Study: NCT00011986

Adverse event: Allergy-Other
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 777 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 777 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 777 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 777 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 777 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 777 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 777 at risk

Adverse event: Cardiac-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 777 at risk

Adverse event: Constitutional Symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 777 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 777 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 777 at risk

Adverse event: Gi-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 777 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 777 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 777 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 777 at risk

Adverse event: Hematuria (In The Absence Of Vaginal Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 777 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 777 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 777 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 777 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 777 at risk

Adverse event: Seizure(S)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 777 at risk

Adverse event: Neuropathy-Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Neuropathy Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 777 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 777 at risk

Adverse event: Bone pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 777 at risk

Adverse event: Myalgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 777 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 777 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 777 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 746 affected / 862 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 821 affected / 862 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 319 affected / 862 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 508 affected / 862 at risk

Adverse event: Other Hemotologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 164 affected / 862 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 65 affected / 862 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 22 affected / 862 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 862 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 862 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 365 affected / 862 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 862 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 36 affected / 862 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 421 affected / 862 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 46 affected / 862 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 862 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 43 affected / 862 at risk

Adverse event: Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 135 affected / 862 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 118 affected / 862 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 862 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 117 affected / 862 at risk

Adverse event: Peripheral neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 207 affected / 862 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 42 affected / 862 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 317 affected / 862 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 104 affected / 861 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 862 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 70 affected / 862 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 774 at risk

Adverse event: Hearing-Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 774 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 774 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 774 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 774 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Vasovagal Episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 774 at risk

Adverse event: Cardiac-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 774 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 774 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 774 at risk

Adverse event: Rash/Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 774 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 774 at risk

Adverse event: Gi-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 774 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 774 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 774 at risk

Adverse event: Ascites (Non-Malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 774 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 774 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 774 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 774 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 774 at risk

Adverse event: Rectal Bleeding/Hematochezia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 774 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 774 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 774 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 774 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 774 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 774 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 774 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 774 at risk

Adverse event: Metabolic-Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 774 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 774 at risk

Adverse event: Hypomagnesmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 774 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 774 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 774 at risk

Adverse event: Mood Alteration-Anxiety Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 774 at risk

Adverse event: Neuropathy Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 774 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 774 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 774 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 774 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 774 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 774 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 774 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 774 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 826 affected / 860 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 838 affected / 860 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 675 affected / 860 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 700 affected / 860 at risk

Adverse event: Other Hemotologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 351 affected / 860 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 42 affected / 860 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 860 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 860 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 860 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 434 affected / 860 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 860 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 38 affected / 860 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 469 affected / 860 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 53 affected / 860 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 860 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 96 affected / 860 at risk

Adverse event: Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 196 affected / 860 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 98 affected / 860 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 860 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 135 affected / 860 at risk

Adverse event: Peripheral neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 232 affected / 860 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 54 affected / 860 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 301 affected / 860 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 129 affected / 860 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 860 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 94 affected / 860 at risk

Adverse event: Allergy-Other
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 767 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 767 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 767 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 767 at risk

Adverse event: Circulatory Or Cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Troponin I
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 767 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 767 at risk

Adverse event: Nodal/Junctional Arrhythmia/Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Arrhythmia- Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Cardiac-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 767 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 767 at risk

Adverse event: Wound-Non-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 767 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 767 at risk

Adverse event: Dyspepsia/Heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Ascites (Non-Malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 767 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 767 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 767 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 767 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 767 at risk

Adverse event: Hemorrhage/Bleeding With Grade 3 Or 4 Th
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 767 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Catheter-Related Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 767 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 767 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 767 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 767 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 767 at risk

Adverse event: Joint, Muscle, Or Bone-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 767 at risk

Adverse event: Speech Impairment- Dysphasia/Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 767 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 767 at risk

Adverse event: Neuropathy-Sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Neuropathy Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Chest Pain Non-Cardiac Or Non-Pleuritic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 767 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 767 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 767 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Fistula Or Gu Fistula
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 767 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 767 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 806 affected / 854 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 818 affected / 854 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 438 affected / 854 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 603 affected / 854 at risk

Adverse event: Other Hemotologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 261 affected / 854 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 54 affected / 854 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 23 affected / 854 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 62 affected / 854 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 854 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 403 affected / 854 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 109 affected / 854 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 41 affected / 854 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 496 affected / 854 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 56 affected / 854 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 854 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 42 affected / 854 at risk

Adverse event: Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 199 affected / 854 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 107 affected / 854 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 854 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 110 affected / 854 at risk

Adverse event: Peripheral neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 207 affected / 854 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 64 affected / 854 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 294 affected / 854 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 118 affected / 854 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 854 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 85 affected / 854 at risk

Adverse event: Allergy-Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 766 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 766 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 766 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 766 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 766 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 766 at risk

Adverse event: Cardiac-Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 766 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 766 at risk

Adverse event: Fever In The Absence Of Neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 766 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 766 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 766 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 766 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Gi-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 766 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 766 at risk

Adverse event: Dyspepsia/Heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Ascites (Non-Malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Fistula-Rectal/Anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 766 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 766 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 766 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 766 at risk

Adverse event: Hepatic-Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 766 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 766 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 766 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 766 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 766 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 766 at risk

Adverse event: Metabolic-Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 766 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 766 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 766 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 766 at risk

Adverse event: Mood Alteration-Anxiety Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 766 at risk

Adverse event: Dizziness/Lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 766 at risk

Adverse event: Chest Pain Non-Cardiac Or Non-Pleuritic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 766 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 766 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 766 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 766 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 766 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 782 affected / 846 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 830 affected / 846 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 460 affected / 846 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 647 affected / 846 at risk

Adverse event: Other Hemotologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 260 affected / 846 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 39 affected / 846 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 846 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 846 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 846 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 367 affected / 846 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 846 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 40 affected / 846 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 403 affected / 846 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 846 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 846 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 39 affected / 846 at risk

Adverse event: Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 143 affected / 846 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 846 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 846 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 90 affected / 846 at risk

Adverse event: Peripheral neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 134 affected / 846 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 846 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 295 affected / 846 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 106 affected / 846 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 846 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 74 affected / 846 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 767 at risk

Adverse event: Inner Ear/Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 767 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 767 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 767 at risk

Adverse event: Neutrophils/Granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Circulatory Or Cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 767 at risk

Adverse event: Arrhythmia- Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 767 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 767 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 767 at risk

Adverse event: Wound-Infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 767 at risk

Adverse event: Rash/Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 767 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 767 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 767 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Ascites (Non-Malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 767 at risk

Adverse event: Diarrhea (Without Colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 767 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 767 at risk

Adverse event: Rectal Bleeding/Hematochezia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hemorrhage/Bleeding Associated With Surgery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 767 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hepatic-Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 767 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 767 at risk

Adverse event: Infection Documented W Grd 3/4 Neutropn.
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 767 at risk

Adverse event: Infection Without Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 767 at risk

Adverse event: Febrile Neutropenia-Fuo Infect Not Docum
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 767 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 767 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 767 at risk

Adverse event: Seizure(S)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 767 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Cns Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 767 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 767 at risk

Adverse event: Dizziness/Lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Neuropathy Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 767 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 767 at risk

Adverse event: Pleural Effusion (Non-Malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 767 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 767 at risk

Adverse event: Operative Injury To Bladder/Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Renal/Gu-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 767 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 800 affected / 851 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 825 affected / 851 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 645 affected / 851 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 685 affected / 851 at risk

Adverse event: Other Hemotologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 327 affected / 851 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 47 affected / 851 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 851 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 851 at risk

Adverse event: Coagulation
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 851 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 363 affected / 851 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 851 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 27 affected / 851 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 399 affected / 851 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 42 affected / 851 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 851 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 79 affected / 851 at risk

Adverse event: Infection/Fever
Serious: no
Organ System: Infections and infestations
Frequency: 147 affected / 851 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 851 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 851 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 119 affected / 851 at risk

Adverse event: Peripheral neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 144 affected / 851 at risk

Adverse event: Ocular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 38 affected / 851 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 289 affected / 851 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 145 affected / 851 at risk

Adverse event: Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 851 at risk

Adverse event: 2nd Primary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 85 affected / 851 at risk