Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 7:59 PM
Study NCT ID:
NCT01259492
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2010-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '8627788300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'N of safety analysis set for Period 1=722. Data in the entire three periods were included. A patient may be counted under both treatment arms. Which means, if a patient received placebo in Period 1 and Ritalin in Period 3, he/she was counted under both 695 and 275. That is why 695+275 \\> 722.', 'eventGroups': [{'id': 'EG000', 'title': 'All Ritalin LA', 'description': "All Ritalin LA:\n\nIn period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose.", 'otherNumAtRisk': 695, 'otherNumAffected': 517, 'seriousNumAtRisk': 695, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.", 'otherNumAtRisk': 275, 'otherNumAffected': 104, 'seriousNumAtRisk': 275, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adjustment disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '10.12', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '11.36', 'groupId': 'OG002'}, {'value': '9.7', 'spread': '11.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': 'Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("Never") to 4 ("Very often"). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 - DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \\<= - 30%.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '7.31', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '7.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': "SDS, a 5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores \\>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Failures During Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'title': 'Without Imputation - Treatment failure', 'categories': [{'measurements': [{'value': '11.8', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '17.5', 'spread': '7.31', 'groupId': 'OG002'}, {'value': '43.5', 'spread': '7.47', 'groupId': 'OG003'}]}]}, {'title': 'Without Imputation - Not treatment failure', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '56.1', 'groupId': 'OG002'}, {'value': '31.3', 'groupId': 'OG003'}]}]}, {'title': 'Without Imputation missing failure status', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '29.7', 'groupId': 'OG001'}, {'value': '25.4', 'groupId': 'OG002'}, {'value': '25.2', 'groupId': 'OG003'}]}]}, {'title': 'With Imputation - Treatment failure', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}, {'value': '20.2', 'groupId': 'OG002'}, {'value': '49.6', 'groupId': 'OG003'}]}]}, {'title': 'With Imputation - Not treatment failure', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}, {'value': '79.8', 'groupId': 'OG002'}, {'value': '50.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40', 'description': 'Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) \\>= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \\> - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54', 'unitOfMeasure': 'Percentage of participants', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}, {'value': '31.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': 'On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N \\* 100.', 'unitOfMeasure': 'Percentage of Patients', 'populationDescription': 'Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included.'}, {'type': 'SECONDARY', 'title': "Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALL Ritalin LA Group', 'description': 'This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492'}], 'classes': [{'title': 'DSM-IV ADHD RS total score n=494', 'categories': [{'measurements': [{'value': '24.8', 'spread': '8.97', 'groupId': 'OG000'}]}]}, {'title': 'SDS total score n=480', 'categories': [{'measurements': [{'value': '10.1', 'spread': '7.25', 'groupId': 'OG000'}]}]}, {'title': 'CAARS-O:S total score n=411', 'categories': [{'measurements': [{'value': '15.5', 'spread': '15.25', 'groupId': 'OG000'}]}]}, {'title': 'ASRS total score n=490', 'categories': [{'measurements': [{'value': '23.2', 'spread': '14.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 ("Never") to 4 ("Very often").', 'unitOfMeasure': 'Score on Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALL Ritalin LA Group', 'description': 'This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492'}], 'classes': [{'title': 'very much improved', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}]}]}, {'title': 'much improved', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}]}]}, {'title': 'minimally improved', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'no change', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'minimally worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change from baseline", 5 = "minimally worse", 6 = "much worse" 7 = "very much worse"', 'unitOfMeasure': 'number of participants', 'populationDescription': 'Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALL Ritalin LA Group', 'description': 'This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492'}], 'classes': [{'title': 'Normal, not ill at all', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'borderline mentally ill', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}]}]}, {'title': 'mildly ill', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'moderately ill', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'markedly ill', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'severely ill', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'among the most extremely ill patients', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'CGI-S assesses the patient\'s current illness state. CGI-S consists of 7 ratings that range from 1 = "normal, not at all ill" , 2 = "borderline mentally ill", 3 =" mildly ill", 4 = "moderately ill", 5 = "markedly ill", 6 = "severely ill", 7 = "among the most extremely ill patients"', 'unitOfMeasure': 'number of participants', 'populationDescription': 'Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '10.85', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '8.67', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '11.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.19', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '6.81', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '8.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient\'s work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more "impaired" a patient\'s work, social life, family life is.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale.', 'unitOfMeasure': 'participants', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'CGI-S assesses the patient\'s current illness state. CGI-S consists of 7 ratings that range from 1 = "normal, not at all ill" , 2 = "borderline mentally ill", 3 =" mildly ill", 4 = "moderately ill", 5 = "markedly ill", 6 = "severely ill", 7 = "among the most extremely ill patients"', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '12.00', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '14.23', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '15.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is "not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3". The total score combined from all the 26 items ranges from 0 to 88.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'OG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '12.64', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '11.54', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '16.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 ("Never") to 4 ("Very often"). The total score ranges from 0 to 72.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'FG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'FG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'FG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}], 'periods': [{'title': 'Period 1 (9 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '181'}, {'groupId': 'FG003', 'numSubjects': '181'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '179'}, {'groupId': 'FG003', 'numSubjects': '172'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '"Completed" indicates patients entered Period 2.', 'groupId': 'FG000', 'numSubjects': '152'}, {'comment': 'Completed = entered Period 2', 'groupId': 'FG001', 'numSubjects': '141'}, {'comment': 'Completed = entered Period 2', 'groupId': 'FG002', 'numSubjects': '138'}, {'comment': 'Completed = entered Period 2', 'groupId': 'FG003', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 2 (Week 10 to Week 14)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treatment arms including Placebo indicate patients belong to respective treatment arms in Period 1', 'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '138'}, {'groupId': 'FG003', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed = entered Period 3', 'groupId': 'FG000', 'numSubjects': '127'}, {'comment': 'Completed = entered Period 3', 'groupId': 'FG001', 'numSubjects': '123'}, {'comment': 'Completed = entered Period 3', 'groupId': 'FG002', 'numSubjects': '114'}, {'comment': 'Completed = entered Period 3', 'groupId': 'FG003', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3 (Week 15 to End of Week 40)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'In period 3, all 489 patients who completed period 2 were re-randomized to 4 arms.', 'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '123'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '114'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed study', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'completed study', 'groupId': 'FG001', 'numSubjects': '63'}, {'comment': 'completed study', 'groupId': 'FG002', 'numSubjects': '70'}, {'comment': 'completed study', 'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Abnormal Lab value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Abnormal Test Procedure Result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '62'}]}, {'type': 'Patient no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}, {'value': '725', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'BG001', 'title': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'BG002', 'title': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'BG003', 'title': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-30', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '287', 'groupId': 'BG004'}]}]}, {'title': '31-40', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}]}, {'title': '41-50', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}]}, {'title': '51-60', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Period 1', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '18-30', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '185', 'groupId': 'BG004'}]}]}, {'title': '31-40', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}]}, {'title': '41-50', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}]}, {'title': '51-60', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Period 3', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '330', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '395', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Period 1', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '216', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '273', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Period 3', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 725}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2010-12-11', 'resultsFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2010-12-11', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-27', 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': 'Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("Never") to 4 ("Very often"). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 - DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \\<= - 30%.'}, {'measure': 'Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': "SDS, a 5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores \\>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording."}, {'measure': 'Percentage of Participants With Treatment Failures During Period 3', 'timeFrame': 'Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40', 'description': 'Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) \\>= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \\> - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1', 'timeFrame': 'Baseline 1 to End of Period 1 (Week 9)', 'description': 'On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N \\* 100.'}, {'measure': "Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)", 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 ("Never") to 4 ("Very often").'}, {'measure': 'Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)', 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change from baseline", 5 = "minimally worse", 6 = "much worse" 7 = "very much worse"'}, {'measure': 'Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)', 'timeFrame': 'Baseline 1 to End of Period 2 (Week 14)', 'description': 'CGI-S assesses the patient\'s current illness state. CGI-S consists of 7 ratings that range from 1 = "normal, not at all ill" , 2 = "borderline mentally ill", 3 =" mildly ill", 4 = "moderately ill", 5 = "markedly ill", 6 = "severely ill", 7 = "among the most extremely ill patients"'}, {'measure': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.'}, {'measure': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient\'s work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more "impaired" a patient\'s work, social life, family life is.'}, {'measure': 'Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale.'}, {'measure': 'Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'CGI-S assesses the patient\'s current illness state. CGI-S consists of 7 ratings that range from 1 = "normal, not at all ill" , 2 = "borderline mentally ill", 3 =" mildly ill", 4 = "moderately ill", 5 = "markedly ill", 6 = "severely ill", 7 = "among the most extremely ill patients"'}, {'measure': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is "not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3". The total score combined from all the 26 items ranges from 0 to 88.'}, {'measure': 'Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment', 'timeFrame': 'Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)', 'description': 'The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 ("Never") to 4 ("Very often"). The total score ranges from 0 to 72.'}]}, 'conditionsModule': {'keywords': ['Attention Deficit /Hyperactivity Disorder, hyperactivity'], 'conditions': ['Attention Deficit/Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '24371021', 'type': 'DERIVED', 'citation': 'Huss M, Ginsberg Y, Tvedten T, Arngrim T, Philipsen A, Carter K, Chen CW, Kumar V. Methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial. Adv Ther. 2014 Jan;31(1):44-65. doi: 10.1007/s12325-013-0085-5. Epub 2013 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood\n2. Female patients of childbearing potential must be practicing an acceptable method of contraception.\n\nExclusion criteria:\n\n1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2\n2. History of alcohol or substance abuse within the last six months.\n3. History of seizures or use of anticonvulsant medication.\n4. Any psychiatric condition that requires medication or may interfere with study participation.\n5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.\n6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder\n7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma\n8. Diagnosis or family history of Tourette's syndrome\n9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT01259492', 'briefTitle': 'Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD', 'orgStudyIdInfo': {'id': 'CRIT124D2302'}, 'secondaryIdInfos': [{'id': '2010-021533-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ritalin LA 40 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.", 'interventionNames': ['Drug: Ritalin LA 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ritalin LA 60 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.", 'interventionNames': ['Drug: Ritalin LA 20 mg', 'Drug: Ritalin LA 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ritalin LA 80 mg', 'description': "In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.", 'interventionNames': ['Drug: Ritalin LA 20 mg', 'Drug: Ritalin LA 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator: Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Ritalin LA 20 mg', 'type': 'DRUG', 'description': 'Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg.', 'armGroupLabels': ['Ritalin LA 40 mg', 'Ritalin LA 60 mg', 'Ritalin LA 80 mg']}, {'name': 'Ritalin LA 30 mg', 'type': 'DRUG', 'description': 'Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 60, or 80 mg.', 'armGroupLabels': ['Ritalin LA 60 mg', 'Ritalin LA 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 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