| Primary | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline. | Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
| | | Title | Denominators | Categories |
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| Baseline: Inattention (n = 293) | | | | Baseline: Hyperactivity (n = 293) | | | | Baseline: Oppositional (n = 296) | |
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| Primary | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline. | ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Primary | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline. | ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Primary | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline. | ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Primary | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 | The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline. | ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support. | ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 2, 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Social Adjustment Scale Score for Children and Adolescents (SAICA) | SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem. | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4 and Week 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Clinical Global Impression-Severity (CGI-S) Score | CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill. | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 2, 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Number | | Participants | | Baseline, Week 2, 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Secondary | Global Assessment of Satisfaction by Parents/Caregivers | Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied. | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 2, 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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| Other Pre-specified | Global Assessment of Satisfaction by Participant | Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied. | ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 2, 4 and 8 | | | | ID | Title | Description |
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| OG000 | OROS MPH | Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. |
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