Study: NCT00567359

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Hepatic-other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Muco/stomatitis by exam- oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 100 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 100 at risk

Adverse event: Skin-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Tearing
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 100 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 100 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 5 affected / 100 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 63 affected / 100 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 100 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 100 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 100 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 100 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 100 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 74 affected / 100 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 100 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 100 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 100 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 100 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 100 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 100 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 100 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 7 affected / 100 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 7 affected / 100 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 8 affected / 100 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 100 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 100 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 100 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 100 at risk

Adverse event: Ocular-other
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 100 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Back, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 100 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 100 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 100 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 100 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 100 at risk