Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 6:02 PM
Study NCT ID:
NCT00128492
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}], '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'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mark.Bresnik@gilead.com', 'phone': '650-522-5934', 'title': 'Mark Bresnik, Director of Clinical Research', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'Institution and investigator may publish or present the results of the trial generated there with prior written consent of Gilead; or 2 years after the trial has ended at all institutions. Proposed publications/target venue must go to Gilead 30 days (manuscripts) or 15 days (abstracts/presentations) prior. Any Gilead confidential information in the document(s) must be deleted or, if requested publication, delayed for up to 45 days to permit Gilead to obtain intellectual property protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Descriptive statistics for all participants receiving 1 or more doses of AZLI were summarized for the safety, microbiology, and efficacy endpoints. No formal hypothesis tests were planned. Rates of AEs and SAEs are not adjusted for time on study.'}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals. Participants could receive up to 9 courses of AZLI, with total time on study of up to 18 months. Events occurring during the 18-month period are reported.', 'description': 'A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant at any time during the course of the study, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in death or hospitalization.', 'eventGroups': [{'id': 'EG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily', 'otherNumAtRisk': 85, 'otherNumAffected': 83, 'seriousNumAtRisk': 85, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily', 'otherNumAtRisk': 189, 'otherNumAffected': 185, 'seriousNumAtRisk': 189, 'seriousNumAffected': 100}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 24}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 15}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Breath sounds decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 45}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 19}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 166}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 83}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 15}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 104}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 80}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 11}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 59}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 70}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 17}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngeal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 83}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 155}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 37}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 83}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 90}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 62}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 24}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 50}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Antibacterial prophylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood chloride decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Breath sounds decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 58}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Distal intestinal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 19}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gastrostomy tube insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Infrequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Oxygen supplementation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 25}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sputum purulent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Number of Participants Reporting at Least One AE', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Participants Reporting at least One Related AE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants Reporting at Least One SAE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Study Drug Withdrawn due to AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants who Died on Study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.\n\nParticipants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Participants with <15% decline', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': 'Participants with >=15% decline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Change in Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'HR, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '1.08', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'HR, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'HR, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '3.87', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'HR was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Change in Systolic and Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Systolic BP, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '0.75', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '-1.06', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '0.49', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-1.64', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'BP was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'End of Treatment Course 1', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 9', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).\n\nDue to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.', 'unitOfMeasure': 'Log10 PA CFUs/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Other Pathogens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'S. aureus, Baseline', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'S. aureus, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'S. aureus, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'S. aureus, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'S. aureus, Follow-up', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'MSSA, Baseline', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'MSSA, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'MSSA, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'MSSA, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'MSSA, Follow-up', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'MRSA, Baseline', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'MRSA, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'MRSA, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'MRSA, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'MRSA, Follow-up', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'BCC, Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'BCC, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BCC, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'BCC, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BCC, Follow-up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia, Baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia, Follow-up', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans, Baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans, Follow-up', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Aspergillus Species, Baseline', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Aspergillus Species, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Aspergillus Species, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Aspergillus Species, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Aspergillus Species, Follow-up', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Candida Species, Baseline', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Candida Species, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Candida Species, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Candida Species, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Candida Species, Follow-up', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)', 'description': 'Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive \\[MSSA\\] and methicillin-resistant \\[MRSA\\] S.aureus), and fungal organisms.\n\nNumber of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Minimum Inhibitory Concentration (MIC) of Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'MIC50, Baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'MIC50, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'MIC50, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'MIC50, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'MIC50, Follow-up', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'MIC90, Baseline', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'MIC90, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}, {'title': 'MIC90, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}, {'title': 'MIC90, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}]}]}, {'title': 'MIC90, Follow-up', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)', 'description': 'The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.', 'unitOfMeasure': 'µg/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'FEV1 (L), End of Treatment Course 1', 'categories': [{'measurements': [{'value': '4.87', 'spread': '11.428', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '16.512', 'groupId': 'OG001'}]}]}, {'title': 'FEV1 (L), End of Treatment Course 3', 'categories': [{'measurements': [{'value': '3.55', 'spread': '12.491', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '16.489', 'groupId': 'OG001'}]}]}, {'title': 'FEV1 (L), End of Treatment Course 9', 'categories': [{'measurements': [{'value': '1.31', 'spread': '15.924', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '17.899', 'groupId': 'OG001'}]}]}, {'title': 'FEV1 Percent Predicted, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '4.91', 'spread': '11.599', 'groupId': 'OG000'}, {'value': '7.97', 'spread': '16.511', 'groupId': 'OG001'}]}]}, {'title': 'FEV1 Percent Predicted, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '3.46', 'spread': '12.504', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '16.592', 'groupId': 'OG001'}]}]}, {'title': 'FEV1 Percent Predicted, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '1.23', 'spread': '15.673', 'groupId': 'OG000'}, {'value': '4.24', 'spread': '17.992', 'groupId': 'OG001'}]}]}, {'title': 'FVC (L), End of Treatment Course 1', 'categories': [{'measurements': [{'value': '3.13', 'spread': '11.946', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '16.533', 'groupId': 'OG001'}]}]}, {'title': 'FVC (L), End of Treatment Course 3', 'categories': [{'measurements': [{'value': '1.77', 'spread': '10.948', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '13.178', 'groupId': 'OG001'}]}]}, {'title': 'FVC (L), End of Treatment Course 9', 'categories': [{'measurements': [{'value': '1.51', 'spread': '14.150', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '14.075', 'groupId': 'OG001'}]}]}, {'title': 'FEF25-75 (L/sec), End of Treatment Course 1', 'categories': [{'measurements': [{'value': '12.81', 'spread': '36.149', 'groupId': 'OG000'}, {'value': '14.14', 'spread': '36.089', 'groupId': 'OG001'}]}]}, {'title': 'FEF25-75 (L/sec), End of Treatment Course 3', 'categories': [{'measurements': [{'value': '16.05', 'spread': '55.447', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '32.579', 'groupId': 'OG001'}]}]}, {'title': 'FEF25-75 (L/sec), End of Treatment Course 9', 'categories': [{'measurements': [{'value': '3.24', 'spread': '28.506', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '36.329', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.\n\nFEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.\n\nThe percent change from baseline is presented for each endpoint.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'End of Treatment Course 1', 'categories': [{'measurements': [{'value': '3.53', 'spread': '12.243', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '17.379', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 3', 'categories': [{'measurements': [{'value': '0.37', 'spread': '19.296', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '18.518', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.30', 'spread': '15.217', 'groupId': 'OG000'}, {'value': '6.01', 'spread': '17.943', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Time to First Hospitalization Due to a Respiratory Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '359', 'spread': '27.60', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '431'}, {'value': '417', 'spread': '21.32', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '609'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).\n\nTime to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'End of Treatment Course 1', 'categories': [{'measurements': [{'value': '0.58', 'spread': '2.449', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '2.338', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 3', 'categories': [{'measurements': [{'value': '1.31', 'spread': '3.769', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '3.991', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Course 9', 'categories': [{'measurements': [{'value': '3.24', 'spread': '6.542', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '7.431', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Missed School/Work Days Due to CF Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.\n\nThe percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group.', 'unitOfMeasure': 'Percentage of days missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'SECONDARY', 'title': 'Time to Intravenous (IV) Antipseudomonal Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000', 'lowerLimit': '217', 'upperLimit': '316'}, {'value': '232', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '288'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Change in Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Temperature (Celsius) End of Treatment Course 1', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Temperature (Celsius) End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Temperature (Celsius) End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'Temperature was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Change in Respiratory Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'RR, End of Treatment Course 1', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'RR, End of Treatment Course 3', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'RR, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.02', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'RR was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.', 'unitOfMeasure': 'breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'WBCs, Baseline', 'categories': [{'measurements': [{'value': '9.28', 'spread': '3.692', 'groupId': 'OG000'}, {'value': '10.11', 'spread': '3.635', 'groupId': 'OG001'}]}]}, {'title': 'WBCs, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '9.47', 'spread': '3.998', 'groupId': 'OG000'}, {'value': '9.53', 'spread': '3.562', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Baseline', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Baseline', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.152', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Baseline', 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.623', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '0.732', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.801', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.719', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Baseline', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.241', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.210', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Baseline', 'categories': [{'measurements': [{'value': '6.54', 'spread': '3.295', 'groupId': 'OG000'}, {'value': '7.09', 'spread': '3.227', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '6.68', 'spread': '3.481', 'groupId': 'OG000'}, {'value': '6.63', 'spread': '3.345', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Baseline', 'categories': [{'measurements': [{'value': '293.11', 'spread': '85.681', 'groupId': 'OG000'}, {'value': '340.19', 'spread': '106.749', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '290.43', 'spread': '106.903', 'groupId': 'OG000'}, {'value': '311.39', 'spread': '98.370', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of Course 9 (Week 68)', 'unitOfMeasure': 'number of cells x10^3/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Basophils, Baseline', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.379', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.390', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.393', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.340', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Baseline', 'categories': [{'measurements': [{'value': '2.05', 'spread': '1.194', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '1.453', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '2.20', 'spread': '1.694', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '1.625', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Baseline', 'categories': [{'measurements': [{'value': '23.40', 'spread': '8.278', 'groupId': 'OG000'}, {'value': '22.74', 'spread': '8.265', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '22.30', 'spread': '7.462', 'groupId': 'OG000'}, {'value': '24.17', 'spread': '8.441', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Baseline', 'categories': [{'measurements': [{'value': '5.32', 'spread': '1.919', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '1.752', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '5.64', 'spread': '1.660', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '1.977', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Baseline', 'categories': [{'measurements': [{'value': '68.39', 'spread': '9.331', 'groupId': 'OG000'}, {'value': '69.26', 'spread': '9.261', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '69.02', 'spread': '8.551', 'groupId': 'OG000'}, {'value': '67.46', 'spread': '9.808', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'percent of differential', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Number of Red Blood Cells (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'RBCs, Baseline', 'categories': [{'measurements': [{'value': '5.15', 'spread': '0.442', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '0.499', 'groupId': 'OG001'}]}]}, {'title': 'RBCs, End of treatment 9', 'categories': [{'measurements': [{'value': '4.93', 'spread': '0.376', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '0.492', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'number x10^6/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Hematocrit, Baseline', 'categories': [{'measurements': [{'value': '43.43', 'spread': '4.037', 'groupId': 'OG000'}, {'value': '42.45', 'spread': '4.142', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit, End of treatment course 9', 'categories': [{'measurements': [{'value': '42.00', 'spread': '3.317', 'groupId': 'OG000'}, {'value': '41.63', 'spread': '4.056', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Hemoglobin, Baseline', 'categories': [{'measurements': [{'value': '14.06', 'spread': '1.406', 'groupId': 'OG000'}, {'value': '13.70', 'spread': '1.448', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, End of treatment course 9', 'categories': [{'measurements': [{'value': '13.89', 'spread': '1.195', 'groupId': 'OG000'}, {'value': '13.71', 'spread': '1.475', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Mean Corpuscular Volume (MCV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'MCV, Baseline', 'categories': [{'measurements': [{'value': '84.33', 'spread': '4.880', 'groupId': 'OG000'}, {'value': '86.08', 'spread': '5.560', 'groupId': 'OG001'}]}]}, {'title': 'MCV, End of treatment course 9', 'categories': [{'measurements': [{'value': '85.38', 'spread': '5.232', 'groupId': 'OG000'}, {'value': '87.72', 'spread': '5.450', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Mean Corpuscular Hemoglobin (MCH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'MCH, Baseline', 'categories': [{'measurements': [{'value': '27.43', 'spread': '1.824', 'groupId': 'OG000'}, {'value': '27.84', 'spread': '2.090', 'groupId': 'OG001'}]}]}, {'title': 'MCH, End of treatment course 9', 'categories': [{'measurements': [{'value': '28.35', 'spread': '2.282', 'groupId': 'OG000'}, {'value': '28.89', 'spread': '2.050', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'pg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'MCHC, Baseline', 'categories': [{'measurements': [{'value': '32.41', 'spread': '1.032', 'groupId': 'OG000'}, {'value': '32.34', 'spread': '1.228', 'groupId': 'OG001'}]}]}, {'title': 'MCHC, End of treatment course 9', 'categories': [{'measurements': [{'value': '33.13', 'spread': '1.272', 'groupId': 'OG000'}, {'value': '32.99', 'spread': '1.288', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'ALT, Baseline', 'categories': [{'measurements': [{'value': '31.21', 'spread': '22.343', 'groupId': 'OG000'}, {'value': '26.65', 'spread': '18.982', 'groupId': 'OG001'}]}]}, {'title': 'ALT, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '30.78', 'spread': '24.045', 'groupId': 'OG000'}, {'value': '27.81', 'spread': '21.794', 'groupId': 'OG001'}]}]}, {'title': 'AST, Baseline', 'categories': [{'measurements': [{'value': '27.83', 'spread': '14.856', 'groupId': 'OG000'}, {'value': '25.77', 'spread': '15.556', 'groupId': 'OG001'}]}]}, {'title': 'AST, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '26.84', 'spread': '14.588', 'groupId': 'OG000'}, {'value': '26.22', 'spread': '15.240', 'groupId': 'OG001'}]}]}, {'title': 'GGT, Baseline', 'categories': [{'measurements': [{'value': '35.49', 'spread': '48.215', 'groupId': 'OG000'}, {'value': '29.64', 'spread': '41.862', 'groupId': 'OG001'}]}]}, {'title': 'GGT, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '40.83', 'spread': '57.471', 'groupId': 'OG000'}, {'value': '32.39', 'spread': '39.662', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Calcium (EDTA), Baseline', 'categories': [{'measurements': [{'value': '9.67', 'spread': '0.406', 'groupId': 'OG000'}, {'value': '9.56', 'spread': '0.416', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (EDTA), End of Treatment Course 9', 'categories': [{'measurements': [{'value': '9.43', 'spread': '0.385', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.427', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Baseline', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.317', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.207', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.295', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin, Baseline', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, Baseline', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.298', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.294', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.377', 'groupId': 'OG001'}]}]}, {'title': 'Serum glucose, Baseline', 'categories': [{'measurements': [{'value': '115.46', 'spread': '55.211', 'groupId': 'OG000'}, {'value': '111.53', 'spread': '49.485', 