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Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Wound infection 0 0 1 1 1 1 0 0
Arthritis infective 0 0 0 0 0 0 1 1
Bronchopneumonia 0 0 0 0 0 0 1 1
Clostridium difficile colitis 0 0 0 0 0 0 3 3
Cytomegalovirus viremia 0 0 0 0 0 0 1 1
Febrile cold (excl flu like illness) 0 0 0 0 0 0 1 1
Febrile infection 0 0 0 0 0 0 1 1
GI infection 0 0 0 0 0 0 1 1
Infection pseudomonas aeruginosa 0 0 0 0 0 0 1 1
MRSA colonization 0 0 0 0 0 0 1 1
MRSA wound infection 0 0 0 0 0 0 1 1
Pneumonia aspergillus 0 0 0 0 0 0 1 1
Septic joint 0 0 0 0 0 0 1 1
Suppurative peritonitis, other 0 0 0 0 0 0 1 1
Respiratory, thoracic and mediastinal 44 58 52 85 96 143 32 40
disorders (16.3%) (18.6%) (17.5%) (9.2%)
Dyspnea 16 23 19 24 35 47 10 10
Respiratory failure 6 6 11 11 17 17 2 2
COPD exacerbation 4 4 11 20 15 24 5 5
Pleural effusion 3 3 3 4 6 7 3 3
Shortness of breath 4 4 2 3 6 7 0 0
Aspiration pneumonia 2 2 1 1 3 3 1 1
Epistaxis 0 0 3 3 3 3 2 2
Pulmonary hypertension 2 3 1 1 3 4 2 2
Respiratory distress 3 3 0 0 3 3 0 0
COPD 1 1 1 1 2 2 0 0
Dyspnea exertional 1 1 1 1 2 2 0 0
Hypoxemia 0 0 2 2 2 2 0 0
Pneumonitis 0 0 2 2 2 2 0 0
Pulmonary edema 0 0 2 2 2 2 1 1
Pulmonary infiltration 0 0 2 2 2 2 1 1
Pulmonary thromboembolism 2 2 0 0 2 2 0 0
Acute respiratory failure 0 0 1 1 1 1 0 0
Apnea 1 1 0 0 1 1 0 0
Asthma 1 1 0 0 1 1 0 0
Asthma aggravated 0 0 1 1 1 1 0 0
Bronchitis asthmatic 0 0 1 1 1 1 0 0
Difficulty breathing 0 0 1 1 1 1 0 0
Dyspnea exacerbated 1 1 0 0 1 1 0 0
Exacerbation of asthma 0 0 1 1 1 1 0 0
Hemoptysis 0 0 1 1 1 1 1 3
Hypoxia 0 0 1 1 1 1 3 3
Productive cough 0 0 1 1 1 1 0 0
Pulmonary mass 1 1 0 0 1 1 0 0
Respiratory arrest 1 2 0 0 1 2 0 0
Chronic obstructive pulmonary disease 0 0 0 0 0 0 3 3
Cough 0 0 0 0 0 0 1 1
Hypoventilation 0 0 0 0 0 0 1 1
Pulmonary embolus 0 0 0 0 0 0 1 1
Tachypnea 0 0 0 0 0 0 1 1
General disorders and administration site 35 43 30 40 65 83 36 46
conditions (13.0%) (10.7%) (11.8%) (10.4%)
Chest pain 16 20 10 11 26 31 17 26
Weakness 3 5 7 7 10 12 0 0

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