Study: NCT00828984

Adverse event: Endocrine - Other (Specify, __)
Serious: no
Organ System: Endocrine disorders
Notes: Pancreatic Cancer
Frequency: 8 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Distention/bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastrointestinal - Other (Specify)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Urgency to have bowel movement
Frequency: 2 affected / 28 at risk

Adverse event: Pain: Abdomen Nos
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC: Bladder (Urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Perforation,GI: Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Edema; Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage, GI: Rectum
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 31 at risk

Adverse event: Endocrine - Other (Specify, __)
Serious: no
Organ System: Endocrine disorders
Notes: Pancreatic Cancer
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Distention/bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain: Pain Nos
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain - Other (Specify, __)
Serious: no
Organ System: General disorders
Notes: Sinus Headache Side Pain Body Ache Abdominal Pain
Frequency: 1 affected / 31 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain: Abdomen Nos
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain: Neuralgia/Peripheral Nerve
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain: Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: "Constitutional Symptoms: Fever (In the absence of Neutropenia, where Neutropenia is defined as ANC
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syndromes: Flu-like Syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Allergic Rhinitis (Including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 Neutrophils: Nerve-Peripheral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection with unknown ANC: Upper Airway Nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Notes: Recurrent Skin Boil
Frequency: 1 affected / 31 at risk

Adverse event: Infection with unknown ANC: Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 Neutrophils: Upper Airway Nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Musculoskeletal/Soft tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Plantar Fascitis
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary/Upper Respiratory: Nasal Cavity/Paranasal Sinus Reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary/Upper Respiratory: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrgae/Bleeding,CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Edema; Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac arrythmia: Supraventricular and nodal arrhythmia: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Otitis, Middle Ear (Non-Infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 28 at risk

Adverse event: Otitis, External Ear (Non-Infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Distention/bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Abdomen Nos
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Rectum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Chest/Thorax Nos
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain: Dental/Teeth/Peridontal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Constitutional Symptoms: Fatigue (Asthenia, Lethargy, Malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Allergic Rhinitis (Including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Infection with unknown ANC: Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 Neutrophils: Upper Airway Nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC: Skin (Cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: "Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils (ANC <1.0 X 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC: Nerve-Peripheral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC: Dental-tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Infection with unknown ANC: Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Musculoskeletal/Soft tissue - Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk