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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-JE-LYED | Other Identifier | Eli Lilly and Company |
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The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Leading to Discontinuation | over 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 466-8560 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21265936 | Result | Takahashi M, Takita Y, Goto T, Ichikawa H, Saito K, Matsumoto H, Tanaka Y. An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder. Psychiatry Clin Neurosci. 2011 Feb;65(1):55-63. doi: 10.1111/j.1440-1819.2010.02159.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | 40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| baseline and 8 weeks |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. | baseline and 8 weeks |
| Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | baseline and 8 weeks |
| Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | baseline and 8 weeks |
| Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe). | baseline and 8 weeks |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score*10+50 in each subscale. | baseline and 8 weeks |
| Change From Endpoint to Baseline in Stroop Color Word Test | An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list. | baseline and 8 weeks |
| Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). | over 8 weeks |
| Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%. | over 8 weeks |
| Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | The Fridericia correction of the QT interval(QTcF) was used. | over 8 weeks |
| Cytochrome P450 2D6 (CYP2D6) Phenotype Status | CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. | 8 weeks |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 272-8516 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukushima | 960-1295 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | 060-8648 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 661-0002 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ishikawa | 920-8641 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 259-1193 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kumamoto | 862-0920 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | 606-8507 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nara | 634-8522 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | 350-0495 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 160-0023 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | 40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||||
| Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale | Measures severity of the patient's overall severity of attention-deficit/hyperactivity disorder (ADHD) symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-Inv:SV-J ADHD Index Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. ADHD Index Subscale consisted of 12 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 36. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-Inv:SV-J Hyperactive/Impulsive Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. Hyperactive/Impulsive Subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-Inv:SV-J Inattentive Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator:Screening Version-Japanese. Inattention subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-Inv:SV-J Total Symptoms Score | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version-Japanese . Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-S:SV-J ADHD Index Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. ADHD Index Subscale consisted of 12 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 36. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-S:SV-J Hyperactive/Impulsive Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Hyperactive/Impulsive Subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-S:SV-J Inattentive Subscale | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Inattention subscale consisted of 9 items, using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Conners' Adult ADHD Rating Scale-S:SV-J Total Symptoms Score | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Subject:Screening Version-Japanese. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Hamilton Anxiety Rating Scale-14 Items Total Score | The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Hamilton Depression Rating Scale-17 Items Total Score | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day. | Posted | Number | participants | over 8 weeks |
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| Secondary | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
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| Secondary | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
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| Secondary | Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe). | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
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| Secondary | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score*10+50 in each subscale. | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
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| Secondary | Change From Endpoint to Baseline in Stroop Color Word Test | An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list. | All enrolled participants with Last Observation Carried Forward. | Posted | Mean | Standard Deviation | number of correct answers | baseline and 8 weeks |
|
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| Secondary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). | All enrolled participants. | Posted | Number | participants | over 8 weeks |
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| Secondary | Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%. | All enrolled participants. | Posted | Number | participants | over 8 weeks |
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| Secondary | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | The Fridericia correction of the QT interval(QTcF) was used. | All enrolled participants. | Posted | Number | participants | over 8 weeks |
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| Secondary | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. | Posted | Number | participants | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | 40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks | 0 | 45 | 45 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MEDDRA (11.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MEDDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA (11.0) | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MEDDRA (11.0) | Systematic Assessment |
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| Malaise | General disorders | MEDDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA (11.0) | Systematic Assessment |
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| Thirst | General disorders | MEDDRA (11.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA (11.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MEDDRA (11.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA (11.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MEDDRA (11.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MEDDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA (11.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MEDDRA (11.0) | Systematic Assessment |
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| Tremor | Nervous system disorders | MEDDRA (11.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MEDDRA (11.0) | Systematic Assessment |
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| Middle insomnia | Psychiatric disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MEDDRA (11.0) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MEDDRA (11.0) | Systematic Assessment |
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| Hot flush | Vascular disorders | MEDDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| QTcF Interval of >450 milliseconds (ms) |
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| QTcF Interval of >480 milliseconds |
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| QTcF Interval of >500 milliseconds |
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| QTcF Interval increase from baseline of ≥30 msec |
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| QTcF Interval increase from baseline of ≥60 msec |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Extensive Metabolizer |
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| Poor Metabolizer |
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