Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00388505
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2006-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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 the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.', 'otherNumAtRisk': 308, 'otherNumAffected': 241, 'seriousNumAtRisk': 308, 'seriousNumAffected': 85}, {'id': 'EG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.', 'otherNumAtRisk': 209, 'otherNumAffected': 148, 'seriousNumAtRisk': 209, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Cystic fibrosis lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Distal ileal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Distal intestinal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatic insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatosplenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopulmonary aspergillosis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pseudomonas bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oxygen saturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Benign lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Increased bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to AE(s)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to SAE(s)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '25 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Safety population.'}, {'type': 'SECONDARY', 'title': 'Serum Tobramycin Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Week 1: Predose [N=28, 14]', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: 0 to 2 hours [N=28, 14]', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: 2 to 5 hours (1st sample) [N=26, 14]', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: 2 to 5 hours (2nd sample) [N=25, 12]', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 5: Predose [N=23, 13]', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 5: 0 to 2 hours [N=23, 12]', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 5: 2 to 5 hours (1st sample) [N=23, 11]', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 5: 2 to 5 hours (2nd sample) [N=23, 8]', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 17: Predose [N=24, 13]', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 17: 0 to 2 hours [N=24, 13]', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 17: 2 to 5 hours (1st sample) [N=24, 12]', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 17: 2 to 5 hours (2nd sample) [N=23, 12]', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 21: Predose [N=24, 13]', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 21: 0 to 2 hours [N=24, 12]', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 21: 2 to 5 hours (1st sample) [N=22, 12]', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 21: 2 to 5 hours (2nd sample) [N=24, 11]', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 5, 17 and 21', 'description': 'Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic subpopulation'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease From Baseline in Auditory Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Cycle 1, Day 28 [N=60, 39]', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 28 [N=55, 34]', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3, Day 28 [N=54, 34]', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)', 'description': 'Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Audiology subpopulation'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Baseline [N=308, 209]', 'categories': [{'measurements': [{'value': '52.9', 'spread': '14.20', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '15.95', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 5 [N=268, 194]', 'categories': [{'measurements': [{'value': '2.8', 'spread': '19.64', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '14.33', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 13 [N=252, 178]', 'categories': [{'measurements': [{'value': '2.3', 'spread': '18.76', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '16.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 21 [N=227, 171]', 'categories': [{'measurements': [{'value': '3.1', 'spread': '19.92', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '17.57', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Final Visit [N=307, 209]', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '17.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)', 'description': 'Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.\n\nRelative change = 100 \\* ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value).', 'unitOfMeasure': 'percent of predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Cycle 1: Effectiveness [N=264, 189]', 'categories': [{'measurements': [{'value': '74.1', 'spread': '17.29', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '18.63', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1: Side Effects [N=263, 190]', 'categories': [{'measurements': [{'value': '92.1', 'spread': '15.58', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '15.99', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1: Convenience [N=264, 190]', 'categories': [{'measurements': [{'value': '82.3', 'spread': '14.95', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '20.64', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1: Global Satisfaction [N=264, 190]', 'categories': [{'measurements': [{'value': '75.4', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '20.19', 'spread': '18.67', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2: Effectiveness [N=241, 170]', 'categories': [{'measurements': [{'value': '74.5', 'spread': '17.62', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '17.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2: Side Effects [N=239, 170]', 'categories': [{'measurements': [{'value': '93.6', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '93.8', 'spread': '13.41', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2:Convenience [N=241, 170]', 'categories': [{'measurements': [{'value': '81.1', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '20.40', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2: Global Satisfaction [N=241, 170]', 'categories': [{'measurements': [{'value': '76.6', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '19.40', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3: Effectiveness [N=221, 162]', 'categories': [{'measurements': [{'value': '74.9', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '65.5', 'spread': '17.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3: Side Effects [N=215, 158]', 'categories': [{'measurements': [{'value': '91.5', 'spread': '17.78', 'groupId': 'OG000'}, {'value': '94.1', 'spread': '14.48', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3: Convenience [N=221, 162]', 'categories': [{'measurements': [{'value': '81.6', 'spread': '16.89', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '20.90', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3: Global Satisfaction [N=221, 162]', 'categories': [{'measurements': [{'value': '75.2', 'spread': '24.00', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '17.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).', 'description': "Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Baseline [N=279, 192]', 'categories': [{'measurements': [{'value': '7.23', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 5 [N=202, 145]', 'categories': [{'measurements': [{'value': '-1.76', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 13 [N=170, 125]', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 21 [N= 157, 126]', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Final Visit [N=263, 179]', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).', 'description': "Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.", 'unitOfMeasure': 'log10 Colony forming units/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tobramycin Minimum Inhibitory Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'title': 'Baseline [N=308, 208]', 'categories': [{'measurements': [{'value': '35.39', 'spread': '107.58', 'groupId': 'OG000'}, {'value': '42.45', 'spread': '116.40', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 5 [N=239, 173]', 'categories': [{'measurements': [{'value': '38.47', 'spread': '148.34', 'groupId': 'OG000'}, {'value': '5.80', 'spread': '112.96', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8 [N=215, 157]', 'categories': [{'measurements': [{'value': '35.59', 'spread': '148.03', 'groupId': 'OG000'}, {'value': '20.68', 'spread': '130.57', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 21 [N=199, 154]', 'categories': [{'measurements': [{'value': '29.83', 'spread': '139.85', 'groupId': 'OG000'}, {'value': '14.13', 'spread': '117.54', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Final Visit [N=298, 202]', 'categories': [{'measurements': [{'value': '30.89', 'spread': '139.63', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '107.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)', 'description': 'The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.'}, {'type': 'SECONDARY', 'title': 'Antipseudomonal Antibiotic Usage During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '31.24', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '37.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 Weeks', 'description': 'The average number of days patients required antipseudomonal antibiotics during the course of the study.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the intent-to-treat population who required antipseudomonal antibiotics.'}, {'type': 'SECONDARY', 'title': 'Hospitalization Due to Respiratory Events During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'OG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '13.31', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '10.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 Weeks', 'description': 'The average number of days patients were hospitalized due to respiratory events during the course of the study.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the intent-to-treat population who were hospitalized due to respiratory events.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'FG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized patients who received any amount of study medication', 'groupId': 'FG000', 'numSubjects': '308'}, {'comment': 'Randomized patients who received any amount of study medication', 'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event or Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Inappropriate Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tobramycin Inhalation Powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'BG001', 'title': 'Tobramycin Solution for Inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '11.36', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '10.20', 'groupId': 'BG001'}, {'value': '25.6', 'spread': '10.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥6 to <13 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '≥13 to <20 years', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': '≥20 years', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 517}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2006-10-16', 'resultsFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2006-10-16', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-19', 'studyFirstPostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events', 'timeFrame': '25 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.'}], 'secondaryOutcomes': [{'measure': 'Serum Tobramycin Concentrations', 'timeFrame': 'Weeks 1, 5, 17 and 21', 'description': 'Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).'}, {'measure': 'Percentage of Participants With a Decrease From Baseline in Auditory Acuity', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)', 'description': 'Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.'}, {'measure': 'Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)', 'description': 'Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.\n\nRelative change = 100 \\* ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value).'}, {'measure': 'Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication', 'timeFrame': 'Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).', 'description': "Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain."}, {'measure': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).', 'description': "Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density."}, {'measure': 'Change From Baseline in Tobramycin Minimum Inhibitory Concentration', 'timeFrame': 'Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)', 'description': 'The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.'}, {'measure': 'Antipseudomonal Antibiotic Usage During the Study', 'timeFrame': '25 Weeks', 'description': 'The average number of days patients required antipseudomonal antibiotics during the course of the study.'}, {'measure': 'Hospitalization Due to Respiratory Events During the Study', 'timeFrame': '25 Weeks', 'description': 'The average number of days patients were hospitalized due to respiratory events during the course of the study.'}]}, 'conditionsModule': {'keywords': ['tobramycin'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/webapp/etrials/home.do', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of cystic fibrosis\n* Male and female patients at least 6 years of age at the time of screening.\n* Forced expiratory volume in one second (FEV1) at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.\n* Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage \\[BAL\\]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.\n* Able to comply with all protocol requirements.\n* Clinically stable in the opinion of the investigator.\n* Use of an effective means of contraception in females of childbearing potential.\n* Provide written informed consent, Health Authority Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.\n\nExclusion Criteria:\n\n* History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.\n* Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study drug administration.\n* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.\n* Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.\n* History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator.\n* Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.\n* Use of loop diuretics within 7 days prior to study drug administration.\n* Use of any investigational treatment within 28 days prior to study drug administration.\n* Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled corticosteroids within 28 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration).\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00388505', 'acronym': 'EAGER', 'briefTitle': 'Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects', 'orgStudyIdInfo': {'id': 'CTBM100C2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobramycin inhalation powder (TIP)', 'description': 'Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.', 'interventionNames': ['Drug: Tobramycin Inhalation Powder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobramycin solution for inhalation (TOBI)', 'description': 'Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.', 'interventionNames': ['Drug: Tobramycin Solution for Inhalation']}], 'interventions': [{'name': 'Tobramycin Inhalation Powder', 'type': 'DRUG', 'description': 'Tobramycin Inhalation Powder (TIP) capsules for inhalation.', 'armGroupLabels': ['Tobramycin 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