Trial Outcomes & Findings for A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 (NCT NCT04828161)

Last Updated: 2026-01-27

Results Overview

The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

407 participants

Primary outcome timeframe

Baseline (Day 1) and Days 3, 5 and 8

Results posted on

2026-01-27

Participant Flow

This study consisted of 2 parts, Part A and Part B. The Part A was Phase II proof of efficacy study conducted in ambulatory adult participants with symptomatic coronavirus disease 2019 (COVID-19) at 45 centers across 5 countries (Hungary, India, Netherlands, South Africa, and USA) between 10 May 2021 and 27 Jan 2022. The Part B was to be a Phase III confirmatory study. Only Part A analysis is reported since Part B of the study was not initiated.

The Part A of the study consisted of a screening period (up to 3 days) followed by study treatment on Day 1. Participants were randomized in 1:1:1:1 ratio, stratified by risk for COVID-19 disease progression, to receive 1 of 4 study treatments (Ensovibep 600 mg or Ensovibep 225 mg or Ensovibep 75 mg or Placebo). A total of 407 participants were randomized in the study, of which 400 were treated.

Participant milestones

Participant milestones
Measure	Ensovibep 600 mg Participants received single intravenous (IV) infusion of ensovibep 600 milligram (mg) on Day 1.	Ensovibep 225 mg Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Overall Study STARTED	100	102	103	102
Overall Study COMPLETED	97	95	96	94
Overall Study NOT COMPLETED	3	7	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Ensovibep 600 mg Participants received single intravenous (IV) infusion of ensovibep 600 milligram (mg) on Day 1.	Ensovibep 225 mg Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Overall Study Withdrawal by Subject	0	3	3	4
Overall Study Lost to Follow-up	1	4	2	2
Overall Study Other	2	0	2	0
Overall Study Death	0	0	0	2

Baseline Characteristics

A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ensovibep 600 mg n=100 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=100 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=101 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo n=99 Participants Participants received single IV infusion of placebo matching with ensovibep on Day 1.	Total n=400 Participants Total of all reporting groups
Race/Ethnicity, Customized Multiple	5 Participants n=25 Participants	4 Participants n=25 Participants	6 Participants n=50 Participants	8 Participants n=152 Participants	23 Participants n=614 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 11.50 • n=25 Participants	40.2 years STANDARD_DEVIATION 12.90 • n=25 Participants	41.5 years STANDARD_DEVIATION 12.84 • n=50 Participants	42.3 years STANDARD_DEVIATION 13.75 • n=152 Participants	41.1 years STANDARD_DEVIATION 12.75 • n=614 Participants
Sex: Female, Male Female	47 Participants n=25 Participants	54 Participants n=25 Participants	60 Participants n=50 Participants	57 Participants n=152 Participants	218 Participants n=614 Participants
Sex: Female, Male Male	53 Participants n=25 Participants	46 Participants n=25 Participants	41 Participants n=50 Participants	42 Participants n=152 Participants	182 Participants n=614 Participants
Race/Ethnicity, Customized White	59 Participants n=25 Participants	63 Participants n=25 Participants	62 Participants n=50 Participants	63 Participants n=152 Participants	247 Participants n=614 Participants
Race/Ethnicity, Customized Asian	14 Participants n=25 Participants	14 Participants n=25 Participants	13 Participants n=50 Participants	16 Participants n=152 Participants	57 Participants n=614 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=25 Participants	11 Participants n=25 Participants	14 Participants n=50 Participants	11 Participants n=152 Participants	52 Participants n=614 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=25 Participants	4 Participants n=25 Participants	3 Participants n=50 Participants	1 Participants n=152 Participants	9 Participants n=614 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=25 Participants	1 Participants n=25 Participants	2 Participants n=50 Participants	0 Participants n=152 Participants	4 Participants n=614 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants	0 Participants n=152 Participants	4 Participants n=614 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=25 Participants	3 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants	4 Participants n=614 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Days 3, 5 and 8

Population: The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=89 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=97 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=97 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo n=87 Participants Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8	-1.99 log10 copies/milliliter (mL) Standard Error 0.097	-1.73 log10 copies/milliliter (mL) Standard Error 0.093	-1.81 log10 copies/milliliter (mL) Standard Error 0.093	-1.40 log10 copies/milliliter (mL) Standard Error 0.098

PRIMARY outcome

Timeframe: Up to Day 29

Population: The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.

Percentage of participants experiencing hospitalizations \[\>= 24 hour (h) of acute care\] and/or ER visits related to COVID-19 or death from any cause up to Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 29

Population: The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered.

Percentage of participants experiencing hospitalizations (\>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=100 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=100 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=101 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo n=99 Participants Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause Death from any cause	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.0 percentage of participants
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause Any event	1.0 percentage of participants	3.0 percentage of participants	0.0 percentage of participants	6.1 percentage of participants
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause Hospitalizations (≥ 24 h of acute care)	0.0 percentage of participants	2.0 percentage of participants	0.0 percentage of participants	5.1 percentage of participants
Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause Emergency room visits related to COVID-19	1.0 percentage of participants	1.0 percentage of participants	0.0 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Up to Day 29

Population: The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.

Sustained clinical recovery was defined as follows; 1. All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and 2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=63 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=66 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=74 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo n=70 Participants Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Time to Sustained Clinical Recovery	23.0 days Interval 14.0 to 29.0	15.0 days Interval 13.0 to 21.0	14.0 days Interval 11.0 to 28.0	29.0 days Interval 21.0 to 32.0

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Population: The Pharmacokinetic (PK) analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.

Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=94 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=92 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=95 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep Total Ensovibep	187 microgram (mcg) per mL Geometric Coefficient of Variation 25.3	70.4 microgram (mcg) per mL Geometric Coefficient of Variation 27.5	25.1 microgram (mcg) per mL Geometric Coefficient of Variation 38.4	—
Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep Free Ensovibep	210 microgram (mcg) per mL Geometric Coefficient of Variation 26.3	78.1 microgram (mcg) per mL Geometric Coefficient of Variation 31.5	29.3 microgram (mcg) per mL Geometric Coefficient of Variation 46.4	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Population: The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.

Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=94 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=91 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=95 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep Free Ensovibep	68200 h*mcg/mL Geometric Coefficient of Variation 84.4	22500 h*mcg/mL Geometric Coefficient of Variation 126.9	8380 h*mcg/mL Geometric Coefficient of Variation 67.9	—
Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep Total Ensovibep	63300 h*mcg/mL Geometric Coefficient of Variation 87.6	21100 h*mcg/mL Geometric Coefficient of Variation 122.0	7950 h*mcg/mL Geometric Coefficient of Variation 67.1	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3

Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=95 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=90 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=95 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep Total Ensovibep	7520 h*mcg/mL Geometric Coefficient of Variation 35.3	2830 h*mcg/mL Geometric Coefficient of Variation 35.7	999 h*mcg/mL Geometric Coefficient of Variation 34.4	—
Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep Free Ensovibep	8290 h*mcg/mL Geometric Coefficient of Variation 32.1	2800 h*mcg/mL Geometric Coefficient of Variation 156.2	1120 h*mcg/mL Geometric Coefficient of Variation 36.7	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8

Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=95 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=89 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=95 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep Total Ensovibep	23000 h*mcg/mL Geometric Coefficient of Variation 23.7	8570 h*mcg/mL Geometric Coefficient of Variation 33.1	3020 h*mcg/mL Geometric Coefficient of Variation 31.4	—
Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep Free Ensovibep	25200 h*mcg/mL Geometric Coefficient of Variation 23.2	8940 h*mcg/mL Geometric Coefficient of Variation 73.2	3390 h*mcg/mL Geometric Coefficient of Variation 35.3	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15

Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=95 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=88 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=94 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep Total Ensovibep	38200 h*mcg/mL Geometric Coefficient of Variation 23.2	13800 h*mcg/mL Geometric Coefficient of Variation 37.6	5040 h*mcg/mL Geometric Coefficient of Variation 31.9	—
Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep Free Ensovibep	41800 h*mcg/mL Geometric Coefficient of Variation 23.5	15300 h*mcg/mL Geometric Coefficient of Variation 41.6	5620 h*mcg/mL Geometric Coefficient of Variation 39.1	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=87 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=82 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=82 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep Total Ensovibep	75400 h*mcg/mL Geometric Coefficient of Variation 33.5	27600 h*mcg/mL Geometric Coefficient of Variation 36.3	9930 h*mcg/mL Geometric Coefficient of Variation 41.0	—
Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep Free Ensovibep	80100 h*mcg/mL Geometric Coefficient of Variation 40.6	29400 h*mcg/mL Geometric Coefficient of Variation 34.8	9540 h*mcg/mL Geometric Coefficient of Variation 45.8	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=95 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=92 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=95 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep Free Ensovibep	1.01 hour Geometric Coefficient of Variation 473.8	1.09 hour Geometric Coefficient of Variation 516.6	1.24 hour Geometric Coefficient of Variation 810.1	—
Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep Total Ensovibep	0.935 hour Geometric Coefficient of Variation 457.5	1.30 hour Geometric Coefficient of Variation 693.5	1.05 hour Geometric Coefficient of Variation 573.6	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=84 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=80 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=74 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep Total Ensovibep	8.07 mL/h Geometric Coefficient of Variation 35.4	8.11 mL/h Geometric Coefficient of Variation 36.1	7.48 mL/h Geometric Coefficient of Variation 42.1	—
Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep Free Ensovibep	7.55 mL/h Geometric Coefficient of Variation 37.3	7.64 mL/h Geometric Coefficient of Variation 35.3	7.78 mL/h Geometric Coefficient of Variation 43.0	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=84 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=79 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=74 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep Total Ensovibep	0.003 per hour Geometric Coefficient of Variation 52.1	0.002 per hour Geometric Coefficient of Variation 50.6	0.002 per hour Geometric Coefficient of Variation 39.5	—
Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep Free Ensovibep	0.003 per hour Geometric Coefficient of Variation 69.6	0.003 per hour Geometric Coefficient of Variation 48.3	0.003 per hour Geometric Coefficient of Variation 61.2	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=90 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=83 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=83 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep Free Ensovibep	262 hour Geometric Coefficient of Variation 67.7	234 hour Geometric Coefficient of Variation 48.3	215 hour Geometric Coefficient of Variation 60.6	—
Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep Total Ensovibep	274 hour Geometric Coefficient of Variation 54.0	290 hour Geometric Coefficient of Variation 53.8	309 hour Geometric Coefficient of Variation 39.8	—

SECONDARY outcome

Timeframe: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91

Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.

Outcome measures

Outcome measures
Measure	Ensovibep 600 mg n=84 Participants Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=80 Participants Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=74 Participants Participants received single IV infusion of ensovibep 75 mg on Day 1.	Placebo Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep Total Ensovibep	3230 mL Geometric Coefficient of Variation 35.0	3310 mL Geometric Coefficient of Variation 37.5	3330 mL Geometric Coefficient of Variation 38.7	—
Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep Free Ensovibep	2760 mL Geometric Coefficient of Variation 46.1	2590 mL Geometric Coefficient of Variation 36.4	2470 mL Geometric Coefficient of Variation 45.6	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Days 3, 5 and 8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 29

Sustained clinical recovery was defined as follows; 1. All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and 2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep

Treatment-emergent ADA is defined as any participant with a 1. 2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or, 2. 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).

Outcome measures

Outcome data not reported

Adverse Events

Ensovibep 600 mg

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Ensovibep 225 mg

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Ensovibep 75 mg

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Ensovibep Total

Serious events: 3 serious events

Other events: 131 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 53 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Ensovibep 600 mg n=100 participants at risk Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=98 participants at risk Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=102 participants at risk Participants received single IV infusion of ensovibep 75 mg on Day 1.	Ensovibep Total n=300 participants at risk Participants received single IV infusion of ensovibep on Day 1.	Placebo n=100 participants at risk Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Cardiac disorders Angina pectoris	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Cardiac disorders Cor pulmonale	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Hiatus hernia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations COVID-19	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations COVID-19 pneumonia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	4.0% 4/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Sepsis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Septic shock	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Paranasal sinus inflammation	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.

