Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD) (NCT NCT04988087)

NCT ID: NCT04988087

Last Updated: 2024-10-09

Results Overview

The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2024-10-09

Participant Flow

Participants took part in 10 investigative sites in 6 countries/regions.

There was a screening period of up to 6 weeks to assess participants eligibility.

Participant milestones

Measure	MHV370 200mg - SjS MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
Overall Study STARTED	12	14	2	2
Overall Study COMPLETED	0	4	1	0
Overall Study NOT COMPLETED	12	10	1	2

Reasons for withdrawal

Measure	MHV370 200mg - SjS MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
Overall Study Adverse Event	4	0	0	0
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study Technical problems	7	9	1	2

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)

Baseline characteristics by cohort

Measure	MHV370 200mg - SjS n=12 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=14 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD n=2 Participants MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD n=2 Participants Placebo oral dose, twice daily. MCTD participants.	Total n=30 Participants Total of all reporting groups
Age, Continuous	49.3 years STANDARD_DEVIATION 12.20 • n=5 Participants	54.7 years STANDARD_DEVIATION 9.67 • n=7 Participants	35.0 years STANDARD_DEVIATION 12.73 • n=5 Participants	44.0 years STANDARD_DEVIATION 0.00 • n=4 Participants	50.5 years STANDARD_DEVIATION 11.52 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	11 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. The data includes only participants who completed Week 24. Only participants with evaluable records are included.

The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=4 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment	—	-4.39 Score on scale Standard Error 2.41	—	—

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. The data includes only participants who completed Week 24. Only participants with evaluable records are included.

The physician's global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). A negative change score from baseline indicates improvement. Only participants with evaluable records are included.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment	-62.00 Score on scale Interval -62.0 to -62.0	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4

Population: The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included.

Cmax is the maximum (peak) observed plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Cmax was determined using non-compartmental methods.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=1 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State	278 ng/mL Standard Deviation 85.7	194 ng/mL	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4

Population: The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included.

The AUC from time zero to the 6-hours post-dose sampling time. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. AUClast was determined using non-compartmental methods.

Outcome measures

Measure	MHV370 200mg - SjS n=5 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=1 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370	1060 ng*h/mL Standard Deviation 462	742 ng*h/mL	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4

Population: The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included.

Tmax is the time to reach maximum (peak) plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Tmax was determined using non-compartmental methods.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=1 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State	1.50 hours Interval 1.0 to 4.0	2.00 hours	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 20 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F v4) is a short, 13-item patient-reported measure, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where a higher FACIT-F score indicates more severe symptoms. A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=12 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD n=2 Participants MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD n=1 Participants Placebo oral dose, twice daily. MCTD participants.
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Week 8	3.14 Score on scale Standard Deviation 5.928	-2.80 Score on scale Standard Deviation 4.185	20.00 Score on scale Standard Deviation 7.071	-2.00 Score on scale
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Week 12	-1.25 Score on scale Standard Deviation 6.702	2.71 Score on scale Standard Deviation 8.826	20.00 Score on scale	—
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Week 20	-9.42 Score on scale	4.80 Score on scale Standard Deviation 8.758	23.00 Score on scale	—
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Week 24	—	5.75 Score on scale Standard Deviation 10.782	30.00 Score on scale	—
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Week 4	0.13 Score on scale Standard Deviation 3.271	-1.58 Score on scale Standard Deviation 6.052	15.50 Score on scale Standard Deviation 9.192	-3.00 Score on scale

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 20 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

The physician's global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=12 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD n=2 Participants MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD n=1 Participants Placebo oral dose, twice daily. MCTD participants.
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) Week 4	-1.75 Score on scale Standard Deviation 12.658	-5.25 Score on scale Standard Deviation 11.185	-20.50 Score on scale Standard Deviation 12.021	-15.00 Score on scale
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) Week 12	-4.00 Score on scale Standard Deviation 20.559	-19.43 Score on scale Standard Deviation 14.328	-66.00 Score on scale	—
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) Week 24	—	-30.75 Score on scale Standard Deviation 19.534	-62.00 Score on scale	—
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) Week 8	2.57 Score on scale Standard Deviation 12.608	-8.90 Score on scale Standard Deviation 11.474	-39.00 Score on scale Standard Deviation 18.385	-12.50 Score on scale
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) Week 20	3.00 Score on scale	-14.60 Score on scale Standard Deviation 22.423	-64.00 Score on scale	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 20 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Only participants with evaluable records are included.

The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=12 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 4	-0.25 Score on scale Standard Deviation 1.753	-3.67 Score on scale Standard Deviation 9.355	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 8	0.57 Score on scale Standard Deviation 6.528	-4.80 Score on scale Standard Deviation 11.487	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 24	—	-0.25 Score on scale Standard Deviation 11.117	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 12	-3.00 Score on scale Standard Deviation 4.583	-3.43 Score on scale Standard Deviation 7.656	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 20	-2.00 Score on scale	0.00 Score on scale Standard Deviation 14.629	—	—

SECONDARY outcome

Timeframe: baseline, weeks 4, 8, 12, 20 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Only participants with evaluable records are included.

The ESSPRI is an established disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index which consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). The participant can assess severity of symptoms they experience on a single numerical scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable) for each of the three domains. The overall ESSPRI score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where a higher ESSPRI score indicates more severe symptoms. A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS n=8 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=12 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) Week 8	-0.67 Score on scale Standard Deviation 0.793	-0.37 Score on scale Standard Deviation 1.511	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) Week 4	-0.12 Score on scale Standard Deviation 0.354	-0.53 Score on scale Standard Deviation 1.105	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) Week 12	-0.42 Score on scale Standard Deviation 0.500	-1.38 Score on scale Standard Deviation 1.976	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) Week 20	-0.17 Score on scale	-2.20 Score on scale Standard Deviation 1.865	—	—
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) Week 24	—	-2.00 Score on scale Standard Deviation 2.000	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data.

Unstimulated whole salivary fluid secretions were collected over 5 minutes from participants. All assessments were performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition. Participants were instructed not to eat, drink or smoke for 90 minutes before the assessment. The start time and end time of saliva collection were recorded to calculate the salivary flow rate per minute. Only participants with evaluable records are included.

Outcome measures

Measure	MHV370 200mg - SjS n=12 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=14 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Change From Baseline to the Salivary Flow Rate Week 24	—	0.564 mL/min Standard Deviation 0.9193	—	—
SjS Participants: Change From Baseline to the Salivary Flow Rate Week 4	0.162 mL/min Standard Deviation 0.2735	-0.127 mL/min Standard Deviation 0.7914	—	—
SjS Participants: Change From Baseline to the Salivary Flow Rate Week 12	0.144 mL/min Standard Deviation 0.2109	0.183 mL/min Standard Deviation 0.3944	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Only participants with evaluable records are included.

Schirmer's test is used to determine whether the eye produces enough tears to keep it moist especially for those who suffer from dry eye syndrome. A strip is placed in the lower eyelid for 5 minutes to assess tear production. After 5 minutes, the filter paper is removed and the distance between the leading edge of wetness and the initial fold is measured, using a millimeter ruler. Tear deficiency is defined as <5 mm wetting of the paper after 5 minutes.

Outcome measures

Measure	MHV370 200mg - SjS n=12 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=14 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Change From Baseline to the Schirmer's Test Week 4, right eye	-1.5 milimeter Standard Deviation 4.87	0.0 milimeter Standard Deviation 3.59	—	—
SjS Participants: Change From Baseline to the Schirmer's Test Week 24, right eye	—	-3.0 milimeter Standard Deviation 6.32	—	—
SjS Participants: Change From Baseline to the Schirmer's Test Week 4, left eye	1.1 milimeter Standard Deviation 1.96	1.6 milimeter Standard Deviation 6.01	—	—
SjS Participants: Change From Baseline to the Schirmer's Test Week 24, left eye	—	-1.0 milimeter Standard Deviation 2.94	—	—
SjS Participants: Change From Baseline to the Schirmer's Test Week 12, right eye	-1.0 milimeter Standard Deviation 2.16	5.3 milimeter Standard Deviation 8.81	—	—
SjS Participants: Change From Baseline to the Schirmer's Test Week 12, left eye	2.0 milimeter Standard Deviation 1.83	4.9 milimeter Standard Deviation 12.50	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Missing responses will be treated as non-responders. Only participants with evaluable records are included.

STAR is a composite responder index, including in a single tool all main disease features, and designed for use as a key efficacy endpoint in SjS Domain Point Definition of response.

Points are assigned in the following 5 domains, if the corresponding criteria are met:

• Systemic activity, if decrease in clin ESSDAI ≥ 3 points: 3 points
• Patient reported outcome, if decrease in ESSPRI ≥ 1 point or 15%: 3 points
• Lacrimal gland function (assessed by Schirmer's test), if abnormal score at baseline: increase ≥ 5 mm from baseline OR if normal score at baseline: no change to abnormal: 1 point
• Salivary gland function (assessed by unstimulated salivary flow), if increase ≥ 25% from baseline: 1 point
• Biological (assessed by serum IgG levels), if decrease ≥ 10%: 1 point The Total Score is the sum of all 5 domain scores, ranging from 0 to 9 points. A STAR responder is defined as ≥ 5 points in the Total Score.

Outcome measures

Measure	MHV370 200mg - SjS n=12 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=14 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
SjS Participants: Sjögren's Tool for Assessing Response (STAR) Response Over Time up to Week 24 Week 4	0 Participants	3 Participants	—	—
SjS Participants: Sjögren's Tool for Assessing Response (STAR) Response Over Time up to Week 24 Week 12	1 Participants	4 Participants	—	—
SjS Participants: Sjögren's Tool for Assessing Response (STAR) Response Over Time up to Week 24 Week 24	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. Participants with Mixed Connective Tissue Disease (MCTD) completed the articular (from 0 "no activity" to 3 "high activity") and pulmonary (from 0 "no activity to 3 "high activity") domains of the ESSDAI only. For MCTD participants, the score range is 0-21, where a higher score indicates more severe symptoms. A negative change score from baseline indicates improvement.

Outcome measures

Measure	MHV370 200mg - SjS n=2 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=1 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 4 - articular	0.00 Score on scale Standard Deviation 0.000	0.00 Score on scale	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 8 - articular	-1.00 Score on scale Standard Deviation 0.000	0.00 Score on scale	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 12 - articular	-1.00 Score on scale	—	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 24 - articular	-2.00 Score on scale	—	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 4 - pulmonary	0.00 Score on scale Standard Deviation 0.000	0.00 Score on scale	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 8 - pulmonary	-0.50 Score on scale Standard Deviation 0.707	0.00 Score on scale	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 12 - pulmonary	-1.00 Score on scale	—	—	—
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) Week 24 - pulmonary	-1.00 Score on scale	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Forced Vital Capacity (FVC)	0.530 liters (L)	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 is considered a favourable outcome.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Second (FEV1) of a Forced Breath	0.250 liters (L)	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

FEV2 (forced expiratory volume in two seconds) is the amount of air which can be forcibly exhaled from the lungs in the first two seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV2 is considered a favourable outcome.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Two Seconds (FEV2) of a Forced Breath	0.410 liters (L)	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

FEV3 (forced expiratory volume in three seconds) is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV3 is considered a favourable outcome.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Three Seconds (FEV3) of a Forced Breath	0.460 liters (L)	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. The outcome is presented as percentage of predicted DLCO value.

Outcome measures

Measure	MHV370 200mg - SjS n=1 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=2 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Baseline	84.0 percentage of predicted DLCO	95.5 percentage of predicted DLCO Standard Deviation 2.12	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

The K-BILD questionnaire is a self-administered health-status questionnaire that has been developed in patients with interstitial lung diseases. It consists of 15 items in three domains: breathlessness and activities, psychological factors, and chest symptoms. Total scores range from 0 to 100, with higher scores representing better health status.

Outcome measures

Measure	MHV370 200mg - SjS n=2 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=1 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Week 4	3.00 Score on scale Standard Deviation 4.243	-2.00 Score on scale	—	—
MCTD Participants: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Week 8	13.00 Score on scale Standard Deviation 9.899	0.00 Score on scale	—	—
MCTD Participants: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Week 12	21.00 Score on scale	—	—	—
MCTD Participants: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Week 24	58.00 Score on scale	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

Population: The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included.

The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon and impact of Raynaud's alone on use of hands every day. An 11-point Likert scale is used to rate the difficulty caused by the condition with 0 = no difficulty and 10 = extreme difficulty. Participants are asked to select the number that best describes their difficulty, with higher score indicating worse condition.

Outcome measures

Measure	MHV370 200mg - SjS n=2 Participants MHV370 200mg oral dose, twice daily. SjS participants.	Placebo - SjS n=2 Participants Placebo oral dose, twice daily. SjS participants.	MHV370 200mg - MCTD MHV370 200mg oral dose, twice daily. MCTD participants.	Placebo - MCTD Placebo oral dose, twice daily. MCTD participants.
MCTD Participants: Change From Baseline in Raynaud's Condition Score (RCS) Week 4	-2.50 Score on scale Standard Deviation 3.536	1.00 Score on scale	—	—
MCTD Participants: Change From Baseline in Raynaud's Condition Score (RCS) Week 12	-1.00 Score on scale	—	—	—
MCTD Participants: Change From Baseline in Raynaud's Condition Score (RCS) Week 24	-2.00 Score on scale	—	—	—

Adverse Events

sjs_MHV

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

sjs_Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

MCTD_MHV

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MCTD_Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Total

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	sjs_MHV n=12 participants at risk sjs\_MHV	sjs_Placebo n=14 participants at risk sjs\_Placebo	MCTD_MHV n=2 participants at risk MCTD\_MHV	MCTD_Placebo n=2 participants at risk MCTD\_Placebo	Total n=30 participants at risk Total
Reproductive system and breast disorders Ovarian cyst	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.

Other adverse events

Measure	sjs_MHV n=12 participants at risk sjs\_MHV	sjs_Placebo n=14 participants at risk sjs\_Placebo	MCTD_MHV n=2 participants at risk MCTD\_MHV	MCTD_Placebo n=2 participants at risk MCTD\_Placebo	Total n=30 participants at risk Total
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Blood and lymphatic system disorders Leukopenia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	21.4% 3/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	10.0% 3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Blood and lymphatic system disorders Lymphopenia	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	21.4% 3/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	10.0% 3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Cardiac disorders Extrasystoles	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Cardiac disorders Palpitations	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Cardiac disorders Sinus bradycardia	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Endocrine disorders Thyroid mass	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Eye disorders Cataract	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Eye disorders Conjunctival suffusion	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	14.3% 2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Constipation	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Dental caries	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	10.0% 3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Duodenitis	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Gastritis	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Hiatus hernia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Mouth swelling	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Nausea	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Gastrointestinal disorders Parotid gland enlargement	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
General disorders Asthenia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
General disorders Feeling hot	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
General disorders Malaise	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
General disorders Pyrexia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
General disorders Swelling	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Immune system disorders Allergy to arthropod bite	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations COVID-19	33.3% 4/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	14.3% 2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	20.0% 6/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Cystitis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Dacryocanaliculitis	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Helicobacter infection	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Herpes zoster	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Otitis media	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Pharyngitis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Rash pustular	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Rhinitis	16.7% 2/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	10.0% 3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Urinary tract infection	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Infections and infestations Viral infection	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Activated partial thromboplastin time prolonged	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Alanine aminotransferase increased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Amylase increased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Antinuclear antibody increased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Blood creatinine increased	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Complement factor C3 decreased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	14.3% 2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Complement factor C4 decreased	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Glomerular filtration rate decreased	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Neutrophil count decreased	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Investigations Weight increased	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	14.3% 2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Metabolism and nutrition disorders Hyperuricaemia	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 2/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	10.0% 3/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Dizziness	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	6.7% 2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Facial paralysis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Headache	16.7% 2/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	28.6% 4/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	26.7% 8/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Hypergeusia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Neuralgia	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Nervous system disorders Sciatica	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Psychiatric disorders Insomnia	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 3/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	14.3% 2/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	16.7% 5/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	7.1% 1/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Skin and subcutaneous tissue disorders Acne	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Vascular disorders Hypertension	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
Vascular disorders Vasculitis	8.3% 1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/14 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.	3.3% 1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: novartis.email@novartis.com

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