Study: NCT01675622

Adverse event: Respiratory and circulatory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 4 patients died of respiratory/circulatory failure due to progression of the underlying disease, which were not related to the study drug determined by the investigator
Frequency: 2 affected / 120 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 patient had ileus, which was possibly related to the study drug determined by the investigator, and the associated symptoms completely disappeared at the end of follow-up period.
Frequency: 1 affected / 120 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Nervous system disorders
Notes: 1 patient was hospitalized for brain metastases, which was unrelated to the study drug determined by the investigator, and the associated symptoms still persisted at the end of follow-up period;
Frequency: 1 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 120 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 120 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 120 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 120 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 120 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Low platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Respiratory and circulatory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 4 patients died of respiratory/circulatory failure due to progression of the underlying disease, which were not related to the study drug determined by the investigator
Frequency: 2 affected / 118 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 118 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 118 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 118 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 118 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 118 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 118 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 118 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 118 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 118 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 118 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 118 at risk