Study: NCT00705653

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 unrelated to PG-11047; 2 unlikely related to PG-11047
Frequency: 3 affected / 46 at risk

Adverse event: Alteration in mental status
Serious: yes
Organ System: Nervous system disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 2 possibly related to PG-11047
Frequency: 2 affected / 46 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Probably related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonitis aspiration
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 unrelated to PG-11047; 4 unlikely related to PG-11047
Frequency: 4 affected / 46 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated to PG-011047
Frequency: 1 affected / 46 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Probably related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Duodenal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 unrelated to PG-11047; 4 unlikely related to PG-11047; 2 possibly related to PG-11047
Frequency: 7 affected / 46 at risk

Adverse event: Elevated amylase
Serious: yes
Organ System: Investigations
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Elevated bilirubin
Serious: yes
Organ System: Investigations
Notes: 1 unrelated to PG-11047; 1 unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Elevated lipase
Serious: yes
Organ System: Investigations
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Gram negative bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Notes: 2 unlikely related to PG-11047
Frequency: 2 affected / 46 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Progressive disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: 2 unrelated to PG-11047, 1 unlikely related to PG-11047
Frequency: 3 affected / 46 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Right arm pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to PG-11047
Frequency: 1 affected / 46 at risk

Adverse event: Vomitting
Serious: yes
Organ System: General disorders
Notes: 1 unrelated to PG-11047; 2 unlikely related to PG-11047
Frequency: 2 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 46 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 46 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Parasethesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 46 at risk

Adverse event: dysponea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk