Study: NCT00184093

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhea patients without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 35 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 35 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 35 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Rectal or perirectal pain (proctalgia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 35 at risk

Adverse event: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 35 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 35 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 35 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 35 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 35 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Auditory/Hearing-Other (not specified)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 35 at risk

Adverse event: Constitutional Symptoms-Other (not specified)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 35 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 35 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 35 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Dysuria (painful urination)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 35 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 35 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 35 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 35 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 35 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 35 at risk

Adverse event: Inner ear/hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 35 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 35 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Melena/GI bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Middle ear/hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 35 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 35 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 31 affected / 35 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 35 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 35 at risk

Adverse event: Pain-Other (specify, pelvic)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 35 at risk

Adverse event: Pigmentation changes (e.g., vitiligo)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 35 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 35 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 35 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 35 at risk

Adverse event: Rectal or perirectal pain (proctalgia)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 35 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 35 at risk

Adverse event: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 35 at risk

Adverse event: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 21 affected / 35 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 35 at risk

Adverse event: Stomatitis/pharyngitis (ora/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Tumor pain (onset or exacerbation of tumor pain due to treatment)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 35 at risk