,1,2,4,3) ( ) 9999 ( 999999 ) 0.104 ( 99999 ) 0.0352 ( 23.4 ) 9999 ( 999999 ) 0.0575 ( 26.4 ) 0.117 ( 99999 ) 0.0329 ( 32.1 ) 0.0390 ( 27.1 ) 0.0536 ( 24.3 )     Cycle 1 Day 15 (n=0,2,3,2,1,2,0,0,0,0) ( ) 0.150 ( 24.6 ) 0.0675 ( 36.9 ) 0.0319 ( 43.3 ) 0.0660 ( 99999 ) 0.0624 ( 14.2 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 )     Cycle 2 Day 1 (n=0,0,2,0,0,0,1,2,4,1) ( ) 9999 ( 999999 ) 0.0678 ( 31.1 ) 9999 ( 999999 ) 9999 ( 999999 ) 9999 ( 999999 ) 0.0640 ( 99999 ) 0.0456 ( 36.9 ) 0.0404 ( 26.8 ) 0.0716 ( 99999 )
Notes [27] - No participants were available for analyses.
No statistical analyses for this end point

Secondary: Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa Top of page

Secondary: Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibody (ADA) at any Scheduled and Unscheduled Post-Baseline Visit Top of page
End point title	Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibody (ADA) at any Scheduled and Unscheduled Post-Baseline Visit
End point description	ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal. The Immunogenicity-evaluable Analysis Set included participants from the SAS with a baseline assessment and at least 1 postbaseline immunogenicity assessment. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 17 7 65 6 3 65 6 21 18 7 Units: percentage of participants     number (not applicable) 41.2 57.1 52.3 83.3 66.7 61.5 83.3 61.9 66.7 14.3
No statistical analyses for this end point

Secondary: Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibody (ADA) at any Scheduled and Unscheduled Post-Baseline Visit Top of page

Secondary: Part 1: Overall Response Rate (ORR) Top of page
End point title	Part 1: Overall Response Rate (ORR)
End point description	ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. Percentages were rounded off to the nearest decimal. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1
End point values Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 1 (Dose Escalation) Schedule C Part 1 (Dose Escalation) Schedule D Number of subjects analysed 19 8 7 21 Units: percentage of participants     number (confidence interval 95%) 15.8 (3.8 to 39.58) 0 (0.00 to 36.94) 0 (0.00 to 40.96) 23.8 (8.22 to 47.17)
No statistical analyses for this end point

Secondary: Part 1: Overall Response Rate (ORR) Top of page

Secondary: Parts 1 and 2: Clinical Benefit Rate (CBR) Top of page
End point title	Parts 1 and 2: Clinical Benefit Rate (CBR)
End point description	CBR: percentage of participants with confirmed response of sCR,CR,VGPR,PR/minimal response(MR) during study per investigator assessment as per by IMWG Uniform Response Criteria. PR:≥50% reduction of serum M-protein&reduction in 24-hour urinary M-protein by ≥90%/to <200 mg/24 hours. CR:negative immunofixation of serum&urine, disappearance of any soft tissue plasmacytomas,&<5% plasma cells in bone marrow.sCR:CR+normal FLC ratio&absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum&urine M-protein detectable by immunofixation but not on electrophoresis,or≥90% reduction in serum M-protein plus urine M-protein<100 mg/24 hours.MR:≥25% but≤49% reduction of serum M-protein&reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to nearest decimal.SAS: all enrolled subjects who received at least 1 dose,even if incomplete,of TAK-57&with measurable disease at baseline. Subjects analysed: number of participants with data available for analysis.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 19 8 8 3 7 25 21 25 Units: percentage of participants     number (confidence interval 95%) 15.8 (3.38 to 39.58) 0 (0.00 to 36.94) 0 (0.00 to 36.94) 0 (0.00 to 70.76) 0 (0.00 to 40.96) 52.0 (31.31 to 72.20) 38.1 (18.11 to 61.56) 32.0 (14.95 to 53.50)
No statistical analyses for this end point

Secondary: Parts 1 and 2: Clinical Benefit Rate (CBR) Top of page

Secondary: Parts 1 and 2: Disease Control Rate (DCR) Top of page
End point title	Parts 1 and 2: Disease Control Rate (DCR)
End point description	DCR:proportion of participants with confirmed response of sCR,CR,VGPR,PR,MR,or stable disease(SD) during study per investigator assessment as defined by IMWG Uniform Response Criteria.PR:≥50% reduction of serum M-protein&reduction in 24-hour urinary M-protein by≥90%/ to <200 mg/24 hours.CR:negative immunofixation of serum&urine, disappearance of any soft tissue plasmacytomas,&<5% plasma cells in bone marrow.sCR:CR+normal FLC ratio&absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum&urine M-protein detectable by immunofixation but not on electrophoresis/≥90% reduction in serum M-protein plus urine M-protein<100 mg/24 hours.MR:≥25% but ≤49% reduction of serum M-protein&reduction in 24-hour urine M-protein by 50% to 89%.SD:no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages were rounded off to nearest decimal.Analysis population:SAS.Subjects analysed:number of participants with data available for analysis.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 19 8 8 3 7 25 21 25 Units: percentage of participants     number (confidence interval 95%) 57.9 (33.50 to 79.75) 62.5 (24.49 to 91.48) 37.5 (8.52 to 75.51) 66.7 (9.43 to 99.16) 42.9 (9.90 to 81.59) 64.0 (42.52 to 82.03) 61.9 (38.44 to 81.89) 68.0 (46.50 to 85.05)
No statistical analyses for this end point

Secondary: Parts 1 and 2: Disease Control Rate (DCR) Top of page

Secondary: Parts 1, 2, and 3: Duration of Response (DOR) Top of page
End point title	Parts 1, 2, and 3: Duration of Response (DOR)
End point description	DOR was defined as the time from the date of first documentation of response PR or better (sCR + CR + VGPR + PR) to the time of disease progression or death, whichever occurs first. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Subjects analysed is the number of participants with data available for analyses. '9.99' denotes median was not estimable due to low number of participants with events.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 3 0 [28] 6 0 [29] 0 [30] 13 0 [31] 7 2 3 Units: months     median (full range (min-max)) 2.1 (2.0 to 12.0) ( to ) 9.99 (2.07 to 13.57) ( to ) ( to ) 9.2 (0.76 to 16.82) ( to ) 24.4 (1.0 to 39.7) 7.4 (2.8 to 24.8) 10.3 (1.0 to 17.6)
Notes [28] - No participants analysed due to early termination of study. [29] - No participants analysed due to early termination of study. [30] - No participants analysed due to early termination of study. [31] - No participants analysed due to early termination of study.
No statistical analyses for this end point

Secondary: Parts 1, 2, and 3: Duration of Response (DOR) Top of page

Secondary: Parts 1 and 2: Time to Response Top of page
End point title	Parts 1 and 2: Time to Response
End point description	Time to response was defined as the time from first dose to the date of first documentation of response (PR or better [sCR + CR + VGPR + PR]) PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 3 0 [32] 0 [33] 0 [34] 0 [35] 12 5 8 Units: months     median (full range (min-max)) 1.15 (1.0 to 3.0) ( to ) ( to ) ( to ) ( to ) 1.07 (0.8 to 5.8) 1.87 (0.9 to 3.7) 1.08 (1.0 to 10.0)
Notes [32] - No participants analysed due to early termination of study. [33] - No participants analysed due to early termination of study. [34] - No participants analysed due to early termination of study. [35] - No participants analysed due to early termination of study.
No statistical analyses for this end point

Secondary: Parts 1 and 2: Time to Response Top of page

Secondary: Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa Top of page
End point title	Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 7 3 21 6 Units: ng/mL geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=7,3,21,6) 3540 ( 83.7 ) 4330 ( 23.7 ) 32100 ( 25.4 ) 35700 ( 20.0 )     Cycle 2 Day 1 (n=6,3,16,4) 3450 ( 51.2 ) 3870 ( 26.6 ) 34200 ( 24.6 ) 36100 ( 25.6 )
No statistical analyses for this end point

Secondary: Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa Top of page

Secondary: Parts 2 and 3: Overall Survival (OS) Top of page
End point title	Parts 2 and 3: Overall Survival (OS)
End point description	The OS was defined as the time from the date of first dose to the date of death due to any cause. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses. '9.99' indicates that median was not estimable due to censoring.
End point type	Secondary
End point timeframe	Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 3 1 3 2 18 17 Units: months     median (full range (min-max)) 9.99 (1.5 to 19.9) 9.99 (1.7 to 15.2) 9.99 (0.5 to 22.3) 3.4 (1.0 to 3.7) 9.99 (1.08 to 17.25) 9.99 (0.39 to 19.81)
No statistical analyses for this end point

Secondary: Parts 2 and 3: Overall Survival (OS) Top of page

Secondary: Parts 1, 2, and 3: Progression Free Survival (PFS) Top of page
End point title	Parts 1, 2, and 3: Progression Free Survival (PFS)
End point description	PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjcets analysed is the number of participants with data available for analysis.
End point type	Secondary
End point timeframe	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
End point values Part 1 (Dose Escalation) Schedule A Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 1 (Dose Escalation) Schedule B Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 1 (Dose Escalation) Schedule C Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Part 1 (Dose Escalation) Schedule D Part 2: Schedule D: Modakafusp Alfa+Dexamethasone Number of subjects analysed 15 7 43 7 2 44 6 18 15 13 Units: months     median (full range (min-max)) 2.6 (0.0 to 13.1) 1.1 (0.5 to 2.3) 4.1 (0.03 to 15.44) 1.5 (0.2 to 5.4) 1.4 (0.7 to 1.4) 5.3 (0.03 to 19.81) 1.4 (0.1 to 6.2) 8.0 (0.0 to 40.4) 3.6 (0.0 to 26.5) 3.4 (0.0 to 22.7)
No statistical analyses for this end point

Secondary: Parts 1, 2, and 3: Progression Free Survival (PFS) Top of page

Secondary: Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa Top of page
End point title	Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg Number of subjects analysed 3 2 19 6 Units: h*ng/mL geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,2,19,6) 24900 ( 77.1 ) 42700 ( 19.2 ) 1020000 ( 89.1 ) 1280000 ( 70.4 )     Cycle 2 Day 1 (n=2,2,16,3) 37200 ( 35.4 ) 43700 ( 118.5 ) 1520000 ( 60.7 ) 2070000 ( 33.9 )
No statistical analyses for this end point

Secondary: Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa Top of page

Secondary: Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa Top of page
End point title	Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg Part 2: Schedule C: Modakafusp alfa 0.4 mg/kg + Dex 40 mg Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg Part 2: Schedule D: Modakafusp alfa 1.5 mg/kg + Dex 40 mg Number of subjects analysed 3 2 21 6 Units: 1/h geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,2,21,6) 0.114 ( 67.0 ) 0.111 ( 31.0 ) 0.0478 ( 63.6 ) 0.0468 ( 62.8 )     Cycle 2 Day 1 (n=2,2,16,4) 0.127 ( 80.1 ) 0.171 ( 64.0 ) 0.0381 ( 36.9 ) 0.0276 ( 54.4 )
No statistical analyses for this end point

Secondary: Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa Top of page

Secondary: Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa Top of page
End point title	Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 7 3 21 6 Units: h*ng/mL geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=7,3,21,6) 40800 ( 93.6 ) 34600 ( 40.0 ) 975000 ( 90.8 ) 1280000 ( 70.4 )     Cycle 2 Day 1 (n=6,3,16,4) 42300 ( 64.8 ) 45600 ( 74.7 ) 1510000 ( 62.5 ) 1650000 ( 56.3 )
No statistical analyses for this end point

Secondary: Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa Top of page

Secondary: Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa Top of page
End point title	Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analysis. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 7 3 21 6 Units: hours median (full range (min-max))     Cycle 1 Day 1 (n=7,3,21,6) 5.70 (4.08 to 7.73) 3.27 (2.60 to 9.00) 1.18 (0.93 to 3.00) 1.68 (1.07 to 6.57)     Cycle 2 Day 1(n=6,3,16,4) 5.68 (3.88 to 6.68) 3.30 (1.12 to 9.00) 1.29 (0.90 to 4.88) 1.63 (1.10 to 3.00)
No statistical analyses for this end point

Secondary: Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa Top of page

Secondary: Part 2: CL: Clearance for Modakafusp alfa Top of page
End point title	Part 2: CL: Clearance for Modakafusp alfa
End point description	Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analyses. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 3 2 19 6 Units: L/h/kg geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,2,19,6) 0.0160 ( 77.4 ) 0.00937 ( 19.0 ) 0.00147 ( 89.9 ) 0.00119 ( 67.9 )     Cycle 2 Day 1 (n=2,2,16,3) 0.0107 ( 35.6 ) 0.00912 ( 118.7 ) 0.000995 ( 61.2 ) 0.000737 ( 36.5 )
No statistical analyses for this end point

Secondary: Part 2: CL: Clearance for Modakafusp alfa Top of page

Secondary: Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa Top of page
End point title	Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa
End point description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)*MRT, where MRT is mean residence time. The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analyses. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2: (Dose Expansion) Schedule D: Modakafusp alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 3 2 19 6 Units: L/kg geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,2,19,6) 0.114 ( 32.8 ) 0.0646 ( 4.7 ) 0.0260 ( 67.6 ) 0.0276 ( 16.7 )     Cycle 2 Day 1(n=2,2,16,3) 0.0779 ( 32.2 ) 0.0501 ( 41.8 ) 0.0289 ( 39.6 ) 0.0260 ( 13.7 )
No statistical analyses for this end point

Secondary: Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa Top of page

Secondary: Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa Top of page
End point title	Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa
End point description	The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Subjects analysed is the number of participants with data available for analyses. 'n' denotes the number of participants with data available for analysis during the specified time-point.
End point type	Secondary
End point timeframe	Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
End point values Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg Number of subjects analysed 3 2 21 6 Units: hours geometric mean (geometric coefficient of variation)     Cycle 1 Day 1 (n=3,2,21,6) 6.08 ( 67.0 ) 6.22 ( 31.0 ) 14.5 ( 63.6 ) 14.8 ( 62.8 )     Cycle 2 Day 1 (n=2,2,16,4) 5.46 ( 80.1 ) 4.07 ( 64.0 ) 18.2 ( 36.9 ) 25.1 ( 54.2 )
No statistical analyses for this end point

Secondary: Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp alfa Top of page

Secondary: Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment Top of page
End point title	Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment
End point description	DCR:proportion of participants with confirmed response of sCR,CR, VGPR,PR,MR/SD during study per investigator assessment as defined by IMWG Uniform Response Criteria. PR:≥50% reduction of serum M-protein&reduction in 24-hour urinary M-protein by ≥90%/to<200 mg/24 hours. CR:negative immunofixation of serum&urine,disappearance of any soft tissue plasmacytomas,&<5% plasma cells in bone marrow.sCR:CR+normal FLC ratio&absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum&urine M-protein detectable by immunofixation but not on electrophoresis,or ≥90% reduction in serum M-protein plus urine M-protein<100 mg/24 hours.MR:≥25% but ≤49% reduction of serum M-protein&reduction in 24-hour urine M-protein by 50% to 89%. SD:no known evidence of progressive/new bone lesions if radiographic studies were performed. Percentages were rounded off to nearest decimal. The FAS: all subjects who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in Part 3.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: percentage of participants     number (confidence interval 95%) 74.6 (62.92 to 84.23) 68.0 (56.22 to 78.311)
No statistical analyses for this end point

Secondary: Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment Top of page

Secondary: Part 3: Duration of Clinical Benefit Top of page
End point title	Part 3: Duration of Clinical Benefit
End point description	Duration of clinical benefit was defined as the time from first documented evidence of confirmed MR or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieve a confirmed MR or better. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses. Participants with no post baseline response assessment were censored.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 30 25 Units: months     median (confidence interval 95%) 6.5 (0.03 to 14.52) 5.6 (0.03 to 18.89)
No statistical analyses for this end point

Secondary: Part 3: Duration of Clinical Benefit Top of page

Secondary: Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment Top of page
End point title	Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment
End point description	CBR: percentage of participants with confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to nearest decimal. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: percentage of participants     number (confidence interval 95%) 38.0 (26.76 to 50.33) 48.0 (36.31 to 59.85)
No statistical analyses for this end point

Secondary: Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment Top of page

Secondary: Part 3: Objective Response Rate (ORR) by Investigator Assessment Top of page
End point title	Part 3: Objective Response Rate (ORR) by Investigator Assessment
End point description	ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. Percentages were rounded off to the nearest decimal. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: percentage of participants     number (confidence interval 95%) 32.4 (21.76 to 44.55) 41.3 (30.08 to 53.30)
No statistical analyses for this end point

Secondary: Part 3: Objective Response Rate (ORR) by Investigator Assessment Top of page

Secondary: Part 3: Time to Progression (TTP) by IRC and Investigator Assessment Top of page
End point title	Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
End point description	TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 37 39 Units: months     median (full range (min-max)) 4.7 (0.03 to 15.44) 5.5 (0.03 to 19.81)
No statistical analyses for this end point

Secondary: Part 3: Time to Progression (TTP) by IRC and Investigator Assessment Top of page

Secondary: Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status Top of page
End point title	Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
End point description	ECOG performance status was measured at baseline and over time. ECOG performance status was measured on a 6 point scale: Grade 0: Normal activity, Grade 1: Symptoms but ambulatory, Grade 2: In bed <50% of the time, Grade 3: In bed >50% of the time, Grade 4: 100% bedridden, Grade 5: Dead. Reported here is the baseline status and the worst post-baseline status measured. A decrease in grade from baseline indicates an improvement. Only categories for which there was at least 1 participant are reported. The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: participants     Baseline: 0; Worst Post-baseline: 0 11 6     Baseline: 0; Worst Post-baseline: 1 5 12     Baseline: 0; Worst Post-baseline: 2 2 1     Baseline: 0; Worst Post-baseline: 3 0 1     Baseline: 1; Worst Post-baseline: 0 1 0     Baseline: 1; Worst Post-baseline: 1 31 25     Baseline: 1; Worst Post-baseline: 2 6 12     Baseline: 1; Worst Post-baseline: 3 3 1     Baseline: 1; Worst Post-baseline: 4 1 0     Baseline: 2; Worst Post-baseline: 2 6 4     Baseline: 2; Worst Post-baseline: 3 1 1     Baseline: 2; Worst Post-baseline: 4 1 0
No statistical analyses for this end point

Secondary: Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status Top of page

Secondary: Part 3: Percentage of Participants With Clinically Significant Laboratory Values Top of page
End point title	Part 3: Percentage of Participants With Clinically Significant Laboratory Values
End point description	Laboratory values included hematology, chemistry, and urinalysis as interpreted by the investigator. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. The protocol pre-specified categorization of laboratory values to ‘Clinically Significant’ or ‘Non-significant’, planned to be done by Investigator, could not be performed due to early termination of the study.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 0 [36] 0 [37] Units: percentage of participants     number (not applicable)
Notes [36] - No participants were analysed due to early termination of the study. [37] - No participants were analysed due to early termination of the study.
No statistical analyses for this end point

Secondary: Part 3: Percentage of Participants With Clinically Significant Laboratory Values Top of page

Secondary: Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) Top of page
End point title	Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs)
End point description	AE:any untoward medical occurrence in participants administered pharmaceutical product;untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable&unintended sign(including abnormal laboratory finding),symptom/disease temporally associated with use of medicinal (investigational) product whether/not it is related to medicinal product.TEAE:any AE either reported for first time/worsening of pre-existing event after first dose of study drug&within 30 days of last administration of study drug.Serious TEAEs:any untoward medical occurrence that:results in death,is life-threatening,requires inpatient hospitalization/prolongation of existing hospitalization,results in persistent/significant disability/incapacity,leads to congenital anomaly/birth defect in offspring of participant/is medically important event. Percentages were rounded off to nearest decimal. Analysis population: FAS.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: percentage of participants     number (not applicable) 39.4 44.0
No statistical analyses for this end point

Secondary: Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) Top of page

Secondary: Part 3: Duration of Disease Control Top of page
End point title	Part 3: Duration of Disease Control
End point description	Duration of disease control was defined as the time from first documented evidence of SD or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieved a SD or better. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 30 25 Units: months     median (full range (min-max)) 6.5 (0.03 to 14.52) 5.6 (0.03 to 18.89)
No statistical analyses for this end point

Secondary: Part 3: Duration of Disease Control Top of page

Secondary: Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR Top of page
End point title	Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
End point description	MRD negativity rate at a sensitivity of 10^-5 was defined as participants who were MRD negative at a sensitivity of 10^-5 in participants achieving suspected complete response (CR). CR was defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria was required. The Intent-to-Treat (ITT) Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 6 1 Units: participants 3 1
No statistical analyses for this end point

Secondary: Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR Top of page

Secondary: Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR Top of page
End point title	Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
End point description	Duration of MRD negativity (10^-5) was defined as the time from the first MRD negative status (10^-5) to the earliest date of the MRD positive status (10^-5), confirmed PD per IMWG or death. Due to early termination of the study the complete data for pre-planned analysis of duration of MRD was not collected based on sponsor decision.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 0 [38] 0 [39] Units: months
Notes [38] - Duration of MRD was not collected based on sponsor decision due to early termination of the study. [39] - Duration of MRD was not collected based on sponsor decision due to early termination of the study.
No statistical analyses for this end point

Secondary: Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR Top of page

Secondary: Part 3: Percentage of Participants With Treatment -emergent Adverse Events (TEAEs) Top of page
End point title	Part 3: Percentage of Participants With Treatment -emergent Adverse Events (TEAEs)
End point description	An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: percentage of participants     number (not applicable) 98.6 100
No statistical analyses for this end point

Secondary: Part 3: Percentage of Participants With Treatment -emergent Adverse Events (TEAEs) Top of page

Secondary: Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter Top of page
End point title	Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
End point description	Medical encounters included hospitalizations, emergency room stays, or outpatient visits. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 46 57 Units: participants     Hospitalizations 29 31     Emergency Room Stays 7 8     All Outpatient Visits 10 18
No statistical analyses for this end point

Secondary: Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter Top of page

Secondary: Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit Top of page
End point title	Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit
End point description	Percentages were rounded off to the nearest decimal. Immunogenicity-Evaluable Set Analysis included participants with a baseline assessment and at least 1 post-baseline immunogenicity assessment. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 65 65 Units: percentage of participants     number (not applicable) 47.7 44.6
No statistical analyses for this end point

Secondary: Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit Top of page

Secondary: Part 3: Health Care Utilization: Length of Hospital Stays Top of page
End point title	Part 3: Health Care Utilization: Length of Hospital Stays
End point description	The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Up to 20.5 months in Part 3
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 71 75 Units: days     median (full range (min-max)) 14 (2 to 240) 11 (1 to 158)
No statistical analyses for this end point

Secondary: Part 3: Health Care Utilization: Length of Hospital Stays Top of page

Secondary: Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20) Top of page
End point title	Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
End point description	EORTC QLQ-MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image). The PRO Analysis Set included all participants with a baseline and at least one post-baseline measurement of any PRO measure (EORTC QLQ-MY20 or EQ-5D-5L).Subjects analysed is the number of participants with data available for analyses.
End point type	Secondary
End point timeframe	Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)
End point values Part 3 (Dose Extension): Modakafusp Alfa 120 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Number of subjects analysed 7 6 Units: score on a scale arithmetic mean (standard deviation)     Disease Symptoms -7.9 ( 22.63 ) -7.4 ( 10.93 )     Side Effects of Treatment 4.7 ( 11.62 ) 7.0 ( 5.45 )     Body Image 4.8 ( 35.63 ) 0.0 ( 21.06 )     Future Perspective 11.1 ( 9.06 ) 7.4 ( 34.92 )
No statistical analyses for this end point

Secondary: Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20) Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
Adverse event reporting additional description	The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	26.1
Reporting groups
Reporting group title	Japan Lead-in: Modakafusp alfa 60 mg
Reporting group description	Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Reporting group description	Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule A
Reporting group description	Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule B
Reporting group description	Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Reporting group description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Japan Lead-in: Modakafusp alfa 120 mg
Reporting group description	Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Reporting group title	Part 2 (Dose Expansion): Schedule D: Modakafusp alfa
Reporting group description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2: Schedule D: Modakafusp alfa + Dexamethasone
Reporting group description	Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2 (Dose Expansion): Schedule C: Modakafusp alfa
Reporting group description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule D
Reporting group description	Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Reporting group title	Part 1 (Dose Escalation) Schedule C
Reporting group description	Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Reporting group title	Part 2: Schedule C: Modakafusp alfa + Dexamethasone
Reporting group description	Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Serious adverse events Japan Lead-in: Modakafusp alfa 60 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 3 (Dose Extension): Modakafusp Alfa 120 mg Japan Lead-in: Modakafusp alfa 120 mg Part 2 (Dose Expansion): Schedule D: Modakafusp alfa Part 2: Schedule D: Modakafusp alfa + Dexamethasone Part 2 (Dose Expansion): Schedule C: Modakafusp alfa Part 1 (Dose Escalation) Schedule D Part 1 (Dose Escalation) Schedule C Part 2: Schedule C: Modakafusp alfa + Dexamethasone Total subjects affected by serious adverse events      subjects affected / exposed 0 / 3 (0.00%) 37 / 75 (49.33%) 8 / 20 (40.00%) 6 / 8 (75.00%) 29 / 71 (40.85%) 0 / 2 (0.00%) 7 / 25 (28.00%) 9 / 25 (36.00%) 1 / 8 (12.50%) 13 / 21 (61.90%) 2 / 7 (28.57%) 1 / 3 (33.33%)      number of deaths (all causes) 0 20 15 6 19 0 5 6 3 8 6 1      number of deaths resulting from adverse events 0 5 1 2 3 0 0 3 0 2 0 0 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myelodysplastic syndrome      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Plasmacytoma      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vascular disorders Hypertension      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypotension      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 2 / 20 (10.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 2 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 General disorders and administration site conditions Asthenia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Fatigue      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Multiple organ dysfunction syndrome      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 General physical health deterioration      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Mucosal inflammation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sudden death      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pyrexia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 2 / 3 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pain      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dyspnoea      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2 1 / 1 0 / 0 1 / 1 0 / 0 2 / 2 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonitis      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypoxia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pleural effusion      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Obliterative bronchiolitis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonitis aspiration      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary alveolar haemorrhage      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary embolism      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory failure      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Stridor      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Psychiatric disorders Confusional state      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Delirium      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Mental status changes      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Investigations Aspartate aminotransferase increased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ejection fraction decreased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood creatine phosphokinase increased      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Electrophoresis protein abnormal      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 Light chain analysis increased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 General physical condition abnormal      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Troponin increased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Injury, poisoning and procedural complications Accidental overdose      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Fall      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Febrile nonhaemolytic transfusion reaction      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Femoral neck fracture      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infusion related reaction      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 2 / 2 0 / 0 0 / 0 3 / 3 0 / 0 3 / 3 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pelvic fracture      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tibia fracture      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac disorders Atrial fibrillation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acute myocardial infarction      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac arrest      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myocardial infarction      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure congestive      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sinus tachycardia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Supraventricular tachycardia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system disorders Encephalopathy      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 2 / 8 (25.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral haemorrhage      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 Haemorrhage intracranial      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haemorrhagic stroke      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 Headache      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Posterior reversible encephalopathy syndrome      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spinal cord compression      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Stupor      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood and lymphatic system disorders Anaemia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 4 0 / 1 0 / 0 1 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Febrile neutropenia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Methaemoglobinaemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Disseminated intravascular coagulation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Thrombocytopenia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 2 / 2 0 / 0 0 / 0 4 / 4 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ear and labyrinth disorders Vertigo      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal disorders Anal incontinence      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diarrhoea      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dieulafoy's vascular malformation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastric ulcer      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal haemorrhage      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower gastrointestinal haemorrhage      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nausea      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vomiting      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Odynophagia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatobiliary disorders Cholelithiasis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Pruritus      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 2 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal and urinary disorders Acute kidney injury      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0 3 / 4 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 Haematuria      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Arthritis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Back pain      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 2 / 8 (25.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 1 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bone pain      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haemarthrosis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Muscular weakness      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infections and infestations Bacterial infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bacteraemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 COVID-19 pneumonia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchiolitis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Device related sepsis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Device related bacteraemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Clostridium difficile infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Escherichia urinary tract infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumocystis jirovecii pneumonia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 0 / 3 (0.00%) 7 / 75 (9.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 6 / 71 (8.45%) 0 / 2 (0.00%) 3 / 25 (12.00%) 4 / 25 (16.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 6 / 10 0 / 1 0 / 0 0 / 6 0 / 0 0 / 3 0 / 5 0 / 0 3 / 5 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia haemophilus      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pseudomonal sepsis      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory syncytial virus infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory tract infection      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 3 / 4 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Septic shock      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sinusitis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sepsis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 2 / 20 (10.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 2 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Viral upper respiratory tract infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metabolism and nutrition disorders Hypercalcaemia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 1 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypokalaemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metabolic acidosis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Japan Lead-in: Modakafusp alfa 60 mg Part 3 (Dose Extension): Modakafusp Alfa 240 mg Part 1 (Dose Escalation) Schedule A Part 1 (Dose Escalation) Schedule B Part 3 (Dose Extension): Modakafusp Alfa 120 mg Japan Lead-in: Modakafusp alfa 120 mg Part 2 (Dose Expansion): Schedule D: Modakafusp alfa Part 2: Schedule D: Modakafusp alfa + Dexamethasone Part 2 (Dose Expansion): Schedule C: Modakafusp alfa Part 1 (Dose Escalation) Schedule D Part 1 (Dose Escalation) Schedule C Part 2: Schedule C: Modakafusp alfa + Dexamethasone Total subjects affected by non serious adverse events      subjects affected / exposed 3 / 3 (100.00%) 74 / 75 (98.67%) 20 / 20 (100.00%) 8 / 8 (100.00%) 70 / 71 (98.59%) 2 / 2 (100.00%) 24 / 25 (96.00%) 24 / 25 (96.00%) 8 / 8 (100.00%) 21 / 21 (100.00%) 7 / 7 (100.00%) 3 / 3 (100.00%) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 1 0 0 1 0 0 0 0 0 Vascular disorders Flushing      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 3 0 0 11 0 1 1 0 3 0 0 Haematoma      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 1 0 0 0 0 0 0 0 0 Hot flush      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 1 0 0 1 1 1 0 0 Shock      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Hypoperfusion      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Hypotension      subjects affected / exposed 1 / 3 (33.33%) 3 / 75 (4.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 4 / 71 (5.63%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 1 3 0 1 4 0 2 2 0 4 0 1 Hypertension      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 7 / 71 (9.86%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 0 0 11 0 1 2 0 3 0 0 Shock haemorrhagic      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 General disorders and administration site conditions Infusion site extravasation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Asthenia      subjects affected / exposed 0 / 3 (0.00%) 8 / 75 (10.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 7 / 71 (9.86%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 11 0 0 12 0 1 0 0 0 0 0 Fatigue      subjects affected / exposed 0 / 3 (0.00%) 29 / 75 (38.67%) 8 / 20 (40.00%) 2 / 8 (25.00%) 21 / 71 (29.58%) 0 / 2 (0.00%) 7 / 25 (28.00%) 6 / 25 (24.00%) 3 / 8 (37.50%) 8 / 21 (38.10%) 2 / 7 (28.57%) 1 / 3 (33.33%)      occurrences all number 0 36 11 4 25 0 7 6 3 10 2 2 Influenza like illness      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 1 0 2 0 2 0 0 0 0 0 Chills      subjects affected / exposed 0 / 3 (0.00%) 5 / 75 (6.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 7 / 71 (9.86%) 0 / 2 (0.00%) 5 / 25 (20.00%) 1 / 25 (4.00%) 2 / 8 (25.00%) 6 / 21 (28.57%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 6 0 0 10 0 7 1 3 8 1 0 Chest pain      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 3 / 25 (12.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 2 0 3 0 4 0 1 1 0 0 Chest discomfort      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 0 0 1 0 1 0 0 4 0 0 Mucosal inflammation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Non-cardiac chest pain      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 2 0 9 0 2 3 1 0 0 0 Pain      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 3 / 25 (12.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 3 0 3 1 0 1 1 0 Oedema peripheral      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 3 0 0 2 0 0 1 0 2 0 0 Pyrexia      subjects affected / exposed 1 / 3 (33.33%) 16 / 75 (21.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 8 / 71 (11.27%) 0 / 2 (0.00%) 7 / 25 (28.00%) 3 / 25 (12.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 1 18 0 0 12 0 8 4 0 5 0 1 Immune system disorders Seasonal allergy      subjects affected / exposed 1 / 3 (33.33%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 Hypogammaglobulinaemia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 6 0 0 1 0 0 1 0 0 0 0 Respiratory, thoracic and mediastinal disorders Atelectasis      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 0 1 2 0 1 0 0 1 1 0 Cough      subjects affected / exposed 0 / 3 (0.00%) 22 / 75 (29.33%) 5 / 20 (25.00%) 0 / 8 (0.00%) 12 / 71 (16.90%) 0 / 2 (0.00%) 7 / 25 (28.00%) 4 / 25 (16.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 2 / 7 (28.57%) 0 / 3 (0.00%)      occurrences all number 0 28 6 0 15 0 11 4 0 4 2 0 Dysphonia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 3 0 0 Hypoxia      subjects affected / exposed 1 / 3 (33.33%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 2 0 0 5 0 2 0 0 1 0 0 Dyspnoea exertional      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 3 / 25 (12.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 2 0 0 0 0 4 1 0 0 1 0 Epistaxis      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 0 / 25 (0.00%) 3 / 25 (12.00%) 0 / 8 (0.00%) 5 / 21 (23.81%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 4 0 4 0 0 5 0 5 0 0 Dyspnoea      subjects affected / exposed 0 / 3 (0.00%) 14 / 75 (18.67%) 2 / 20 (10.00%) 1 / 8 (12.50%) 7 / 71 (9.86%) 0 / 2 (0.00%) 5 / 25 (20.00%) 5 / 25 (20.00%) 1 / 8 (12.50%) 4 / 21 (19.05%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 20 2 1 9 0 7 5 1 6 1 0 Laryngeal inflammation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 Nasal congestion      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 2 / 20 (10.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 7 2 0 4 0 2 0 1 0 0 0 Respiratory distress      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Rhinitis allergic      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 1 0 1 0 0 0 Respiratory symptom      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 Rhinorrhoea      subjects affected / exposed 1 / 3 (33.33%) 5 / 75 (6.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 5 0 0 0 0 0 0 0 0 0 0 Productive cough      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 8 2 0 5 0 2 2 0 3 0 0 Oropharyngeal pain      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 2 0 0 0 0 3 0 0 0 0 0 Wheezing      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 2 0 1 0 0 4 0 0 Psychiatric disorders Agitation      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 1 2 1 0 0 0 0 0 1 0 1 Anxiety      subjects affected / exposed 1 / 3 (33.33%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 1 0 0 2 0 0 1 0 3 0 0 Confusional state      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 2 / 8 (25.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 2 6 0 1 0 0 1 0 0 Insomnia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 3 / 25 (12.00%) 2 / 8 (25.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 2 / 3 (66.67%)      occurrences all number 0 6 2 0 0 0 2 5 2 2 0 2 Investigations Aspartate aminotransferase increased      subjects affected / exposed 0 / 3 (0.00%) 11 / 75 (14.67%) 5 / 20 (25.00%) 1 / 8 (12.50%) 7 / 71 (9.86%) 0 / 2 (0.00%) 4 / 25 (16.00%) 4 / 25 (16.00%) 1 / 8 (12.50%) 6 / 21 (28.57%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 29 6 1 10 0 6 7 2 7 1 0 Alanine aminotransferase increased      subjects affected / exposed 0 / 3 (0.00%) 11 / 75 (14.67%) 5 / 20 (25.00%) 0 / 8 (0.00%) 6 / 71 (8.45%) 0 / 2 (0.00%) 3 / 25 (12.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 3 / 21 (14.29%) 2 / 7 (28.57%) 0 / 3 (0.00%)      occurrences all number 0 21 7 0 9 0 3 2 2 3 2 0 Activated partial thromboplastin time prolonged      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 0 1 0 0 0 0 3 0 0 Blood alkaline phosphatase increased      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 2 / 20 (10.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 6 3 0 2 0 1 0 0 2 0 0 Blood creatinine increased      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 2 / 20 (10.00%) 1 / 8 (12.50%) 3 / 71 (4.23%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 2 / 8 (25.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 5 2 2 7 0 2 1 5 4 0 0 Blood lactate dehydrogenase increased      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 2 / 25 (8.00%) 4 / 25 (16.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 0 0 4 0 2 4 0 0 0 0 International normalised ratio increased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 2 2 0 0 Blood uric acid decreased      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 2 0 Blood thyroid stimulating hormone increased      subjects affected / exposed 1 / 3 (33.33%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 Lymphocyte count decreased      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 9 / 20 (45.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 7 / 25 (28.00%) 7 / 25 (28.00%) 6 / 8 (75.00%) 11 / 21 (52.38%) 1 / 7 (14.29%) 2 / 3 (66.67%)      occurrences all number 0 14 17 0 20 0 11 7 9 23 1 4 Staphylococcus test positive      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Weight decreased      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 8 0 0 0 0 0 1 0 1 0 0 Injury, poisoning and procedural complications Skin laceration      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 0 0 0 0 0 1 0 0 0 Infusion related reaction      subjects affected / exposed 1 / 3 (33.33%) 11 / 75 (14.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 16 / 71 (22.54%) 0 / 2 (0.00%) 8 / 25 (32.00%) 3 / 25 (12.00%) 3 / 8 (37.50%) 6 / 21 (28.57%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 2 16 1 0 34 0 16 4 3 26 1 0 Road traffic accident      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 Skin abrasion      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 0 0 0 0 0 1 0 0 0 Fall      subjects affected / exposed 1 / 3 (33.33%) 5 / 75 (6.67%) 2 / 20 (10.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 2 / 25 (8.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 8 2 0 9 0 11 1 0 4 0 0 Contusion      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 4 / 71 (5.63%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 5 0 0 4 0 0 1 1 0 0 0 Cardiac disorders Sinus tachycardia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 3 0 1 0 0 2 0 0 Atrioventricular block first degree      subjects affected / exposed 1 / 3 (33.33%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 Ventricular arrhythmia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Tachycardia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 2 0 1 3 0 2 0 0 4 0 0 Nervous system disorders Brain fog      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Burning sensation      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 Dizziness      subjects affected / exposed 0 / 3 (0.00%) 8 / 75 (10.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 7 / 71 (9.86%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 9 1 0 8 0 0 0 0 0 1 0 Dysarthria      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 1 0 0 Peripheral sensory neuropathy      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 2 0 0 0 0 1 2 0 0 0 0 Headache      subjects affected / exposed 2 / 3 (66.67%) 11 / 75 (14.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 13 / 71 (18.31%) 1 / 2 (50.00%) 7 / 25 (28.00%) 3 / 25 (12.00%) 2 / 8 (25.00%) 5 / 21 (23.81%) 0 / 7 (0.00%) 2 / 3 (66.67%)      occurrences all number 2 12 1 0 22 1 9 5 2 6 0 2 Seizure      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Dysgeusia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 1 0 1 0 0 0 1 1 1 0 Hypoaesthesia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 2 0 0 1 0 0 Tremor      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 2 0 1 2 0 0 1 0 Blood and lymphatic system disorders Neutropenia      subjects affected / exposed 3 / 3 (100.00%) 55 / 75 (73.33%) 6 / 20 (30.00%) 4 / 8 (50.00%) 48 / 71 (67.61%) 1 / 2 (50.00%) 18 / 25 (72.00%) 15 / 25 (60.00%) 5 / 8 (62.50%) 16 / 21 (76.19%) 5 / 7 (71.43%) 3 / 3 (100.00%)      occurrences all number 24 181 11 8 171 4 35 59 8 36 15 6 Anaemia      subjects affected / exposed 1 / 3 (33.33%) 32 / 75 (42.67%) 5 / 20 (25.00%) 5 / 8 (62.50%) 31 / 71 (43.66%) 1 / 2 (50.00%) 14 / 25 (56.00%) 11 / 25 (44.00%) 3 / 8 (37.50%) 15 / 21 (71.43%) 3 / 7 (42.86%) 3 / 3 (100.00%)      occurrences all number 1 62 5 9 50 4 25 19 4 24 4 6 Leukopenia      subjects affected / exposed 2 / 3 (66.67%) 25 / 75 (33.33%) 10 / 20 (50.00%) 2 / 8 (25.00%) 18 / 71 (25.35%) 1 / 2 (50.00%) 12 / 25 (48.00%) 12 / 25 (48.00%) 5 / 8 (62.50%) 15 / 21 (71.43%) 5 / 7 (71.43%) 3 / 3 (100.00%)      occurrences all number 11 106 20 2 64 2 27 16 10 34 19 10 Lymphopenia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 7 0 0 2 0 0 0 0 0 0 0 Febrile neutropenia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 1 0 0 0 0 0 0 0 Thrombocytopenia      subjects affected / exposed 2 / 3 (66.67%) 63 / 75 (84.00%) 16 / 20 (80.00%) 8 / 8 (100.00%) 52 / 71 (73.24%) 2 / 2 (100.00%) 19 / 25 (76.00%) 20 / 25 (80.00%) 6 / 8 (75.00%) 16 / 21 (76.19%) 6 / 7 (85.71%) 3 / 3 (100.00%)      occurrences all number 22 291 37 16 238 10 49 80 9 30 24 9 Eye disorders Vitreous floaters      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 Vision blurred      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 1 0 2 0 0 0 0 0 Periorbital oedema      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 2 2 0 0 0 0 Gastrointestinal disorders Diarrhoea      subjects affected / exposed 0 / 3 (0.00%) 13 / 75 (17.33%) 6 / 20 (30.00%) 2 / 8 (25.00%) 15 / 71 (21.13%) 0 / 2 (0.00%) 1 / 25 (4.00%) 6 / 25 (24.00%) 3 / 8 (37.50%) 4 / 21 (19.05%) 1 / 7 (14.29%) 3 / 3 (100.00%)      occurrences all number 0 16 7 2 21 0 1 6 3 5 1 3 Constipation      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 5 / 71 (7.04%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 6 0 1 5 0 0 1 1 2 0 0 Abdominal pain upper      subjects affected / exposed 1 / 3 (33.33%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 1 1 0 0 3 0 0 0 0 0 0 0 Abdominal pain      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 0 0 1 3 0 0 2 1 1 0 1 Inguinal hernia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Haemorrhoidal haemorrhage      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 1 0 Haematochezia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 1 0 0 0 Gastrooesophageal reflux disease      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 4 0 1 0 0 0 0 0 0 0 1 Dyspepsia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 1 1 0 1 0 0 0 2 0 0 1 Nausea      subjects affected / exposed 0 / 3 (0.00%) 22 / 75 (29.33%) 4 / 20 (20.00%) 1 / 8 (12.50%) 11 / 71 (15.49%) 0 / 2 (0.00%) 7 / 25 (28.00%) 5 / 25 (20.00%) 2 / 8 (25.00%) 7 / 21 (33.33%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 35 4 1 17 0 8 7 2 7 0 0 Noninfective gingivitis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Vomiting      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 2 / 20 (10.00%) 1 / 8 (12.50%) 3 / 71 (4.23%) 0 / 2 (0.00%) 3 / 25 (12.00%) 4 / 25 (16.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 6 2 2 3 0 3 4 0 4 0 1 Toothache      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Oral pain      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 1 0 1 0 1 0 Hepatobiliary disorders Hypertransaminasaemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Cholecystitis acute      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Acute hepatic failure      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Skin and subcutaneous tissue disorders Dry skin      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 2 0 0 Alopecia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 0 0 0 0 0 0 0 2 0 0 Night sweats      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Cold sweat      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 1 0 0 0 0 0 0 0 0 Erythema      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 0 0 0 0 0 1 1 0 0 Petechiae      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 2 / 8 (25.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 2 0 0 0 0 0 0 2 0 0 0 Urticaria      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 1 0 0 0 1 2 0 0 Rash      subjects affected / exposed 1 / 3 (33.33%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 2 4 0 0 4 0 1 0 0 5 1 0 Rash maculo-papular      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 2 0 0 3 0 1 0 1 0 0 1 Pruritus      subjects affected / exposed 1 / 3 (33.33%) 6 / 75 (8.00%) 1 / 20 (5.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 4 / 21 (19.05%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 2 7 1 1 3 0 7 2 1 5 0 1 Renal and urinary disorders Acute kidney injury      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 0 / 20 (0.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 3 0 1 2 0 1 0 0 0 0 0 Renal failure      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 1 0 0 0 0 0 0 0 Proteinuria      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 2 0 1 0 1 0 0 0 Haematuria      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 2 0 0 3 0 0 0 1 0 0 0 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 0 / 3 (0.00%) 5 / 75 (6.67%) 3 / 20 (15.00%) 2 / 8 (25.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 5 / 25 (20.00%) 3 / 25 (12.00%) 1 / 8 (12.50%) 4 / 21 (19.05%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 5 3 2 3 0 7 3 2 5 0 0 Back pain      subjects affected / exposed 2 / 3 (66.67%) 10 / 75 (13.33%) 4 / 20 (20.00%) 2 / 8 (25.00%) 7 / 71 (9.86%) 0 / 2 (0.00%) 7 / 25 (28.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 2 14 4 2 17 0 7 2 1 3 0 0 Muscle spasms      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 1 0 3 0 1 0 0 13 0 0 Bone pain      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 6 1 0 5 0 1 1 1 1 0 0 Chronic kidney disease-mineral and bone disorder      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Muscular weakness      subjects affected / exposed 0 / 3 (0.00%) 8 / 75 (10.67%) 2 / 20 (10.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 9 2 1 2 0 0 1 1 1 0 0 Musculoskeletal chest pain      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 4 2 0 0 0 3 1 0 4 0 0 Pain in extremity      subjects affected / exposed 0 / 3 (0.00%) 5 / 75 (6.67%) 1 / 20 (5.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 2 / 8 (25.00%) 3 / 21 (14.29%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 6 1 0 6 0 2 2 2 3 1 0 Myalgia      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 5 / 20 (25.00%) 1 / 8 (12.50%) 7 / 71 (9.86%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 2 / 8 (25.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 7 7 1 9 0 1 0 2 2 0 0 Infections and infestations Bronchiolitis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 1 0 0 0 0 0 0 2 0 0 Pneumonia      subjects affected / exposed 0 / 3 (0.00%) 13 / 75 (17.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 6 / 71 (8.45%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 15 2 0 7 0 1 1 0 3 0 0 Ear infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Device related infection      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Urinary tract infection      subjects affected / exposed 0 / 3 (0.00%) 7 / 75 (9.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 5 / 71 (7.04%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 8 0 0 5 0 1 0 0 1 0 0 Upper respiratory tract infection      subjects affected / exposed 0 / 3 (0.00%) 12 / 75 (16.00%) 2 / 20 (10.00%) 1 / 8 (12.50%) 6 / 71 (8.45%) 1 / 2 (50.00%) 2 / 25 (8.00%) 5 / 25 (20.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 1 / 7 (14.29%) 1 / 3 (33.33%)      occurrences all number 0 16 4 1 10 1 2 6 0 3 1 1 Sinusitis      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 2 / 20 (10.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 2 / 25 (8.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 2 0 0 0 2 1 0 0 0 0 Skin candida      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 Streptococcal bacteraemia      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 0 0 0 Respiratory tract infection      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 1 / 71 (1.41%) 0 / 2 (0.00%) 0 / 25 (0.00%) 1 / 25 (4.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 6 0 0 1 0 0 1 0 0 0 0 Metabolism and nutrition disorders Decreased appetite      subjects affected / exposed 0 / 3 (0.00%) 14 / 75 (18.67%) 0 / 20 (0.00%) 1 / 8 (12.50%) 8 / 71 (11.27%) 0 / 2 (0.00%) 1 / 25 (4.00%) 1 / 25 (4.00%) 1 / 8 (12.50%) 2 / 21 (9.52%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 21 0 1 10 0 1 1 1 2 0 1 Diabetes mellitus      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 Hypercalcaemia      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 3 / 71 (4.23%) 0 / 2 (0.00%) 0 / 25 (0.00%) 2 / 25 (8.00%) 1 / 8 (12.50%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 7 0 1 4 0 0 2 1 0 0 0 Hyperglycaemia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 5 / 20 (25.00%) 2 / 8 (25.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 4 / 25 (16.00%) 4 / 25 (16.00%) 5 / 8 (62.50%) 9 / 21 (42.86%) 5 / 7 (71.43%) 2 / 3 (66.67%)      occurrences all number 0 1 12 2 0 0 5 4 5 24 7 6 Hyperkalaemia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 2 0 0 0 1 3 0 0 0 0 Hypokalaemia      subjects affected / exposed 0 / 3 (0.00%) 9 / 75 (12.00%) 4 / 20 (20.00%) 2 / 8 (25.00%) 6 / 71 (8.45%) 0 / 2 (0.00%) 4 / 25 (16.00%) 5 / 25 (20.00%) 1 / 8 (12.50%) 2 / 21 (9.52%) 1 / 7 (14.29%) 1 / 3 (33.33%)      occurrences all number 0 17 5 2 9 0 4 5 2 5 1 3 Hypoglycaemia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 1 / 20 (5.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 1 / 8 (12.50%) 1 / 21 (4.76%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 1 1 0 0 0 1 0 1 1 1 0 Hypocalcaemia      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 4 / 20 (20.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 9 / 25 (36.00%) 2 / 25 (8.00%) 4 / 8 (50.00%) 5 / 21 (23.81%) 1 / 7 (14.29%) 0 / 3 (0.00%)      occurrences all number 0 13 5 1 7 0 9 3 6 10 1 0 Hyperphosphataemia      subjects affected / exposed 0 / 3 (0.00%) 1 / 75 (1.33%) 0 / 20 (0.00%) 0 / 8 (0.00%) 0 / 71 (0.00%) 0 / 2 (0.00%) 2 / 25 (8.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 0 / 21 (0.00%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 1 0 0 0 0 2 0 0 0 0 0 Hyperuricaemia      subjects affected / exposed 0 / 3 (0.00%) 3 / 75 (4.00%) 1 / 20 (5.00%) 1 / 8 (12.50%) 1 / 71 (1.41%) 0 / 2 (0.00%) 1 / 25 (4.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 3 / 21 (14.29%) 1 / 7 (14.29%) 1 / 3 (33.33%)      occurrences all number 0 5 1 1 1 0 1 0 0 5 1 2 Hypomagnesaemia      subjects affected / exposed 0 / 3 (0.00%) 6 / 75 (8.00%) 3 / 20 (15.00%) 0 / 8 (0.00%) 3 / 71 (4.23%) 0 / 2 (0.00%) 2 / 25 (8.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 4 / 21 (19.05%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 8 3 0 3 0 2 2 0 5 0 1 Hypoalbuminaemia      subjects affected / exposed 0 / 3 (0.00%) 2 / 75 (2.67%) 8 / 20 (40.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 3 / 25 (12.00%) 4 / 25 (16.00%) 1 / 8 (12.50%) 6 / 21 (28.57%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 3 12 1 5 0 3 5 2 8 0 0 Metabolic acidosis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 2 0 0 0 0 1 0 0 Lactic acidosis      subjects affected / exposed 0 / 3 (0.00%) 0 / 75 (0.00%) 0 / 20 (0.00%) 1 / 8 (12.50%) 0 / 71 (0.00%) 0 / 2 (0.00%) 0 / 25 (0.00%) 0 / 25 (0.00%) 0 / 8 (0.00%) 1 / 21 (4.76%) 0 / 7 (0.00%) 0 / 3 (0.00%)      occurrences all number 0 0 0 1 0 0 0 0 0 1 0 0 Hypophosphataemia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 2 / 20 (10.00%) 1 / 8 (12.50%) 2 / 71 (2.82%) 0 / 2 (0.00%) 8 / 25 (32.00%) 2 / 25 (8.00%) 0 / 8 (0.00%) 2 / 21 (9.52%) 0 / 7 (0.00%) 1 / 3 (33.33%)      occurrences all number 0 5 4 1 2 0 10 2 0 3 0 2 Hyponatraemia      subjects affected / exposed 0 / 3 (0.00%) 4 / 75 (5.33%) 6 / 20 (30.00%) 4 / 8 (50.00%) 2 / 71 (2.82%) 0 / 2 (0.00%) 4 / 25 (16.00%) 3 / 25 (12.00%) 1 / 8 (12.50%) 3 / 21 (14.29%) 1 / 7 (14.29%) 1 / 3 (33.33%)      occurrences all number 0 4 11 5 5 0 4 3 1 3 1 1

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
05 Apr 2017	The following changes were made as per Amendment 01: 1. The compound name was updated to TAK-573 and the study number was updated accordingly. 2. The number of participants for phase 1 and 2a were revised. 3. The definitions of PK, biomarker, and pharmacodynamic measurements were updated.
07 Nov 2017	The following changes were made as per Amendment 02: 1. Changed at time of “enrollment” and “randomization” to “first dose.” 2. Modified triplicate ECG measurement time points.
29 Jun 2018	The following changes were made as per Amendment 03: 1. Removed test dose. 2. Reduced number of dose escalation levels to remove possible subtherapeutic doses. 3. Removed baseline visit (Day -1) associated with test dose administration. 4. Added the possibility of defining an optimal biologic dose (OBD) on the basis of pharmacodynamic endpoints as an alternative to the maximum tolerated dose (MTD) based on DLTs as a possible dose for future studies. 4. Revised PK sample collection schedule. 5. Changed the ECOG performance status requirement from 0-2 to 0-1.
22 Oct 2018	The following changes were made as per Amendment 04: 1. Added 3 schedules (Schedule B, C and D) to the original schedule (Schedule A) to be evaluated during the dose escalation phase. 2. Modified hematologic TEAEs to be considered DLTs. 3. Added subsequent anticancer therapy to AE and SAE reporting timelines. 4. Added option for eligible participants for intra-participants dose escalation to continue in a different schedule.
03 Jul 2019	The following changes were made as per Amendment 05: 1. Reduced the infusion time for modakafusp alfa. 2. Removed the requirement for preinfusion and postinfusion medication. 3. Added combination cohort(s) with dexamethasone during the phase 2 expansion phase. 4. Updated the expected number of cohorts and patients for phase 2. 5. Changed phase 2a to phase 2 throughout. 6. Replaced “monotherapy” with “single agent” throughout. 7. Added “relapsed” to the description of the study population. 8. Added a Clinical Safety section. 9. Added a definition of “DLT-like.” 10. Increased the frequency of PFS follow-up to 4 weeks for participants who discontinued for reasons other than PD. 11. Updated inclusion criterion for females of childbearing potential and male participants. 12. Added guidance regarding discontinuation of dexamethasone for the combination arm. 13. Revised the end-of-study description. 13. Added a Posttrial Access section. 14. Revised exclusion criterion regarding severe allergic or anaphylactic reactions.
16 Oct 2020	The following changes were made as per Amendment 06: 1. Added new safety data. 2. Added CBR and DCR as a secondary endpoint for phase 1 and a primary endpoint for phase 2, respectively. 3. Removed OS as a secondary endpoint. 4. Updated the number of study sites and expected study duration. 4. Defined IRRs and treatment of IRRs. 5. Added oxygen saturation to vital signs. 6. Defined AESIs. 7. Added response-evaluable analysis set. 8. Revised the planned sample size for phase 2.
01 Mar 2022	The following changes were made as per Amendment 08: 1. Increased the number of planned study sites to 100. 2. Revised eligibility criteria regarding disease characteristics required for Part 3. 3. Added a second interim analysis for Part 3. 4. Removed CR as a reason for discontinuation (already covered under “other”). 5. Updated study monitoring guidelines to allow for COVID-19 circumstances.
02 Aug 2023	The following changes were made as per Amendment 09: 1. The IND No. and Abbreviated European Union Drug Regulating Authorities Clinical Trials (EUDRACT) number were added to the cover page. 2. “Immunogenicity” was added to description of assessments. 3. The purpose, enrollment plan, and number of participants for the China cohort were described. 4. Serum creatinine was removed as an inclusion criterion. 5. Participants may be treated after disease progression if the investigator considers it in the best interest of the participants and with approval by the sponsor. 6. Evaluation of neutralizing antibodies was added to ADA assessments and endpoints in Parts 1 and 2. 7. Intensive pharmacokinetic (PK) sampling endpoints for the China cohort were added to Part 3 Secondary Objectives and Part 3 Secondary Endpoints, along with a corresponding PK table in the appendix. 8. The exclusion criterion for hepatitis infection was revised; hepatitis testing for the Japan safety lead-in Part 3 was added. 9. Previous treatment with modakafusp alfa was added as an exclusion criterion. 10. Procedures for reporting SAEs were updated. 11. IMWG criteria were updated to 2016 version.
03 Apr 2024	The following changes were made as per Amendment 10: 1. Implemented new dose modification guidelines in cases of bleeding treatment-emergent adverse events (TEAEs) as an urgent safety measure. 2. Changed the Primary Objective and Endpoint for the Part 3 Dose Extension part of the study to investigator-assessed ORR.
Interruptions (globally)
Were there any global interruptions to the trial? Yes
Date Interruption Restart date 07 Nov 2024 The study was terminated by the sponsor for strategic reasons. -
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
The study was terminated early due to discontinuation of development of modakafusp alfa for strategic reasons. The February 9 2024 data cut comprises the final full dataset for safety and efficacy.

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