Trial Outcomes & Findings for Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) (NCT NCT03340883)

NCT ID: NCT03340883

Last Updated: 2021-04-01

Results Overview

Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 28 days following first administration of BION-1301
• Results posted on: 2021-04-01

Participant Flow

Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.

Participant milestones

Measure	BION-1301 50 mg Q2W 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
Overall Study STARTED	4	3	4	4	3	3
Overall Study COMPLETED	4	3	4	4	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)

Baseline characteristics by cohort

Measure	Phase 1 BION-1301 n=21 Participants BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. BION-1301: a solution for intravenous (IV) administration, diluted and administered Q2W
Age, Customized <65 years	6 Participants n=5 Participants
Age, Customized >=65 years	15 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days following first administration of BION-1301

Population: Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.

Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent

Outcome measures

Measure	BION-1301 50 mg Q2W n=4 Participants 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W n=3 Participants 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W n=4 Participants 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W n=4 Participants 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W n=3 Participants 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W n=3 Participants 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
Safety (Phase 1)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Approximately 2 years

Population: Study was terminated early. No outcome measures were assessed.

Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and approximately 2 years

Population: Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported.

Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)

Outcome measures

Measure	BION-1301 50 mg Q2W n=4 Participants 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W n=3 Participants 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W n=4 Participants 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W n=4 Participants 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W n=3 Participants 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W n=3 Participants 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
Biomarkers (Phase 1 and 2) Free APRIL target engagement (AUEC1-15d)	1000 % change relative to baseline Interval 580.0 to 1500.0	970 % change relative to baseline Interval 750.0 to 1200.0	470 % change relative to baseline Interval 190.0 to 620.0	140 % change relative to baseline Interval 79.0 to 510.0	72 % change relative to baseline Interval 70.0 to 250.0	200 % change relative to baseline Interval 56.0 to 240.0

PRIMARY outcome

Timeframe: Baseline and approximately 2 years

Population: Some laboratory tests were not performed for some of the participants. Therefore, the number analyzed does not always match the overall number of participants analyzed. Study was terminated early and Phase 2 did not enroll.

Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline

Outcome measures

Measure	BION-1301 50 mg Q2W n=4 Participants 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W n=3 Participants 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W n=4 Participants 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W n=4 Participants 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W n=3 Participants 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W n=3 Participants 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
Bioanalytical Measures (Phase 1 and Phase 2) Urine Protein, Calculated (mg/24hr)	—	—	9.1743 percentage change Interval 9.1743 to 9.1743	—	42.9298 percentage change Interval 15.0943 to 70.7652	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Alpha-2 Globulin (g/dL)	2.985 percentage change Interval 2.439 to 20.408	31.579 percentage change Interval 31.579 to 31.579	14.286 percentage change Interval 13.415 to 14.754	10.843 percentage change Interval 9.756 to 12.037	14.286 percentage change Interval 14.286 to 14.286	10.000 percentage change Interval 4.918 to 33.333
Bioanalytical Measures (Phase 1 and Phase 2) Serum Beta Globulin (g/dL)	33.636 percentage change Interval 33.636 to 33.636	3.125 percentage change Interval 3.125 to 3.125	0.542 percentage change Interval 0.542 to 0.542	22.472 percentage change Interval 22.472 to 22.472	8.571 percentage change Interval 7.143 to 10.0	2.609 percentage change Interval 2.609 to 2.609
Bioanalytical Measures (Phase 1 and Phase 2) Serum Gamma Globulin (g/dL)	13.920 percentage change Interval 8.511 to 41.667	96.552 percentage change Interval 96.552 to 96.552	25.926 percentage change Interval 15.789 to 50.0	23.441 percentage change Interval 22.807 to 24.074	0.627 percentage change Interval 0.627 to 0.627	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Immunoglobulin A (g/L)	1.615 percentage change Interval 1.615 to 1.615	66.667 percentage change Interval 66.667 to 66.667	36.174 percentage change Interval 0.717 to 71.631	30.536 percentage change Interval 12.5 to 48.571	23.077 percentage change Interval 16.667 to 70.588	23.077 percentage change Interval 23.077 to 23.077
Bioanalytical Measures (Phase 1 and Phase 2) Serum Immunoglobulin G (g/L)	25.274 percentage change Interval 8.312 to 42.236	25.000 percentage change Interval 16.788 to 33.212	25.016 percentage change Interval 22.566 to 27.467	20.125 percentage change Interval 14.888 to 25.362	—	0.352 percentage change Interval 0.352 to 0.352
Bioanalytical Measures (Phase 1 and Phase 2) Serum Immunoglobulin M (g/L)	27.273 percentage change Interval 27.273 to 76.563	28.571 percentage change Interval 14.286 to 40.0	40.000 percentage change Interval 40.0 to 40.0	61.364 percentage change Interval 54.545 to 68.182	64.148 percentage change Interval 46.154 to 82.143	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Kappa Light Chain, Free (mg/dL)	34.0000 percentage change Interval 6.7568 to 46.4419	5.9735 percentage change Interval 5.9735 to 5.9735	42.0349 percentage change Interval 30.0 to 54.0698	72.4863 percentage change Interval 69.3627 to 75.6098	64.8649 percentage change Interval 64.8649 to 64.8649	47.9787 percentage change Interval 30.0 to 65.9574
Bioanalytical Measures (Phase 1 and Phase 2) Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO)	53.919 percentage change Interval 50.0 to 57.838	—	50.000 percentage change Interval 50.0 to 50.0	100.000 percentage change Interval 100.0 to 100.0	60.000 percentage change Interval 60.0 to 60.0	100.000 percentage change Interval 100.0 to 100.0
Bioanalytical Measures (Phase 1 and Phase 2) Serum Lambda Light Chain, Free (mg/dL)	13.9651 percentage change Interval 7.0 to 20.9302	26.3520 percentage change Interval 11.1111 to 41.5929	13.4372 percentage change Interval 13.4028 to 57.6642	26.9335 percentage change Interval 12.5 to 41.3669	24.5619 percentage change Interval 20.0 to 29.1237	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Monoclonal Protein Spike (g/dL)	13.1579 percentage change Interval 1.0526 to 50.0	—	5.4670 percentage change Interval 5.467 to 5.467	27.2727 percentage change Interval 27.2727 to 27.2727	—	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Protein (g/dL)	8.14 percentage change Interval 8.14 to 8.14	—	3.06 percentage change Interval 2.88 to 3.23	3.03 percentage change Interval 3.03 to 3.03	6.74 percentage change Interval 6.74 to 6.74	3.05 percentage change Interval 1.69 to 4.41
Bioanalytical Measures (Phase 1 and Phase 2) Urine Albumin (mg/dL)	—	18.1818 percentage change Interval 18.1818 to 18.1818	—	—	54.7349 percentage change Interval 20.6055 to 88.8643	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum A/G Ratio (RATIO)	24.763 percentage change Interval 18.182 to 31.343	31.538 percentage change Interval 23.077 to 40.0	28.571 percentage change Interval 28.571 to 28.571	—	20.202 percentage change Interval 18.182 to 22.222	—
Bioanalytical Measures (Phase 1 and Phase 2) Serum Albumin (g/dL)	40.191 percentage change Interval 27.326 to 53.056	5.405 percentage change Interval 5.217 to 28.0	10.591 percentage change Interval 6.897 to 14.286	9.294 percentage change Interval 3.808 to 17.042	3.571 percentage change Interval 2.778 to 13.587	7.979 percentage change Interval 7.979 to 7.979
Bioanalytical Measures (Phase 1 and Phase 2) Serum Alpha-1 Globulin (g/dL)	18.698 percentage change Interval 14.815 to 22.581	30.556 percentage change Interval 30.556 to 30.556	29.710 percentage change Interval 26.087 to 33.333	24.138 percentage change Interval 24.138 to 24.138	16.129 percentage change Interval 16.129 to 16.129	20.000 percentage change Interval 18.919 to 50.0
Bioanalytical Measures (Phase 1 and Phase 2) Urine Alpha-1 Globulin (mg/dL)	—	80.0000 percentage change Interval 80.0 to 80.0	—	—	71.7418 percentage change Interval 60.4982 to 82.9854	—
Bioanalytical Measures (Phase 1 and Phase 2) Urine Alpha-2 Globulin (mg/dL)	—	—	—	—	63.5621 percentage change Interval 37.2727 to 89.8515	—
Bioanalytical Measures (Phase 1 and Phase 2) Urine Beta Globulin (mg/dL)	—	—	—	19.4996 percentage change Interval 19.4996 to 19.4996	49.3411 percentage change Interval 6.6748 to 92.0074	—
Bioanalytical Measures (Phase 1 and Phase 2) Urine Gamma Globulin (mg/dL)	—	90.3185 percentage change Interval 90.3185 to 90.3185	100.0000 percentage change Interval 100.0 to 100.0	—	93.1735 percentage change Interval 93.1735 to 93.1735	—
Bioanalytical Measures (Phase 1 and Phase 2) Urine Monoclonal Protein Spike (%)	—	—	—	2.755 percentage change Interval 2.755 to 2.755	30.695 percentage change Interval 30.695 to 30.695	11.819 percentage change Interval 11.819 to 11.819
Bioanalytical Measures (Phase 1 and Phase 2) Urine Protein (mg/dL)	—	—	—	—	52.9665 percentage change Interval 14.2857 to 91.6472	—

PRIMARY outcome

Timeframe: 28 days

Population: Study was terminated early and Phase 2 was not enrolled. Safety profile was not assessed.

BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Approximately 30 months

Population: Study was terminated early and Phase 2 was not enrolled. Objective response rate was not assessed.

Objective response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Approximately 30 months

Population: Study was terminated early and Phase 2 did not enroll. Progression-free survival was not assessed.

Progression-free survival (PFS) defined as time from first dose of study drug to date of first tumor progression or death due to any cause

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Approximately 30 months

Population: Study was terminated early and Phase 2 did not enroll. Overall survival was not assessed.

Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause

Outcome measures

Outcome data not reported

Adverse Events

BION-1301 50 mg Q2W

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

BION-1301 150 mg Q2W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

BION-1301 450 mg Q2W

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

BION-1301 1350 mg Q2W

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

BION-1301 2700 mg Q2W

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

BION-1301 1350 mg QW*8W->Q2W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	BION-1301 50 mg Q2W n=4 participants at risk 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W n=3 participants at risk 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W n=4 participants at risk 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W n=4 participants at risk 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W n=3 participants at risk 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W n=3 participants at risk 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
General disorders Asthenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Sudden death	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Lung infection	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Staphylococcal sepsis	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Renal failure	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Disease progression	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.

Other adverse events

Measure	BION-1301 50 mg Q2W n=4 participants at risk 50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.	BION-1301 150 mg Q2W n=3 participants at risk 150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 450 mg Q2W n=4 participants at risk 450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg Q2W n=4 participants at risk 1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 2700 mg Q2W n=3 participants at risk 2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.	BION-1301 1350 mg QW*8W->Q2W n=3 participants at risk 1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
Psychiatric disorders Insomnia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Constipation	75.0% 3/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Nausea	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Gastrointestinal disorders Vomiting	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Fatigue	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	75.0% 3/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Pyrexia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Chills	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Localised oedema	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Non-cardiac chest pain	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
General disorders Oedema peripheral	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	66.7% 2/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Bone pain	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Muscular weakness	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypercalcaemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	66.7% 2/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hyperuricaemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Metabolism and nutrition disorders Hypokalaemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Conjunctivitis	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Hordeolum	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Pneumonia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Rhinovirus infection	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Infections and infestations Urinary tract infection	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Haematuria	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Incontinence	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Renal and urinary disorders Proteinuria	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Vascular disorders Hypertension	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Vascular disorders Hypotension	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Vascular disorders Haematoma	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Nervous system disorders Dysgeusia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Nervous system disorders Dizziness	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Nervous system disorders Muscle spasticity	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Eye disorders Diplopia	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Eye disorders Vision blurred	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	33.3% 1/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Investigations Blood creatinine increased	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	50.0% 2/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Investigations Blood fibrinogen decreased	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.
Investigations International normalised ratio increased	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	25.0% 1/4 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.	0.00% 0/3 • From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.

Additional Information

Chinook Therapeutics, Inc. (formerly Aduro Biotech, Inc.)

Chinook Therapeutics, Inc.

Phone: 206-485-7051

Email: clinicaltrials@chinooktx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Disclosure restriction - study results first published in a joint multi-center paper unless (a) no multi-center publication, or (b) ≥18 months has passed since completion of the study. Thereafter, Investigator may publish provided that Investigator: (i) provides a copy of the publication to Aduro ≥ 60 days in advance of submission for publication; (ii) deletes Aduro Confidential Information (other than the Study results) and (iii) submission may be delayed up to 90 days to permit IP filings.
• Publication restrictions are in place

Restriction type: OTHER