'groupId': 'OG001'}]}]}, {'title': 'Serum glucose, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '121.11', 'spread': '57.47', 'groupId': 'OG000'}, {'value': '116.40', 'spread': '65.046', 'groupId': 'OG001'}]}]}, {'title': 'BUN, Baseline', 'categories': [{'measurements': [{'value': '14.65', 'spread': '4.258', 'groupId': 'OG000'}, {'value': '14.32', 'spread': '5.698', 'groupId': 'OG001'}]}]}, {'title': 'BUN, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '13.83', 'spread': '4.764', 'groupId': 'OG000'}, {'value': '14.49', 'spread': '4.805', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Chemistry - Concentration of Chloride, Potassium, and Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Serum chloride, Baseline', 'categories': [{'measurements': [{'value': '102.17', 'spread': '2.904', 'groupId': 'OG000'}, {'value': '102.22', 'spread': '2.943', 'groupId': 'OG001'}]}]}, {'title': 'Serum chloride, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '101.81', 'spread': '2.610', 'groupId': 'OG000'}, {'value': '102.16', 'spread': '2.977', 'groupId': 'OG001'}]}]}, {'title': 'Serum potassium, Baseline', 'categories': [{'measurements': [{'value': '4.20', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '0.370', 'groupId': 'OG001'}]}]}, {'title': 'Serum potassium, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '4.19', 'spread': '0.388', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Serum sodium, Baseline', 'categories': [{'measurements': [{'value': '139.18', 'spread': '2.984', 'groupId': 'OG000'}, {'value': '139.23', 'spread': '2.618', 'groupId': 'OG001'}]}]}, {'title': 'Serum sodium, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '138.64', 'spread': '2.608', 'groupId': 'OG000'}, {'value': '138.88', 'spread': '2.694', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}, {'type': 'PRIMARY', 'title': 'Serum Chemistry - Concentration of Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'OG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'classes': [{'title': 'Total protein, Baseline', 'categories': [{'measurements': [{'value': '7.63', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '7.58', 'spread': '0.536', 'groupId': 'OG001'}]}]}, {'title': 'Total protein, End of Treatment Course 9', 'categories': [{'measurements': [{'value': '7.47', 'spread': '0.425', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '0.560', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all enrolled participants who received one or more doses of AZLI.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'FG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'AE unrelated to study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Study drug intolerance (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'AE related to study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Personal or administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Open-label, Phase 3 follow-on study for participants from Studies CP-AI-005 (NCT00104520) and CP-AI-007 (NCT00112359). Participants were enrolled at 71 sites in the United States, Canada, Australia, and New Zealand. The date of first enrollment was 17 August 2005, and the date of database lock was 23 January 2009.', 'preAssignmentDetails': 'Participants enrolled in this study were required to have previously participated in CP-AI-005 or CP-AI-007. Participants from CP-AI-005 received open-label AZLI (75 mg) in the same regimen (twice daily \\[BID\\] or three times daily \\[TID\\]) to which they were previously randomized. Participants from CP-AI-007 received open-label AZLI (75 mg) TID.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '75 mg AZLI Two Times a Day (BID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nBID = twice daily'}, {'id': 'BG001', 'title': '75 mg AZLI Three Times a Day (TID)', 'description': 'Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.\n\nTID = three times daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Aztreonam Minimum Inhibitory Concentration (MIC) for Pseudomonas aeruginosa (PA)', 'classes': [{'title': 'Aztreonam MIC > 8 µg/mL', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'Aztreonam MIC < or = 8 µg/mL', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of partipipants with an MIC of aztreonam ≤ 8 µg/mL or \\>8 µg/mL for PA are summarized.', 'unitOfMeasure': 'participants'}, {'title': 'Disease severity as defined by FEV1 percent predicted category', 'classes': [{'title': 'FEV1 > 50% predicted', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': 'FEV1 ≤ 50% predicted', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. This baseline measure indicates the number of subjects with FEV1 greater than 50% and less than or equal to 50% of the predicted value based on age, gender, and height at screening.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '21.30', 'spread': '3.25', 'groupId': 'BG000'}, {'value': '21.44', 'spread': '3.96', 'groupId': 'BG001'}, {'value': '21.40', 'spread': '3.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS)', 'classes': [{'categories': [{'measurements': [{'value': '65.410', 'spread': '16.896', 'groupId': 'BG000'}, {'value': '60.332', 'spread': '18.497', 'groupId': 'BG001'}, {'value': '61.895', 'spread': '18.141', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CFQ-R RSS scale range 0-100, with higher scores indicating fewer CF symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted', 'classes': [{'categories': [{'measurements': [{'value': '56.711', 'spread': '17.505', 'groupId': 'BG000'}, {'value': '55.071', 'spread': '15.428', 'groupId': 'BG001'}, {'value': '55.582', 'spread': '16.089', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log10 Pseudomonas aeruginosa (PA) Colony-Forming Units (CFUs) in Sputum', 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '2.249', 'groupId': 'BG000'}, {'value': '6.16', 'spread': '1.894', 'groupId': 'BG001'}, {'value': '6.02', 'spread': '2.014', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 CFUs/g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '59.52', 'spread': '13.28', 'groupId': 'BG000'}, {'value': '59.28', 'spread': '15.81', 'groupId': 'BG001'}, {'value': '59.36', 'spread': '15.