Study: NCT01944774

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly related to the study drug
Frequency: 1 affected / 68 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Possibly related to the study drug
Frequency: 1 affected / 68 at risk

Adverse event: Worsening of congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly unrelated to the study drug
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly unrelated to the study drug for SAE occurred in subjects in the Nemonoxacin 650mg study group and definitely unrelated to the study drug for for SAE occurred in subjects in the Nemonoxacin 500mg study group
Frequency: 1 affected / 68 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 68 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 68 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 68 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 68 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 68 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Neutrophil percentage decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 68 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Alpha hydroxybutyrate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Prealbumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Electrocardiogram T wave amplitude decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 68 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 68 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infusion site discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infusion site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 68 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Supraventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Cardiac conduction disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Tinea manuum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Interstitial lung disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 68 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 68 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Bladder mass
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly unrelated to the study drug for SAE occurred in subjects in the Nemonoxacin 650mg study group and definitely unrelated to the study drug for for SAE occurred in subjects in the Nemonoxacin 500mg study group
Frequency: 1 affected / 67 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 67 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 67 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 67 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 67 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 67 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 67 at risk

Adverse event: Neutrophil percentage decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 67 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 67 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 67 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Lymphocyte percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Mean cell haemoglobin concentration decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Mean cell haemoglobin concentration increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Eosinophil percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Neutrophil percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Bile acids increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 67 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 67 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 67 at risk

Adverse event: Infusion site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Infusion site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 67 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Hyperchlorhydria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Supraventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cardiac conduction disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Definitely unrelated to the study drug
Frequency: 1 affected / 70 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 70 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 70 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Neutrophil percentage decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Monocyte percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Electrocardiogram ST-T change
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Mucous stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 70 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dysphemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Altered visual depth perception
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Spondyloarthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypoproteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 70 at risk

Adverse event: Leukopenias NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk