Study: NCT00493467

Adverse event: PERFORATION, GI
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Small bowel perforation
Frequency: 1 affected / 31 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 31 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 31 at risk

Adverse event: FEVER WITHOUT NEUTROPHIL INCREASE
Serious: no
Organ System: Investigations
Frequency: 4 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

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

Adverse event: HEMOGLOBIN INCREASE
Serious: no
Organ System: Investigations
Frequency: 12 affected / 31 at risk

Adverse event: HEMORRHAGE, PULMONARY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: INFECTION UNKNOWN
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: INFECTION WITHOUT NEUTROPHIL INCREASE
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 31 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: NEUROPATHY: SENSOR
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 31 at risk

Adverse event: NEUTROPHILS CHANGE (Absolute neutrophil count (ANC))
Serious: no
Organ System: Investigations
Frequency: 21 affected / 31 at risk

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

Adverse event: PAIN (ABDOMEN NOS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN (BACK)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN (HEAD/HEADACHES)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: PAIN (JOINT)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: PAIN (MUSCLE)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: PERFORATION, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: PLATELETS, DECREASE
Serious: no
Organ System: Investigations
Frequency: 21 affected / 31 at risk

Adverse event: PROPTOSIS/Enophthalmos
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue 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: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: THROMBOSIS/THROMBUS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk