Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:32 AM
Study NCT ID:
NCT00191906
Status:
COMPLETED
Last Update Posted:
2010-05-25
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
Sponsor:
Organization:
Raw JSON
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[{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'As Randomized Placebo (Crossover)', 'description': 'Patients in either Crossover Period receiving Placebo', 'otherNumAtRisk': 76, 'otherNumAffected': 28, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'As Randomized Atomoxetine (Crossover)', 'description': 'Patients in either Crossover Period receiving Atomoxetine', 'otherNumAtRisk': 74, 'otherNumAffected': 35, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Open Label Atomoxetine', 'description': 'Patients in the Open Label extension receiving Atomoxetine', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mydriasis', 'stats': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Negativism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Job dissatisfaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '299.90', 'spread': '13.29', 'groupId': 'OG000'}, {'value': '308.82', 'spread': '14.53', 'groupId': 'OG001'}]}]}, {'title': 'Reading Disorder', 'categories': [{'measurements': [{'value': '265.61', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '260.51', 'spread': '16.02', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-C + Reading Disorder', 'categories': [{'measurements': [{'value': '277.38', 'spread': '13.80', 'groupId': 'OG000'}, {'value': '292.53', 'spread': '15.46', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '280.97', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '287.29', 'spread': '8.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.504', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.', 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C', 'description': 'atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type'}, {'id': 'OG001', 'title': 'Normal Control', 'description': 'Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.95', 'spread': '48.21', 'groupId': 'OG000'}, {'value': '11.22', 'spread': '62.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.970', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C+RD', 'description': 'atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder'}, {'id': 'OG001', 'title': 'Reading Disorder', 'description': 'atomoxetine-treated Reading Disorder'}, {'id': 'OG002', 'title': 'Reading Disordered Control', 'description': 'Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '53.41', 'groupId': 'OG000'}, {'value': '-34.0', 'spread': '33.91', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '24.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.144', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Lexical Decision Task Mean Reaction Time: Correct Words', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '1182.9', 'spread': '50.23', 'groupId': 'OG000'}, {'value': '1291.9', 'spread': '38.13', 'groupId': 'OG001'}]}]}, {'title': 'Reading Disorder', 'categories': [{'measurements': [{'value': '1172.4', 'spread': '51.75', 'groupId': 'OG000'}, {'value': '1198.6', 'spread': '40.24', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-C + Reading Disorder', 'categories': [{'measurements': [{'value': '1201.9', 'spread': '51.22', 'groupId': 'OG000'}, {'value': '1305.9', 'spread': '39.43', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '1185.7', 'spread': '29.49', 'groupId': 'OG000'}, {'value': '1265.5', 'spread': '22.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Lexical Decision Task Mean Reaction Time: Pseudo Words', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '1403.0', 'spread': '63.72', 'groupId': 'OG000'}, {'value': '1475.4', 'spread': '50.08', 'groupId': 'OG001'}]}]}, {'title': 'Reading Disorder', 'categories': [{'measurements': [{'value': '1365.0', 'spread': '65.62', 'groupId': 'OG000'}, {'value': '1412.2', 'spread': '52.90', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-C + Reading Disorder', 'categories': [{'measurements': [{'value': '1426.1', 'spread': '64.83', 'groupId': 'OG000'}, {'value': '1487.0', 'spread': '51.73', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '1398.0', 'spread': '37.33', 'groupId': 'OG000'}, {'value': '1458.2', 'spread': '29.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Working Memory by Corsi Block Tapping Test (CBTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '5.29', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Reading Disorder', 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-C + Reading Disorder', 'categories': [{'measurements': [{'value': '5.92', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '5.57', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.', 'unitOfMeasure': 'blocks correctly sequenced', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '30.86', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '35.20', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '22.44', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '35.17', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '26.65', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '35.18', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '15.27', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '17.82', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '12.25', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '18.28', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '13.76', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '18.05', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '15.51', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '17.24', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '10.32', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '17.03', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '12.91', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '17.13', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '-2.76', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).', 'unitOfMeasure': 'T-Score of units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '3.69', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '2.98', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.76', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '3.34', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 week therapy endpoint', 'description': "Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, daily, by mouth for 4 weeks.'}], 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '3.65', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '3.85', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 week therapy endpoint', 'description': "Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C', 'description': 'atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type'}, {'id': 'OG001', 'title': 'Normal Control', 'description': 'Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}], 'classes': [{'categories': [{'measurements': [{'value': '-230.40', 'spread': '239.43', 'groupId': 'OG000'}, {'value': '-339.17', 'spread': '176.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.508', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C', 'description': 'atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type'}, {'id': 'OG001', 'title': 'Normal Control', 'description': 'Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}], 'classes': [{'categories': [{'measurements': [{'value': '-523.20', 'spread': '524.36', 'groupId': 'OG000'}, {'value': '-536.00', 'spread': '303.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C+ RD', 'description': 'atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder'}, {'id': 'OG001', 'title': 'Reading Disorder', 'description': 'atomoxetine-treated Reading Disorder'}, {'id': 'OG002', 'title': 'Reading Disordered Control', 'description': 'Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-170.81', 'spread': '243.33', 'groupId': 'OG000'}, {'value': '-241.00', 'spread': '317.47', 'groupId': 'OG001'}, {'value': '-254.86', 'spread': '266.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.663', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD-C+RD', 'description': 'atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder'}, {'id': 'OG001', 'title': 'Reading Disorder', 'description': 'atomoxetine-treated Reading Disorder'}, {'id': 'OG002', 'title': 'Reading Disordered Control', 'description': 'Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-113.06', 'spread': '432.68', 'groupId': 'OG000'}, {'value': '-213.00', 'spread': '512.33', 'groupId': 'OG001'}, {'value': '-368.14', 'spread': '422.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.', 'groupDescription': 'ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine First, Then Placebo', 'description': 'Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.'}, {'id': 'FG001', 'title': 'Placebo First, Then Atomoxetine', 'description': 'Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.'}, {'id': 'FG002', 'title': 'Normal Control', 'description': 'Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}, {'id': 'FG003', 'title': 'Reading Disordered Control', 'description': 'Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.'}], 'periods': [{'title': 'Study Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Parent/Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Study Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'These are patients who continued in optional open-label period (1 country). All received atomoxetine', 'groupId': 'FG000', 'numSubjects': '14'}, {'comment': 'These are patients who continued in optional open-label period (1 country). All received atomoxetine', 'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Parent/Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Period I: screening/washout (89 patients screened, 13 screen-failures;45 controls screened). Period II (Visits 2-5): patients received treatment for 4 weeks and then underwent 2-week washout period after which they crossed over to receive the alternate treatment for 4 additional weeks. Period III (Visits 6-12): optional open-label (1 country only).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine First, Then Placebo', 'description': 'Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks'}, {'id': 'BG001', 'title': 'Placebo First, Then Atomoxetine', 'description': 'Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.'}, {'id': 'BG002', 'title': 'Normal Control', 'description': 'Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}, {'id': 'BG003', 'title': 'Reading Disordered Control', 'description': 'Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '1.34', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '1.25', 'groupId': 'BG001'}, {'value': '9.9', 'spread': '1.01', 'groupId': 'BG002'}, {'value': '10.6', 'spread': '0.99', 'groupId': 'BG003'}, {'value': '10.0', 'spread': '1.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Study Arm - Diagnosis', 'classes': [{'title': 'ADHD-Combined Type', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Reading Disorder', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': 'ADHD-Combined Type + Reading Disorder', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'No Disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2008-12-11', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-19', 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.'}, {'measure': 'Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': 'SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.'}, {'measure': 'Lexical Decision Task Mean Reaction Time: Correct Words', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.'}, {'measure': 'Lexical Decision Task Mean Reaction Time: Pseudo Words', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.'}, {'measure': 'Working Memory by Corsi Block Tapping Test (CBTT)', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.'}, {'measure': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.'}, {'measure': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.'}, {'measure': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.'}, {'measure': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score', 'timeFrame': 'Baseline and Week 4 of initial therapy and Week 4 of crossover therapy', 'description': 'Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).'}, {'measure': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale', 'timeFrame': '4 week therapy endpoint', 'description': "Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened)."}, {'measure': 'Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale', 'timeFrame': '4 week therapy endpoint', 'description': "Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients)."}, {'measure': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly."}, {'measure': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly."}, {'measure': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly."}, {'measure': 'Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words', 'timeFrame': 'Baseline and 4 weeks of therapy', 'description': "Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder', 'Reading Disorder']}, 'referencesModule': {'references': [{'pmid': '25019647', 'type': 'DERIVED', 'citation': 'Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.'}, {'pmid': '20035588', 'type': 'DERIVED', 'citation': 'de Jong CG, Van De Voorde S, Roeyers H, Raymaekers R, Allen AJ, Knijff S, Verhelst H, Temmink AH, Smit LM, Rodriques-Pereira R, Vandenberghe D, van Welsen I, ter Schuren L, Al-Hakim M, Amin A, Vlasveld L, Oosterlaan J, Sergeant JA. Differential effects of atomoxetine on executive functioning and lexical decision in attention-deficit/hyperactivity disorder and reading disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):699-707. doi: 10.1089/cap.2009.0029.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder\n\nExclusion Criteria:\n\n* Patients with Conduct Disorder\n* Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.\n* Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.'}, 'identificationModule': {'nctId': 'NCT00191906', 'briefTitle': 'Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder.', 'orgStudyIdInfo': {'id': '7955'}, 'secondaryIdInfos': [{'id': 'B4Z-MC-LYCK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine first, then Placebo', 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks', 'interventionNames': ['Drug: Atomoxetine Hydrochloride', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo first, then Atomoxetine', 'description': 'Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks', 'interventionNames': ['Drug: Atomoxetine Hydrochloride', 'Drug: placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Control', 'description': 'Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.'}, {'type': 'NO_INTERVENTION', 'label': 'Reading Disordered Control', 'description': 'The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.'}], 'interventions': [{'name': 'Atomoxetine Hydrochloride', 'type': 'DRUG', 'otherNames': ['LY139603', 'Strattera'], 'description': 'Atomoxetine, 1.2 mg/kg/day, by mouth (PO)', 'armGroupLabels': ['Atomoxetine first, then Placebo', 'Placebo first, then Atomoxetine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo, every day (QD), by mouth (PO)', 'armGroupLabels': ['Atomoxetine first, then Placebo', 'Placebo first, then Atomoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': '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.', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '1311 RL', 'city': 'Almere Stad', 'country': 'Netherlands', 'facility': '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.', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '1081 BT', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': '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.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': '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.', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '5260 GB', 'city': 'Vught', 'country': 'Netherlands', 'facility': '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.', 'geoPoint': {'lat': 51.65333, 'lon': 5.2875}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 . Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}