Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01799993
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'otherDetails': 'The PI will not make any publication of the results of the Study before the first multi-center publication, unless otherwise agreed upon by the Parties. In the event there is no multi-center publication within eighteen (18) months after a Study has been completed or terminated as all Study sites, Institution and/or Investigator shall have the right to publish the results from the Study at the Institution subject to the guideline laid out in the contacts.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'To shorten the time required to obtain data from the 2 clinical studies of Amikacin Inhale Phase 3 program, Bayer and the FDA decided that the results of studies NCT01799993 and NCT00805168 should be consolidated into a single report.'}}, 'adverseEventsModule': {'timeFrame': 'After the first dose of study drug and no later than 7 days after end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Amikacin Inhale 400mg q12h', 'description': 'Patients received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via PDDS Clinical from Day 1 to Day 10.', 'otherNumAtRisk': 353, 'deathsNumAtRisk': 353, 'otherNumAffected': 207, 'seriousNumAtRisk': 353, 'deathsNumAffected': 86, 'seriousNumAffected': 101}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients received 3.2 mL placebo solution aerosolized every 12 hours via PDDS Clinical from Day 1 to Day 10.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 214, 'seriousNumAtRisk': 359, 'deathsNumAffected': 85, 'seriousNumAffected': 97}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 49, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 34, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oesophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Sputum retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Reexpansion pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute interstitial pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Surviving Through LFU Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'title': 'Clinical Success (Survive)', 'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}, {'title': 'Clinical Failure (Did not survive)', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4263', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.841', 'ciLowerLimit': '0.554', 'ciUpperLimit': '1.277', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population (included all subjects who had a culture-confirmed Gram-negative bacteria that had been treated with at least one dose of study treatment, and had an APACHE II score ≥ 10 at the time of diagnosis of pneumonia)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'title': 'Pneumonia-related mortality', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Pneumonia-unrelated mortality', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6421', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who died through LFU visit in mITT population set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Early Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'title': 'Early Clinical Response - Success', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}, {'title': 'Early Clinical Response - Failure', 'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7984', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days after start of study treatment', 'description': 'Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Number of Days on Mechanical Ventilation Through LFU Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '10.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7144', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Number of Days in the ICU Through LFU Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '7.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4278', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population without missing start or end dates'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Microbiological Response Per Pathogen at TOC Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'title': 'Achromobacter xylosoxidans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Acinetobacter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acinetobacter anitratus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Acinetobacter junii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Burkholderia cepacia complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chryseobacterium indologenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter farmeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter freundii complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Corynebacterium argentoratense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corynebacterium propinquum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corynebacterium striatum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elizabethkingia meningoceptica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Ewingella americana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haemophilus influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Haemophilus parahaemolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemophilus parainfluenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hafnia alvei', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Kerstersia gyiorum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Kluyvera intermedia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moraxella catarrhalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neisseria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pantoea agglomerans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pasteurella multocida', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas putida', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Raoultella planticola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus haemolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus agalactiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus anginosus group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus mitis group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 17-19 days after start of study treatment', 'description': 'The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure \\[TOC\\] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Microbiological Response at TOC Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 17-19 days after start of study treatment', 'description': 'The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Microbiological Recurrence at LFU Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as "recurrence". Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days after start of study treatment', 'description': 'New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Emergence of Resistance Among Pathogens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population participants with pathogen susceptible to amikacin in pre-treatment period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': 'AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT for Safety population (included all participants in ITT analysis set who were analyzed as treated for safety analyses)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': 'AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: AE resulting in following outcomes or deemed significant for any reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent; significant disability/incapacity; congenital anomaly/birth defect; medical important serious event judged by investigator. SAEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent SAEs (TESAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT for Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Organ Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': "The overall number of participants with any organ failure was summarized for each treatment group. Organ failure was defined by a specific organ type and by a collection of MedDRA version 20.0 preferred terms that were determined by the sponsor's clinical team. A participant with multiple AEs within a system organ class or preferred term is counted a single time for that system organ class (SOC) or preferred term.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT for Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Death Due to Any Reason Through Day 10 and Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'classes': [{'title': 'Number of death through Day 10', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Number of death through Day 15', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days and 15 days after start of study treatment, respectively', 'description': 'Number of deaths due to any reason through Day 10 and Day 15 were summarized for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '358'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'comment': 'Completed follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '128'}]}], 'dropWithdraws': [{'type': 'Didn\'t complete CRF page "End of FU"', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by parent/guardian/LAR', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol driven decision point', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Deterioration of general conditions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Recovery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Logistical difficulties', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with medical device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Subject didn't return for follow-up", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'To shorten the time required to obtain data from the 2 clinical studies of Amikacin Inhale Phase 3 program, Bayer and the FDA decided that the results of studies NCT01799993 and NCT00805168 should be consolidated into a single report. The studies were conducted at 166 centers across 25 countries, between 13 APR 2013 (FPFV) and 07 APR 2017 (LPLV).', 'preAssignmentDetails': 'A total of 807 participants were screened, of which 725 participants were randomized for the 2 studies (264 for NCT01799993 and 461 for NCT00805168), 712 participants were treated with study treatment per exposure data in EDC; 354 received aerosolized amikacin inhale and 358 received placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '712', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amikacin Inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '15.78', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '17.04', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '16.