Other adverse events

Other adverse events
Measure	Ensovibep 600 mg n=100 participants at risk Participants received single IV infusion of ensovibep 600 mg on Day 1.	Ensovibep 225 mg n=98 participants at risk Participants received single IV infusion of ensovibep 225 mg on Day 1.	Ensovibep 75 mg n=102 participants at risk Participants received single IV infusion of ensovibep 75 mg on Day 1.	Ensovibep Total n=300 participants at risk Participants received single IV infusion of ensovibep on Day 1.	Placebo n=100 participants at risk Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Constipation	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Leukopenia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Diarrhoea	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Lymphadenopathy	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Neutropenia	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.9% 4/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.7% 8/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Eye disorders Abnormal sensation in eye	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Eye disorders Disorder of globe	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Eye disorders Uveitis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Eye disorders Vision blurred	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Abdominal pain	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Dyspepsia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Eosinophilia	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.9% 3/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Haemorrhoids	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Nausea	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.3% 4/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Pancreatitis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Gastrointestinal disorders Vomiting	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 6/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Adverse drug reaction	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Asthenia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Fatigue	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Infusion site haematoma	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Infusion site swelling	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Non-cardiac chest pain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Pain	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Pyrexia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Swelling face	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
General disorders Vessel puncture site haematoma	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Hepatobiliary disorders Nonalcoholic fatty liver disease	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Immune system disorders Allergy to chemicals	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Bronchitis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations COVID-19	6.0% 6/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.0% 9/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	4.0% 4/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations COVID-19 pneumonia	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.3% 4/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Cystitis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Eye infection bacterial	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Gastroenteritis	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Genital infection fungal	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Nasopharyngitis	5.0% 5/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.9% 3/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.0% 9/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	5.0% 5/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Oral candidiasis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Otitis media	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Pancreatitis viral	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Pharyngitis bacterial	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Pneumonia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Pyelonephritis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Sinusitis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Sinusitis bacterial	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Upper respiratory tract infection	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Infections and infestations Urinary tract infection	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Fall	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Activated partial thromboplastin time prolonged	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.7% 5/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Alanine aminotransferase increased	7.0% 7/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.1% 3/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.7% 11/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Amylase increased	4.0% 4/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 6/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Aspartate aminotransferase increased	6.0% 6/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.1% 3/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.3% 10/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood alkaline phosphatase increased	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood bilirubin increased	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.3% 4/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood creatine phosphokinase increased	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.7% 5/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood creatinine increased	6.0% 6/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	4.1% 4/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.9% 3/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	4.3% 13/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	6.0% 6/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood glucose increased	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood lactate dehydrogenase increased	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood phosphorus decreased	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood pressure increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood sodium decreased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood sodium increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Blood uric acid increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.1% 3/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.3% 4/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations C-reactive protein increased	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Fibrin D dimer increased	5.0% 5/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.9% 4/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.7% 11/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Gamma-glutamyltransferase increased	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.9% 3/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.3% 7/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Haematocrit decreased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Haemoglobin decreased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Hepatic enzyme increased	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations International normalised ratio increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Lipase increased	6.0% 6/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.9% 3/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.0% 9/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Liver function test increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Monocyte count decreased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Monocyte count increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Pancreatic enzymes increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Platelet count increased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Prothrombin time prolonged	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations Serum ferritin decreased	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Investigations White blood cell count increased	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Dehydration	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.67% 2/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.1% 3/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Arthritis	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Nervous system disorders Dizziness	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Nervous system disorders Headache	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	3.9% 4/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.7% 8/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Nervous system disorders Neuropathy peripheral	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Psychiatric disorders Anxiety	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 3/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Psychiatric disorders Depression	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Psychiatric disorders Insomnia	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Renal and urinary disorders Dysuria	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Renal and urinary disorders Hydronephrosis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Renal and urinary disorders Renal pain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Renal and urinary disorders Ureterolithiasis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Vascular disorders Phlebitis superficial	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Cough	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Rash	3.0% 3/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.3% 4/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.98% 1/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.33% 1/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Vascular disorders Hypertension	1.0% 1/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/98 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	2.0% 2/102 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	1.7% 5/300 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.	0.00% 0/100 • Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER