Study: NCT00544830

Adverse event: 10012727 -- Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10010300 -- Confusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10019483 -- Hemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 29 at risk

Adverse event: 10019483 -- Hemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10003658 -- Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10003668 -- Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040741 -- Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 29 at risk

Adverse event: 10019246 -- Hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10014695 -- Endocrine disorder
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10000081 -- Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10010774 -- Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10012727 -- Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 29 at risk

Adverse event: 10013950 -- Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10015461 -- Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10016766 -- Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10017944 -- Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10018286 -- Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10019611 -- Hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: 10028813 -- Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10036774 -- Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10036787 -- Proctoscopy abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10038064 -- Rectal hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10038072 -- Rectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10047700 -- Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10056848 -- Ear, nose and throat examination abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10065709 -- Rectal necrosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10012727 -- Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10028813 -- Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10008479 -- Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10016256 -- Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 29 at risk

Adverse event: 10016558 -- Fever
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10033371 -- Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10050068 -- Edema limbs
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: 90004082 -- Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10008531 -- Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10016558 -- Fever
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: 90004082 -- Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10020751 -- Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10021789 -- Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: 90031098 -- Upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: 90031102 -- Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: 10061103 -- Dermatitis radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 29 at risk

Adverse event: 10065892 -- Small intestinal anastomotic leak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: 10061103 -- Dermatitis radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: 10001551 -- Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: 10001675 -- Alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: 10003481 -- Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 29 at risk

Adverse event: 10011349 -- Creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10011368 -- Creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10025256 -- Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 29 at risk

Adverse event: 10029366 -- Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10035528 -- Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 29 at risk

Adverse event: 10040190 -- Serum cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10047896 -- Weight gain
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10048552 -- Leukocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 29 at risk

Adverse event: 10024384 -- Leukopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: 10025327 -- Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: 10035528 -- Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: 10002646 -- Anorexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10005557 -- Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 29 at risk

Adverse event: 10012174 -- Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040123 -- Serum albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040175 -- Serum calcium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 29 at risk

Adverse event: 10040268 -- Serum glucose decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10040336 -- Serum magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040378 -- Serum potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040379 -- Serum potassium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10040405 -- Serum sodium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040424 -- Serum triglycerides increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10054863 -- Serum sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10021018 -- Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10003246 -- Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10003988 -- Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 29 at risk

Adverse event: 10006002 -- Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10023222 -- Joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10028411 -- Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10028836 -- Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10031282 -- Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10033425 -- Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10013573 -- Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10019211 -- Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10029298 -- Neurological disorder NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10034620 -- Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10002855 -- Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10012378 -- Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10022437 -- Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10024419 -- Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10011781 -- Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10019591 -- Hemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10037020 -- Protein urine positive
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10038435 -- Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10046461 -- Urethral pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10046539 -- Urinary frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 29 at risk

Adverse event: 10046543 -- Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 29 at risk

Adverse event: 10046555 -- Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 29 at risk

Adverse event: 10046694 -- Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10046694 -- Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10034310 -- Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10036968 -- Prostatic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10061461 -- Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 29 at risk

Adverse event: 10018801 -- Gynecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10011224 -- Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10013963 -- Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10034844 -- Pharyngolaryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10035598 -- Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10047681 -- Voice alteration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10001760 -- Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10013786 -- Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: 10037087 -- Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10037853 -- Rash desquamating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 29 at risk

Adverse event: 10040831 -- Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10040865 -- Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: 10020407 -- Hot flashes
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 29 at risk

Adverse event: 10020772 -- Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10021097 -- Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: 10020407 -- Hot flashes
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk