Study: NCT00705874

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU)
Frequency: 3 affected / 12 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
Frequency: 2 affected / 12 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
Frequency: 2 affected / 12 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Notes: 1 unlikely related (Gemcitabine), 1 not related (Erlotinib), 1 not related (Cisplatin)
Frequency: 1 affected / 12 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin)
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 not related (Gemcitabine) and 1 unlikely related (5-FU)
Frequency: 1 affected / 12 at risk

Adverse event: Uncontrolled pain
Serious: yes
Organ System: General disorders
Notes: Not related (Gemcitabine)
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (Gemcitabine)
Frequency: 1 affected / 12 at risk

Adverse event: Right lower chest pain
Serious: yes
Organ System: General disorders
Notes: Not related (Gemcitabine)
Frequency: 1 affected / 12 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: 1 not related (Gemcitabine), unlikely related (1 Gemcitabine, 1 5-FU)
Frequency: 2 affected / 12 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (Gemcitabine)
Frequency: 1 affected / 12 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 1 not related and 1 related (Docetaxel)
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
Frequency: 1 affected / 9 at risk

Adverse event: Neutroponic fever
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Docetaxel), related (1 5-FU)
Frequency: 1 affected / 9 at risk

Adverse event: Deep vain thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Not related (1 Docetaxel), related (1 Cisplatin)
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Vascular device infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU)
Frequency: 2 affected / 34 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
Frequency: 3 affected / 34 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
Frequency: 2 affected / 34 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin)
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
Frequency: 3 affected / 34 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: 1 not related and 1 unlikely related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC
Serious: yes
Organ System: Infections and infestations
Notes: Not related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Superventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (1 Cisplatin), 1 unlikely related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin)
Frequency: 1 affected / 34 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 5-FU), unlikely related (2 Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Pain right hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Notes: Unlikely related (Bevacizumab)
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 34 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
Frequency: 2 affected / 34 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
Frequency: 2 affected / 34 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Notes: 1 unlikely related (Gemcitabine), 1 not related (Erlotinib), 1 not related (Cisplatin)
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
Frequency: 2 affected / 34 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin)
Frequency: 2 affected / 34 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related (2 Erlotinib, 2 Cisplatin), unlikely related (1 Cisplatin, 2 5-FU), related (1 Erlotinib, 2 Cisplatin)
Frequency: 3 affected / 34 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Cisplatin, 2 5-FU), unlikely related (1 Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (1 Cisplatin), related (1 Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Elevated bilirubin
Serious: yes
Organ System: Investigations
Notes: Not related (1 Erlotinib, 1 Cisplatin)
Frequency: 1 affected / 34 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin), related (1 Cisplatin)
Frequency: 2 affected / 34 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Erlotinib and 1Cisplatin)
Frequency: 1 affected / 34 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Not related (1 Erlotinib, 1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 34 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related (1 Erlotinib, 2 5-FU)
Frequency: 1 affected / 34 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related (Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related (Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Related (2 Erlotinib)
Frequency: 2 affected / 34 at risk

Adverse event: Metastatic rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (Erlotinib)
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 34 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 34 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 34 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
Frequency: 4 affected / 48 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
Frequency: 2 affected / 48 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Notes: 1 unlikely related (Gemcitabine), 1 not related (Erlotinib), 1 not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin)
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
Frequency: 1 affected / 48 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
Frequency: 1 affected / 48 at risk

Adverse event: Deep vain thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Not related (1 Docetaxel), related (1 Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Superventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (1 Cisplatin), 1 unlikely related (Bevacizumab)
Frequency: 1 affected / 48 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin)
Frequency: 2 affected / 48 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related (2 Erlotinib, 2 Cisplatin), unlikely related (1 Cisplatin, 2 5-FU), related (1 Erlotinib, 2 Cisplatin)
Frequency: 4 affected / 48 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Elevated creatinine
Serious: yes
Organ System: Investigations
Notes: Related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: 2 not related and 1 unlikely related (Cisplatin)
Frequency: 3 affected / 48 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Cisplatin, 2 5-FU), unlikely related (1 Erlotinib)
Frequency: 2 affected / 48 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (1 Cisplatin), related (1 Erlotinib)
Frequency: 1 affected / 48 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Not related and unlikely related (Cisplatin)
Frequency: 2 affected / 48 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: General disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Elevated bilirubin
Serious: yes
Organ System: Investigations
Notes: Not related (1 Erlotinib, 1 Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: Unlikely related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin), related (1 Cisplatin)
Frequency: 2 affected / 48 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related (1 Cisplatin), related (1 Cisplatin)
Frequency: 2 affected / 48 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Cisplatin), unlikely related (1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Increased confusion
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Tracheostomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Post operative trachea hemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Hypersensitivity allergic reaction
Serious: yes
Organ System: Immune system disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Ureteral obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (1 Cisplatin and 1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related (2 Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Erlotinib and 1Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not related (Cisplatin)
Frequency: 1 affected / 48 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Not related (1 Erlotinib, 1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 48 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 48 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 48 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 48 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 48 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU)
Frequency: 2 affected / 32 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
Frequency: 5 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
Frequency: 3 affected / 32 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin)
Frequency: 3 affected / 32 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 not related (Gemcitabine) and 1 unlikely related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: 1 not related (Gemcitabine), unlikely related (1 Gemcitabine, 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
Frequency: 1 affected / 32 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
Frequency: 2 affected / 32 at risk

Adverse event: Neutroponic fever
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Docetaxel), related (1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin)
Frequency: 1 affected / 32 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 5-FU), unlikely related (2 Bevacizumab)
Frequency: 2 affected / 32 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related (2 Erlotinib, 2 Cisplatin), unlikely related (1 Cisplatin, 2 5-FU), related (1 Erlotinib, 2 Cisplatin)
Frequency: 2 affected / 32 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related (Cisplatin)
Frequency: 1 affected / 32 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (2 Cisplatin, 2 5-FU), unlikely related (1 Erlotinib)
Frequency: 2 affected / 32 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related (1 Cisplatin), unlikely related (1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Increased confusion
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (1 Cisplatin and 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Not related (1 Erlotinib, 1 Cisplatin, 1 5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related (2 5-FU), related (5-FU)
Frequency: 2 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Unlikely related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Unlikely related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Intestinal ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related (1 Erlotinib, 2 5-FU)
Frequency: 2 affected / 32 at risk

Adverse event: Ogilvie syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Acute CVA
Serious: yes
Organ System: Nervous system disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Esophageal ulcers
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related (5-FU)
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 32 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hemorrhage CNS
Serious: yes
Organ System: Nervous system disorders
Notes: Related (Sunitinib)
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk