Trial Outcomes & Findings for This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year (NCT NCT03230097)

Last Updated: 2025-05-14

Results Overview

Incidence of remission from attenuated psychosis syndrome (APS) within a 52-week timeframe. The incidence rate per patient-years of remission from attenuated psychosis syndrome (APS) is reported. Remission from APS is defined as a score of \<3 on all of the five Positive Symptom items of the Scale of Prodromal Symptoms (SOPS) and maintained until the end of treatment. The SOPS provides a 6-point scale (minimum of 0 and maximum of 6, higher score indicating worse symptoms) to quantitatively rate the severity of five attenuated positive symptoms. incidence rate = number of events/total time at risk \[patient-years\].

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Up to 52 weeks.

Results posted on

2025-05-14

Participant Flow

This was a randomised, placebo-controlled, double-blind, parallel group trial over 52 weeks. The patients were randomised to 1 of the 2 treatment groups at a ratio of 1:1. After completion of the treatment period, or following early discontinuation, patients were to complete a 4-weeks follow-up period.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 409306 Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Overall Study STARTED	24	26
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	15	16

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 409306 Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Overall Study Adverse Event	2	1
Overall Study non-compliance	0	1
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	7	3
Overall Study Trial termination	4	5
Overall Study Covid-19 pandemic outbreak	0	1
Overall Study outcome event	0	1

Baseline Characteristics

This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 409306 n=24 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=26 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Total n=50 Participants Total of all reporting groups
Age, Continuous	23.4 years STANDARD_DEVIATION 4 • n=93 Participants	20.9 years STANDARD_DEVIATION 3.8 • n=4 Participants	22.1 years STANDARD_DEVIATION 4 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants	24 Participants n=4 Participants	43 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants	21 Participants n=4 Participants	37 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Schizophrenia Cognition Rating Scale (SCoRS) total score	36.333 Score on a scale STANDARD_DEVIATION 7.405 • n=93 Participants	36.462 Score on a scale STANDARD_DEVIATION 7.814 • n=4 Participants	36.400 Score on a scale STANDARD_DEVIATION 7.543 • n=27 Participants
Brief Assessment of Cognition (BAC App) composite T score	52.417 T-score STANDARD_DEVIATION 7.945 • n=93 Participants	49.308 T-score STANDARD_DEVIATION 13.451 • n=4 Participants	50.800 T-score STANDARD_DEVIATION 11.154 • n=27 Participants
Positive and Negative Syndrome Scale (PANSS) Positive scale subtotal	16.0 Score on a scale STANDARD_DEVIATION 3.9 • n=93 Participants	14.5 Score on a scale STANDARD_DEVIATION 3.4 • n=4 Participants	15.2 Score on a scale STANDARD_DEVIATION 3.7 • n=27 Participants
Positive and Negative Syndrome Scale (PANSS) Negative scale subtotal	14.4 Score on a scale STANDARD_DEVIATION 5.1 • n=93 Participants	13.4 Score on a scale STANDARD_DEVIATION 3.3 • n=4 Participants	13.9 Score on a scale STANDARD_DEVIATION 4.2 • n=27 Participants
Positive and Negative Syndrome Scale (PANSS) total	62.8 Score on a scale STANDARD_DEVIATION 12.5 • n=93 Participants	58.2 Score on a scale STANDARD_DEVIATION 11.0 • n=4 Participants	60.4 Score on a scale STANDARD_DEVIATION 11.8 • n=27 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks.

Population: Full Analysis Set (FAS): All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment and who have analysable data (observed or imputed) in at least one efficacy endpoint.

Outcome measures

Outcome measures
Measure	BI 409306 n=24 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=26 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe	0.433 remissions per patient-years	0.446 remissions per patient-years

SECONDARY outcome

Timeframe: Up to 52 weeks.

Incidence of first episode of psychosis. The incidence rate per patient-years of psychosis is reported, psychosis is defined as one or more positive Scale of Prodromal Symptoms (SOPS) symptoms rated a 6 AND either a symptom is seriously disorganizing or dangerous OR one of the symptoms above occurred at least one hour per day at an average frequency of four days/week over the past month. OR a new prescription or increase in dose of an ongoing antipsychotic medication. The SOPS provides a 6-point scale (minimum of 0 and maximum of 6, higher score indicating worse symptoms) to quantitatively rate the severity of five attenuated positive symptoms.

Outcome measures

Outcome measures
Measure	BI 409306 n=24 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=26 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Incidence of First Episode of Psychosis	0 first episodes per patient-years	0.125 first episodes per patient-years

SECONDARY outcome

Timeframe: Baseline, week 24 and week 52.

Population: All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment and who have analysable data (observed or imputed) for both timepoints in this endpoint.

Change from baseline (Day -28 to -7) in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 24 and 52 weeks of treatment. 20-item assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each of the 20 items of the SCoRS is rated on a 4-point scale (minimum of 1 and maximum of 4). Higher ratings reflect a greater degree of impairment. The composite score will be the sum of the 20 items (minimum of 20 and maximum of 80). Data analyzed using the restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.

Outcome measures

Outcome measures
Measure	BI 409306 n=10 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=15 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 24 and 52 Weeks of Treatment Adjusted mean change from baseline at week 24	-2.12 Score on a scale Interval -7.721 to 3.484	-3.89 Score on a scale Interval -8.925 to 1.148
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 24 and 52 Weeks of Treatment Adjusted mean change from baseline at week 52	-3.05 Score on a scale Interval -8.881 to 2.778	-6.23 Score on a scale Interval -11.53 to -0.927

SECONDARY outcome

Timeframe: Baseline and week 52.

Change from baseline (Day -28 to -7) in the tablet based Brief Assessment of Cognition (BAC App) composite T score after 52 weeks of treatment. The BAC consists of five tests assessing multiple domains of cognitive function: Verbal Memory, Digit Sequencing, Semantic and Letter Fluency, Symbol Coding, and Tower of London. A composite T score that is calculated using the five standardized scaled sub-test scores was generated (averages five of the standardized scaled sub-test scores, token motor test score not included), larger T-score indicates better cognition. Data analyzed using the REML MMRM including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction. T-scores in the general population have a mean of 50 and standard deviation of 10.

Outcome measures

Outcome measures
Measure	BI 409306 n=6 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=10 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Change From Baseline in the Tablet Based Brief Assessment of Cognition (BAC App) Composite T Score After 52 Weeks of Treatment	-1.51 T-score Interval -7.95 to 4.929	3.48 T-score Interval -1.641 to 8.597

SECONDARY outcome

Timeframe: Baseline and week 52.

Change from baseline (Day -28 to -7) in Positive and Negative Syndrome Scale (PANSS) positive items score, negative items score, and total score after 52 weeks of treatment. The PANSS positive and negative symptom scales each have 7 items, and the General Psychopathology Scale (not reported) has 16 items. The patient is rated from 1 to 7 on the 30 different items based on the interview, as well as reports from an informant when possible. Total score is the sum of the score of the 30 items (minimum 30, maximum 210), subtotal are the sum of either the positive or negative scales (minimum 7, maximum 49), lower scores represent an improvement in schizophrenia symptoms. Data analyzed using the REML MMRM including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline NAPLS risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.

Outcome measures

Outcome measures
Measure	BI 409306 n=9 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	Placebo n=10 Participants Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Items Score, Negative Items Score, and Total Score After 52 Weeks of Treatment Adjusted mean change from baseline at week 52, positive items score	-3.83 Score on a scale Interval -6.355 to -1.296	-3.03 Score on a scale Interval -5.312 to -0.743
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Items Score, Negative Items Score, and Total Score After 52 Weeks of Treatment Adjusted mean change from baseline at week 52, negative items score	-0.98 Score on a scale Interval -3.571 to 1.609	-2.41 Score on a scale Interval -4.788 to -0.032
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Items Score, Negative Items Score, and Total Score After 52 Weeks of Treatment Adjusted mean change from baseline at week 52, total score	-6.02 Score on a scale Interval -14.396 to 2.36	-7.73 Score on a scale Interval -15.216 to -0.245

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

BI 409306

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=26 participants at risk Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	BI 409306 n=24 participants at risk Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Nervous system disorders Seizure	3.8% 1/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Suicidal behaviour	3.8% 1/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Suicidal ideation	0.00% 0/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=26 participants at risk Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.	BI 409306 n=24 participants at risk Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
Blood and lymphatic system disorders Lymphadenopathy	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Chromatopsia	0.00% 0/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	12.5% 3/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Dyschromatopsia	0.00% 0/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	12.5% 3/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Photophobia	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	33.3% 8/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Visual impairment	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	20.8% 5/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Diarrhoea	11.5% 3/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8.3% 2/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Nausea	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8.3% 2/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Vomiting	19.2% 5/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Fatigue	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	12.5% 3/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Pyrexia	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Sinusitis	3.8% 1/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8.3% 2/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8.3% 2/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Contusion	11.5% 3/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Ligament sprain	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Blood creatine phosphokinase increased	15.4% 4/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Weight increased	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8.3% 2/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Dizziness	3.8% 1/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	33.3% 8/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Headache	30.8% 8/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	20.8% 5/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Anxiety	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	12.5% 3/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Insomnia	3.8% 1/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	20.8% 5/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Nightmare	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Sleep disorder	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	15.4% 4/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.5% 3/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Rash	7.7% 2/26 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.2% 1/24 • From treatment start date until the date of discontinuation of trial medication + 7 days, up to 381 days. The treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.