Study: NCT00700011

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 4 patients (40%) were affected by this SAE with a total of 6 episodes out of 22 total cycles (27%)
Frequency: 2 affected / 8 at risk

Adverse event: Infection w/ a Grade 3-4 ANC
Serious: yes
Organ System: Infections and infestations
Notes: 5 patients (50%) were affected by this SAE with a total of 8 episodes out of 22 total cycles (36%)
Frequency: 4 affected / 8 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Infection w/ Normal ANC
Serious: yes
Organ System: Infections and infestations
Notes: 1 patients (10%) were affected by this SAE with a total of 2 episodes out of 22 total cycles (9%)
Frequency: 1 affected / 8 at risk

Adverse event: Hemorrhage - Nosebleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Infection w/ Grade 1-2 ANC
Serious: yes
Organ System: Infections and infestations
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Pulmonary Infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Infection - Skin (cellulitis)
Serious: yes
Organ System: Investigations
Notes: 1 patients (10%) were affected by this SAE with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 50% of all patients had significant fatigue of grade 2 or above with 7 episodes out of 22 total cycles (32%).
Frequency: 4 affected / 8 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 4 episodes out of 22 total cycles (18%)
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 patients (30%) were affected by this of grade 2 or higher with a total of 3 episodes out of 22 total cycles (14%)
Frequency: 3 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 patients (30%) were affected by this of grade 2 or higher with a total of 3 episodes out of 22 total cycles (14%)
Frequency: 3 affected / 8 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 2 episodes out of 22 total cycles (9%)
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 2 episodes out of 22 total cycles (9%)
Frequency: 1 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 8 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 4 patients (40%) were affected by this SAE with a total of 6 episodes out of 22 total cycles (27%)
Frequency: 2 affected / 2 at risk

Adverse event: Infection w/ a Grade 3-4 ANC
Serious: yes
Organ System: Infections and infestations
Notes: 5 patients (50%) were affected by this SAE with a total of 8 episodes out of 22 total cycles (36%)
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 50% of all patients had significant fatigue of grade 2 or above with 7 episodes out of 22 total cycles (32%).
Frequency: 1 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 4 episodes out of 22 total cycles (18%)
Frequency: 1 affected / 2 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 2 episodes out of 22 total cycles (9%)
Frequency: 1 affected / 2 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 patients (20%) were affected by this of grade 2 or higher with a total of 2 episodes out of 22 total cycles (9%)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 2 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patients (10%) were affected by this of grade 2 or higher with a total of 1 episodes out of 22 total cycles (4.5%)
Frequency: 1 affected / 2 at risk