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2005-08-08', 'resultsFirstSubmitDate': '2010-06-03', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-16', 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events (AEs)', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.\n\nParticipants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period.'}, {'measure': 'Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.'}, {'measure': 'Change in Heart Rate (HR)', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'HR was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.'}, {'measure': 'Change in Systolic and Diastolic Blood Pressure (BP)', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'BP was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.'}, {'measure': 'Change in Temperature', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'Temperature was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.'}, {'measure': 'Change in Respiratory Rate (RR)', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)', 'description': 'RR was recorded at all visits.\n\nChange from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.'}, {'measure': 'Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets', 'timeFrame': 'Baseline and end of Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Number of Red Blood Cells (RBC)', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Hematocrit', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Hemoglobin', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Mean Corpuscular Volume (MCV)', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Mean Corpuscular Hemoglobin (MCH)', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Chemistry - Concentration of Chloride, Potassium, and Sodium', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}, {'measure': 'Serum Chemistry - Concentration of Total Protein', 'timeFrame': 'Baseline and end of treatment Course 9 (Week 68)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum', 'timeFrame': 'Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).\n\nDue to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.'}, {'measure': 'Number of Participants With Other Pathogens', 'timeFrame': 'Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)', 'description': 'Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive \\[MSSA\\] and methicillin-resistant \\[MRSA\\] S.aureus), and fungal organisms.\n\nNumber of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported.'}, {'measure': 'Minimum Inhibitory Concentration (MIC) of Aztreonam', 'timeFrame': 'Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)', 'description': 'The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.'}, {'measure': 'Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.\n\nFEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.\n\nThe percent change from baseline is presented for each endpoint.'}, {'measure': 'Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.'}, {'measure': 'Time to First Hospitalization Due to a Respiratory Event', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).\n\nTime to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored.'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)', 'description': 'Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.'}, {'measure': 'Missed School/Work Days Due to CF Symptoms', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.\n\nThe percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group.'}, {'measure': 'Time to Intravenous (IV) Antipseudomonal Antibiotics', 'timeFrame': 'Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug', 'description': 'Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'Pseudomonas aeruginosa'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).', 'detailedDescription': 'People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.\n\nA course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.\n* Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.\n* Ability to provide written informed consent/assent prior to initiation of study-related procedures.\n* Ability to perform reproducible pulmonary function tests.\n\nExclusion Criteria:\n\n* Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.\n* Concurrent participation in a study of another investigational drug or device.\n* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.\n* History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.\n* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.\n* Inability to tolerate study medication in CP-AI-005 or CP-AI-007.\n* Known local or systemic hypersensitivity to aztreonam.\n* Inability to tolerate inhalation of a short acting beta-2 agonist.\n* Abnormal renal or hepatic function based on results of most recent test.\n* Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.\n* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.'}, 'identificationModule': {'nctId': 'NCT00128492', 'acronym': 'AIR-CF3', 'briefTitle': 'Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)', 'orgStudyIdInfo': {'id': 'CP-AI-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AZLI 75 mg two times a day (BID)/ three times a day (TID)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Prahan', 'state': 'Victoria', 'country': 'Australia'}, {'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Auckland', 'country': 'New Zealand', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Bruce Montgomery, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Bresnik, MD, Director', 'oldOrganization': 'Clinical Research, Gilead Sciences, Inc.'}}}}