Trial Outcomes & Findings for Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients (NCT NCT04667949)

NCT ID: NCT04667949

Last Updated: 2026-01-13

Results Overview

A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 98 participants
• Primary outcome timeframe: Baseline to Month 24
• Results posted on: 2026-01-13

Participant Flow

Participants were enrolled at 13 sites in China

There were up to 30 days of screening period (day -30 to -1) before first treatment (day 1).

Participant milestones

Measure	Fingolimod (< 18 Years) Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Overall Study STARTED	11	87
Overall Study COMPLETED	10	75
Overall Study NOT COMPLETED	1	12

Reasons for withdrawal

Measure	Fingolimod (< 18 Years) Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	0	2
Overall Study Subject decision	1	7

Baseline Characteristics

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Baseline characteristics by cohort

Measure	Fingolimod (< 18 Years) n=11 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=87 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over	Total n=98 Participants Total of all reporting groups
Age, Continuous	12.8 years STANDARD_DEVIATION 1.60 • n=210 Participants	32.3 years STANDARD_DEVIATION 9.11 • n=19 Participants	30.1 years STANDARD_DEVIATION 10.58 • n=123 Participants
Sex: Female, Male Female	3 Participants n=210 Participants	51 Participants n=19 Participants	54 Participants n=123 Participants
Sex: Female, Male Male	8 Participants n=210 Participants	36 Participants n=19 Participants	44 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	11 Participants n=210 Participants	87 Participants n=19 Participants	98 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) White	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Age categorical Children 2-11 years	2 Participants n=210 Participants	0 Participants n=19 Participants	2 Participants n=123 Participants
Age categorical Adolescents 12-17 years	9 Participants n=210 Participants	0 Participants n=19 Participants	9 Participants n=123 Participants
Age categorical Adults 18-64 years	0 Participants n=210 Participants	87 Participants n=19 Participants	87 Participants n=123 Participants
Number of relapses in the last 12 months prior to screening	1.7 relapses/year STANDARD_DEVIATION 1.27 • n=210 Participants	1.2 relapses/year STANDARD_DEVIATION 0.47 • n=19 Participants	1.3 relapses/year STANDARD_DEVIATION 0.62 • n=123 Participants
Number of relapses in 12 to 24 months prior to screening	0.8 relapses/year STANDARD_DEVIATION 1.25 • n=210 Participants	0.7 relapses/year STANDARD_DEVIATION 0.84 • n=19 Participants	0.7 relapses/year STANDARD_DEVIATION 0.89 • n=123 Participants

PRIMARY outcome

Timeframe: Baseline to Month 24

Population: Adult participants in the Full Analysis Set (FAS). FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician.

The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained.

As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs.

Outcome measures

Measure	Fingolimod (< 18 Years) n=87 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Adjusted Annualized Relapse Rate (ARR) in Adult Group	0.018 relapses per participant-year Interval 0.006 to 0.061	—

SECONDARY outcome

Timeframe: From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months

An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study.

For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity.

Outcome measures

Measure	Fingolimod (< 18 Years) n=11 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=87 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) Serious adverse events (SAEs)	3 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) Adverse events (AEs)	11 Participants	86 Participants
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) Study treatment related AEs	10 Participants	81 Participants
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) AEs leading to interruption of study treatment	3 Participants	11 Participants
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) AEs leading to study discontinuation	1 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) AEs leading to death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to end of treatment (up to Month 24)

Population: Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure.. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable.

The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset.

Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group.

Outcome measures

Measure	Fingolimod (< 18 Years) n=81 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Annualized Rate of the Number of New or Newly Enlarged T2 Lesions	1.316 Lesions per participant-year Interval 0.762 to 2.272	—

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Number of new/newly enlarged T2 lesions since baseline as measured by MRI

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=81 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Change From Baseline in Number of New or Newly Enlarged T2 Lesions 12 months	1.8 new / newly enlarged T2 lesions Standard Deviation 1.93	1.8 new / newly enlarged T2 lesions Standard Deviation 4.18
Change From Baseline in Number of New or Newly Enlarged T2 Lesions 24 months	2.1 new / newly enlarged T2 lesions Standard Deviation 2.18	2.4 new / newly enlarged T2 lesions Standard Deviation 4.84

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=79 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Change From Baseline in T2 Lesion Volume 24 months	-1.6736 milliliters Interval -17.1 to 36.719	0.4065 milliliters Interval -5.741 to 26.322
Change From Baseline in T2 Lesion Volume 12 months	0.6140 milliliters Interval -17.607 to 34.748	0.3930 milliliters Interval -6.343 to 25.158

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable.

The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset.

MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group.

Outcome measures

Measure	Fingolimod (< 18 Years) n=80 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Number of Gd-enhancing T1 Lesions Per Scan in Adult Group	0.376 Lesions per participant per scan Interval 0.216 to 0.655	—

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Number of Gd-enhancing T1 lesions as measured by MRI

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=79 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Number of Gd-enhancing T1 Lesions 12 months	0.4 T1 lesions Standard Deviation 0.70	0.4 T1 lesions Standard Deviation 0.84
Number of Gd-enhancing T1 Lesions 24 months	0 T1 lesions Standard Deviation 0.00	0.4 T1 lesions Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=79 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Change From Baseline in Gd-enhancing T1 Lesion Volume 12 months	-56.0 microliters Interval -1392.5 to 418.0	0.00 microliters Interval -1869.0 to 546.0
Change From Baseline in Gd-enhancing T1 Lesion Volume 24 months	-56.0 microliters Interval -632.7 to 0.0	0.00 microliters Interval -1869.0 to 1082.0

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

Number of T1 hypo-intense lesions as measured by MRI

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=79 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Number of T1 Hypo-intense Lesions 12 months	14.6 T1 hypo-intense lesions Standard Deviation 12.97	17.0 T1 hypo-intense lesions Standard Deviation 13.62
Number of T1 Hypo-intense Lesions 24 months	13.4 T1 hypo-intense lesions Standard Deviation 10.86	16.7 T1 hypo-intense lesions Standard Deviation 13.27

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value

Outcome measures

Measure	Fingolimod (< 18 Years) n=10 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=79 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Change From Baseline in T1 Hypo-intense Lesion Volume 12 months	-77.500 microliters Interval -6849.3 to 20341.8	44.000 microliters Interval -4921.3 to 19035.0
Change From Baseline in T1 Hypo-intense Lesion Volume 24 months	-641.415 microliters Interval -7444.5 to 1161.5	187.100 microliters Interval -5772.2 to 19264.0

POST_HOC outcome

Timeframe: Baseline to Month 24

Population: Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection.

A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).

Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25.

Outcome measures

Measure	Fingolimod (< 18 Years) n=11 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=87 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Participant Based Annualized Relapse Rate (ARR) All relapses - Participant based	0.1952 relapses per participant-year Standard Deviation 0.50314	0.0969 relapses per participant-year Standard Deviation 0.50002
Participant Based Annualized Relapse Rate (ARR) Confirmed relapses - Participant based	0.0460 relapses per participant-year Standard Deviation 0.15253	0.0372 relapses per participant-year Standard Deviation 0.24424

POST_HOC outcome

Timeframe: Baseline to Month 24

Population: Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment.

A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).

Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days.

Outcome measures

Measure	Fingolimod (< 18 Years) n=11 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old	Fingolimod > 18 Years n=87 Participants Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
Time Based Annualized Relapse Rate (ARR) All relapses - Time based	0.161 relapses per participant-year	0.065 relapses per participant-year
Time Based Annualized Relapse Rate (ARR) Confirmed relapses - Time based	0.054 relapses per participant-year	0.019 relapses per participant-year

Adverse Events

Less Than 18 Years

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Greater Than or Equal to 18 Years

Serious events: 12 serious events

Other events: 85 other events

Deaths: 0 deaths

Overall

Serious events: 15 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Measure	Less Than 18 Years n=11 participants at risk Less than 18 years	Greater Than or Equal to 18 Years n=87 participants at risk Greater than or equal to 18 years	Overall n=98 participants at risk Overall
Infections and infestations COVID-19	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Eye disorders Iridocyclitis	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Hepatobiliary disorders Liver injury	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.4% 3/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Febrile infection	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Infection	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Pneumonia	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Tonsillitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Injury, poisoning and procedural complications Limb injury	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Musculoskeletal and connective tissue disorders Muscle twitching	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Acute disseminated encephalomyelitis	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Epilepsy	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Seizure	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Syncope	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Pregnancy, puerperium and perinatal conditions Abortion complete	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months

Other adverse events

Measure	Less Than 18 Years n=11 participants at risk Less than 18 years	Greater Than or Equal to 18 Years n=87 participants at risk Greater than or equal to 18 years	Overall n=98 participants at risk Overall
Infections and infestations Gingivitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	11.5% 10/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	10.2% 10/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Nasopharyngitis	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	10.3% 9/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	13.3% 13/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Bronchitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Blood and lymphatic system disorders Lymphopenia	63.6% 7/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	27.6% 24/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	31.6% 31/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Blood and lymphatic system disorders Neutropenia	27.3% 3/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	5.1% 5/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Cardiac disorders Sinus bradycardia	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	14.9% 13/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	13.3% 13/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Cardiac disorders Ventricular extrasystoles	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Ear and labyrinth disorders Cerumen impaction	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Eye disorders Conjunctivitis allergic	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Eye disorders Ocular hypertension	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Eye disorders Refraction disorder	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Eye disorders Strabismus	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Gastrointestinal disorders Diarrhoea	27.3% 3/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	5.7% 5/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	8.2% 8/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Gastrointestinal disorders Haematemesis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Gastrointestinal disorders Nausea	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Gastrointestinal disorders Vomiting	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
General disorders and administration site conditions Chest discomfort	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
General disorders and administration site conditions Chest pain	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
General disorders and administration site conditions Influenza like illness	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.4% 3/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	4.1% 4/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations COVID-19	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	40.2% 35/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	37.8% 37/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
General disorders and administration site conditions Pyrexia	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	13.8% 12/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	16.3% 16/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Blood and lymphatic system disorders Hypoglobulinaemia	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Blood and lymphatic system disorders Leukopenia	45.5% 5/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	25.3% 22/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	27.6% 27/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Pharyngitis	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	4.1% 4/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Tonsillitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Upper respiratory tract infection	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	24.1% 21/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	25.5% 25/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Infections and infestations Urinary tract infection	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	18.4% 16/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	16.3% 16/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Alanine aminotransferase increased	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	37.9% 33/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	35.7% 35/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	21.8% 19/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	20.4% 20/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Blood cholesterol increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Electrocardiogram PR shortened	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.4% 3/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	4.1% 4/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Electrocardiogram ST segment abnormal	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Electrocardiogram high voltage	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Gamma-glutamyltransferase increased	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	11.5% 10/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	10.2% 10/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Liver function test abnormal	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Lymphocyte count decreased	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	60.9% 53/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	56.1% 55/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Lymphocyte percentage decreased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	8.0% 7/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	8.2% 8/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Monocyte count increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Neutrophil count decreased	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	4.6% 4/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	6.1% 6/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Neutrophil percentage increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Platelet count increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.3% 2/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Protein urine present	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	3.1% 3/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations SARS-CoV-2 test positive	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Urinary sediment present	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Weight decreased	45.5% 5/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	9.2% 8/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	13.3% 13/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations Weight increased	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	9.2% 8/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	12.2% 12/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations White blood cell count decreased	36.4% 4/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	25.3% 22/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	26.5% 26/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations White blood cell count increased	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Investigations White blood cells urine positive	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	9.2% 8/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	10.2% 10/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	10.3% 9/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	9.2% 9/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Musculoskeletal and connective tissue disorders Muscle twitching	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Dizziness	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	4.6% 4/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	5.1% 5/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Headache	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	11.5% 10/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	12.2% 12/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Seizure	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Nervous system disorders Syncope	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.1% 1/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	2.0% 2/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Psychiatric disorders Initial insomnia	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Renal and urinary disorders Leukocyturia	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Renal and urinary disorders Urine abnormality	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Reproductive system and breast disorders Balanoposthitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	11.5% 10/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	12.2% 12/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	6.9% 6/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	6.1% 6/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Skin and subcutaneous tissue disorders Hair colour changes	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Skin and subcutaneous tissue disorders Nail bed inflammation	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Skin and subcutaneous tissue disorders Neurodermatitis	9.1% 1/11 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	0.00% 0/87 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months	1.0% 1/98 • Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months

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