Study: NCT02280811

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

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

Adverse event: Infection (documented clinically and microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L)::Blood
Frequency: 1 affected / 1 at risk

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

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Obstruction/stenosis of airway::Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Prolonged intubation after pulmonary resection (>24 hrs after surgery)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
Frequency: 1 affected / 2 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
Frequency: 1 affected / 1 at risk

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

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: yes
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 2 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 6 at risk

Adverse event: Infection (documented clinically and microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L)::Blood
Frequency: 1 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Supraventricular and nodal arrhythmia::Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 2 affected / 2 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
Frequency: 2 affected / 2 at risk

Adverse event: Renal/Genitourinary - Other, Acute renal injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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