Trial Outcomes & Findings for An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT01060150)

NCT ID: NCT01060150

Last Updated: 2013-08-23

Results Overview

The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 115 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2013-08-23

Participant Flow

Participant milestones

Measure	OROS Methylphenidate HCl Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Study STARTED	115
Overall Study Treated	113
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	OROS Methylphenidate HCl Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	6
Overall Study Withdrawal by Subject	8
Overall Study Enrolled, but not treated	2

Baseline Characteristics

An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	OROS Methylphenidate HCl n=113 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Age Continuous	15.24 Years STANDARD_DEVIATION 1.43 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Korean Version of Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score	27.58 Units on a scale STANDARD_DEVIATION 8.92 • n=5 Participants
Clinical Global Impression - Severity (CGI-S) Score	4.88 Units on a scale STANDARD_DEVIATION 0.79 • n=5 Participants
Learning Skill Test (LST) Total Score	40.97 T-score STANDARD_DEVIATION 11.07 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).

The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.

Outcome measures

Measure

OROS Methylphenidate HCl n=113 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12

Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score

11.78 Units on a scale Standard Deviation 7.64

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.

The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

Outcome measures

Measure

OROS Methylphenidate HCl n=113 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12

Clinical Global Impression - Severity (CGI-S) Score

2.81 Units on a scale Standard Deviation 1.12

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Outcome measures

Measure

OROS Methylphenidate HCl n=103 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12

Clinical Global Impression - Improvement (CGI-I) Score

2.14 Units on a scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.

Outcome measures

Measure

OROS Methylphenidate HCl n=98 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12

Learning Skill Test (LST) Total Score

49.61 T-score Standard Deviation 11.57

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.

Outcome measures

Measure	OROS Methylphenidate HCl n=101 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors Omission errors: Baseline	58.88 Errors Standard Deviation 27.35
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors Omission errors: Week 12	57.40 Errors Standard Deviation 48.79
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors Commission errors: Baseline	62.98 Errors Standard Deviation 32.32
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors Commission errors: Week 12	51.70 Errors Standard Deviation 21.19

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit.

Outcome measures

Measure	OROS Methylphenidate HCl n=101 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability Reaction time average: Baseline	54.32 Units on scale Standard Deviation 15.45
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability Reaction time average: Week 12	49.73 Units on scale Standard Deviation 26.33
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability Response variability: Baseline	85.77 Units on scale Standard Deviation 60.21
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability Response variability: Week 12	59.42 Units on scale Standard Deviation 64.77

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Digit Span Test Score Forward: Baseline	11.19 Units on a scale Standard Deviation 2.92
Digit Span Test Score Forward: Week 12	11.56 Units on a scale Standard Deviation 2.90
Digit Span Test Score Backward: Baseline	7.09 Units on a scale Standard Deviation 2.39
Digit Span Test Score Backward: Week 12	7.32 Units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Finger Window (FW) Test Score Forward FW: Baseline	18.42 Units on a scale Standard Deviation 4.60
Finger Window (FW) Test Score Forward FW: Week 12	19.09 Units on a scale Standard Deviation 4.49
Finger Window (FW) Test Score Backward FW: Baseline	15.59 Units on a scale Standard Deviation 4.97
Finger Window (FW) Test Score Backward FW: Week 12	17.36 Units on a scale Standard Deviation 3.84

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Controlled Oral Words Association Test (COWAT) Score Category/semantic: Baseline	29.71 Words Standard Deviation 5.86
Controlled Oral Words Association Test (COWAT) Score Category/semantic: Week 12	30.62 Words Standard Deviation 6.16
Controlled Oral Words Association Test (COWAT) Score Letter/phenomic: Baseline	28.71 Words Standard Deviation 10.82
Controlled Oral Words Association Test (COWAT) Score Letter/phenomic: Week 12	33.78 Words Standard Deviation 11.18

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Stroop Test Result for Reaction Time Simple execution time: Baseline	14.78 Seconds Standard Deviation 3.8
Stroop Test Result for Reaction Time Simple execution time: Week 12	13.64 Seconds Standard Deviation 3.27
Stroop Test Result for Reaction Time Middle execution time: Baseline	15.88 Seconds Standard Deviation 3.56
Stroop Test Result for Reaction Time Middle execution time: Week 12	15.04 Seconds Standard Deviation 4.57
Stroop Test Result for Reaction Time Interfering execution time: Baseline	22.12 Seconds Standard Deviation 6.18
Stroop Test Result for Reaction Time Interfering execution time: Week 12	19.72 Seconds Standard Deviation 5.63

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Stroop Test Result for False Reaction Simple execution false reaction: Baseline	0.4 Errors Standard Deviation 0.77
Stroop Test Result for False Reaction Simple execution false reaction: Week 12	0.16 Errors Standard Deviation 0.39
Stroop Test Result for False Reaction Middle execution false reaction: Baseline	0.3 Errors Standard Deviation 0.67
Stroop Test Result for False Reaction Middle execution false reaction: Week 12	0.2 Errors Standard Deviation 0.47
Stroop Test Result for False Reaction Interfering execution false reaction: Baseline	1.04 Errors Standard Deviation 1.29
Stroop Test Result for False Reaction Interfering execution false reaction: Week 12	0.84 Errors Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.

Outcome measures

Measure	OROS Methylphenidate HCl n=100 Participants Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Stroop Test Score for Ratio Interference Baseline	0.70 Units on a scale Standard Deviation 0.19
Stroop Test Score for Ratio Interference Week 12	0.72 Units on a scale Standard Deviation 0.19

Adverse Events

OROS Methylphenidate HCl

Serious events: 2 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	OROS Methylphenidate HCl n=113 participants at risk Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Blood and lymphatic system disorders Lymphadenitis	0.88% 1/113 • After signing of informed consent up to Week 12
Infections and infestations Appendicitis	0.88% 1/113 • After signing of informed consent up to Week 12

Other adverse events

Measure	OROS Methylphenidate HCl n=113 participants at risk Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
Metabolism and nutrition disorders Decreased appetite	58.4% 66/113 • After signing of informed consent up to Week 12
Gastrointestinal disorders Nausea	28.3% 32/113 • After signing of informed consent up to Week 12
Gastrointestinal disorders Abdominal pain upper	16.8% 19/113 • After signing of informed consent up to Week 12
Gastrointestinal disorders Stomach discomfort	13.3% 15/113 • After signing of informed consent up to Week 12
Gastrointestinal disorders Vomiting	6.2% 7/113 • After signing of informed consent up to Week 12
Gastrointestinal disorders Diarrhoea	5.3% 6/113 • After signing of informed consent up to Week 12
Psychiatric disorders Insomnia	32.7% 37/113 • After signing of informed consent up to Week 12
Psychiatric disorders Anxiety	8.0% 9/113 • After signing of informed consent up to Week 12
Psychiatric disorders Depression	8.0% 9/113 • After signing of informed consent up to Week 12
Psychiatric disorders Nervousness	6.2% 7/113 • After signing of informed consent up to Week 12
Psychiatric disorders Anger	5.3% 6/113 • After signing of informed consent up to Week 12
Nervous system disorders Headache	27.4% 31/113 • After signing of informed consent up to Week 12
Nervous system disorders Dizziness	9.7% 11/113 • After signing of informed consent up to Week 12
Nervous system disorders Somnolence	7.1% 8/113 • After signing of informed consent up to Week 12
General disorders Irritability	14.2% 16/113 • After signing of informed consent up to Week 12
General disorders Fatigue	11.5% 13/113 • After signing of informed consent up to Week 12
Infections and infestations Nasopharyngitis	16.8% 19/113 • After signing of informed consent up to Week 12
Cardiac disorders Palpitations	7.1% 8/113 • After signing of informed consent up to Week 12
Musculoskeletal and connective tissue disorders Myalgia	5.3% 6/113 • After signing of informed consent up to Week 12

Additional Information

Clinical Research Director

Medical Affairs / Janssen-Cil Korea

Phone: 82-2-2094-4518

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60