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<18', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '18 to <45', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': '45 to <65', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': '65 to <75', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': '>=75', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'APACHE II score', 'classes': [{'categories': [{'title': '<20', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': '>=20', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Acute Physiology and Chronic Health Evaluation II (APACHE II) is a severity of disease classification system (Knaus et al, 1985), one of several ICU scoring systems. After admission of a patient to an ICU, an integer score from 0 to 71 is computed based on several measurements; higher scores imply a more severe disease and a higher risk of death. Participants who met all of the inclusion criteria and none of the exclusion criteria were stratified by geographic region (or country) and disease severity using APACHE II score, and randomized in a 1:1 ratio to one of the two treatment groups.', 'unitOfMeasure': 'Participants'}, {'title': 'CPIS', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.38', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '1.29', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '1.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinical Pulmonary Infection Score (CPIS) is an accepted tool for clinical estimation of ventilator-associated pneumonia (VAP), encompassing five components: tracheal secretions (volume and purulence), temperature, blood leukocytes, oxygenation (P/F ratio). An integer point score from 0 to 2 is assigned for each component; the total CPIS point score (ranges from 0 to 10) is calculated as the sum of the five components ; higher scores imply a more severe disease.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population (included all subjects who were treated with at least one dose of study drug)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-29', 'size': 2208892, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-14T22:16', 'hasProtocol': True}, {'date': '2017-11-03', 'size': 513627, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-14T22:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 725}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2013-02-25', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-14', 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Microbiological Response Per Pathogen at TOC Visit', 'timeFrame': 'Up to 17-19 days after start of study treatment', 'description': 'The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure \\[TOC\\] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.'}, {'measure': 'Number of Participants With Microbiological Response at TOC Visit', 'timeFrame': 'Up to 17-19 days after start of study treatment', 'description': 'The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.'}, {'measure': 'Number of Participants With Microbiological Recurrence at LFU Visit', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as "recurrence". Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.'}, {'measure': 'Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period', 'timeFrame': 'Up to 10 days after start of study treatment', 'description': 'New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group.'}, {'measure': 'Number of Participants With Emergence of Resistance Among Pathogens', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used.'}, {'measure': 'Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': 'AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).'}, {'measure': 'Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': 'AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: AE resulting in following outcomes or deemed significant for any reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent; significant disability/incapacity; congenital anomaly/birth defect; medical important serious event judged by investigator. SAEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent SAEs (TESAEs).'}, {'measure': 'Number of Participants With Organ Failure', 'timeFrame': 'Up to 7 days after the end of study treatment', 'description': "The overall number of participants with any organ failure was summarized for each treatment group. Organ failure was defined by a specific organ type and by a collection of MedDRA version 20.0 preferred terms that were determined by the sponsor's clinical team. A participant with multiple AEs within a system organ class or preferred term is counted a single time for that system organ class (SOC) or preferred term."}, {'measure': 'Number of Death Due to Any Reason Through Day 10 and Day 15', 'timeFrame': 'Up to 10 days and 15 days after start of study treatment, respectively', 'description': 'Number of deaths due to any reason through Day 10 and Day 15 were summarized for each treatment group.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Surviving Through LFU Visit', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.'}, {'measure': 'Number of Participants With Early Clinical Response', 'timeFrame': 'Up to 10 days after start of study treatment', 'description': 'Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.'}, {'measure': 'Number of Days on Mechanical Ventilation Through LFU Visit', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.'}, {'measure': 'Number of Days in the ICU Through LFU Visit', 'timeFrame': 'Up to 28-32 days after start of study treatment', 'description': 'Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gram-negative pneumonia', 'Intubation', 'Mechanical ventilation', 'Amikacin'], 'conditions': ['Pneumonia, Bacterial']}, 'referencesModule': {'references': [{'pmid': '31866328', 'type': 'DERIVED', 'citation': 'Niederman MS, Alder J, Bassetti M, Boateng F, Cao B, Corkery K, Dhand R, Kaye KS, Lawatscheck R, McLeroth P, Nicolau DP, Wang C, Wood GC, Wunderink RG, Chastre J. Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial. Lancet Infect Dis. 2020 Mar;20(3):330-340. doi: 10.1016/S1473-3099(19)30574-2. Epub 2019 Dec 19.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females, 18 years of age or older\n* Intubated and mechanically-ventilated\n* Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph\n* Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen\n* Impaired oxygenation\n* Clinical Pulmonary Infection Score (CPIS) of at least 6\n* Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms\n\nExclusion Criteria:\n\n* History of hypersensitivity to amikacin or other aminoglycosides\n* Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization\n* Known or suspected bacteremia secondary to Staphylococcus aureus\n* A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test\n* Patients with a serum creatinine \\> 2 mg/dL (177 µmol/L) \\[Exception: Patients with a serum creatinine \\> 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\\]\n* Has been on mechanical ventilation for \\> 28 days\n* Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment\n* The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy\n* Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score \\< 10\n* Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)'}, 'identificationModule': {'nctId': 'NCT01799993', 'acronym': 'INHALE 1', 'briefTitle': 'Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia', 'nctIdAliases': ['NCT00805168'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia', 'orgStudyIdInfo': {'id': '13084'}, 'secondaryIdInfos': [{'id': '2013-001048-73', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amikacin inhale (BAY41-6551)', 'description': 'Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.', 'interventionNames': ['Drug: Amikacin Inhalation Solution (BAY41-6551)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.', 'interventionNames': ['Drug: Aerosolized Placebo']}], 'interventions': [{'name': 'Amikacin Inhalation Solution (BAY41-6551)', 'type': 'DRUG', 'description': '400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)', 'armGroupLabels': ['Amikacin inhale (BAY41-6551)']}, {'name': 'Aerosolized Placebo', 'type': 'DRUG', 'description': 'Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85008-4956', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33021-5421', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606-3508', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '41701', 'city': 'Hazard', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.24954, 'lon': -83.19323}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '65803', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10065', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'geoPoint': 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