Study: NCT00512252

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 3 at risk

Adverse event: Allergic reaction - NOS
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Allergic reaction - general itching during transfusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Allergic reaction - platelet transfusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blurred vison
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bone marrow biopsy site pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Catheter site insertion pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Esophagus pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Hemorrhage - eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hemorrhage - nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Itching (pruritus)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Mucositis (oral and stomach)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Muscle weakness - generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neuropathy - face
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Opportunistic infection - urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes undefined rash, vaginal, lower extremities, left arm, and bilateral arms.
Frequency: 2 affected / 3 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Allergic reaction - general itching during transfusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 3 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3 at risk

Adverse event: Catheter site insertion pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Generalized pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Left lower abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Mucositis (oral and stomach)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Opportunistic infection (pneumonia NOS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes undefined rash, vaginal, lower extremities, left arm, and bilateral arms.
Frequency: 3 affected / 3 at risk

Adverse event: Right ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3 at risk

Adverse event: Right side pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Allergic reaction - platelet transfusion
Serious: yes
Organ System: Immune system disorders
Notes: Grade 5 - unlikely related
Frequency: 1 affected / 46 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 46 at risk

Adverse event: Infection-other (gram negative sepsis)
Serious: yes
Organ System: Infections and infestations
Notes: Grade 5 unrelated
Frequency: 1 affected / 46 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 46 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 46 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 46 at risk

Adverse event: Acute febrile neutrophilic dermatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 46 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 20 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 46 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 46 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 46 at risk

Adverse event: Bilateral extremity echymosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bilateral extremity petichiae
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Blurred vison
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 46 at risk

Adverse event: Bone marrow biopsy site pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 46 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 46 at risk

Adverse event: Bumps on legs and arms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Catheter site insertion pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 46 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 46 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 46 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Coccydynia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Cognitive disturbance - lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Colitis, infectious - clostridium difficile
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 46 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 46 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 46 at risk

Adverse event: Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 46 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 46 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 46 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 46 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 17 affected / 46 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Esophagus pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Facial pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Generalized bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 46 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: right arm and central line placement
Frequency: 4 affected / 46 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 17 affected / 46 at risk

Adverse event: Hemorrhage - eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hemorrhage - nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hemorrhoidal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 46 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 46 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 46 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 20 affected / 46 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 46 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 46 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 46 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 46 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Incisional pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 46 at risk

Adverse event: Incontinence - secondary to urinary urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Infection, gram positive cocci
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 46 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 46 at risk

Adverse event: Itching (pruritus)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 46 at risk

Adverse event: Jaundice - right eye
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Left arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Left elbow pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 38 affected / 46 at risk

Adverse event: Lip swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Liver abcess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Lower back wound pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Lower extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 46 at risk

Adverse event: Mood alteration (not specified)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Oral pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Mouth pain - right side
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Mucositis (oral and stomach)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 46 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Muscle weakness - generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 46 at risk

Adverse event: Nasal/paranasal reactions - sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 46 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Neuropathy (not specified)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - bilateral feet
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Neuropathy - bilateral hands
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - face
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - left eye droop
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - left hand
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - right ankle
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neuropathy - toes
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 21 affected / 46 at risk

Adverse event: Opportunistic infection (pneumonia NOS)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Opportunistic infection - urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Opportunistic infection, nasal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Pain upon inspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Perirectal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Petichiae
Serious: no
Organ System: General disorders
Frequency: 6 affected / 46 at risk

Adverse event: Pilonidal disease
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 23 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes undefined rash, vaginal, lower extremities, left arm, and bilateral arms.
Frequency: 10 affected / 46 at risk

Adverse event: Red and swollen left labia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right forearm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right head and neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right jaw pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Right side pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 46 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 46 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 46 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Vision - floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 46 at risk

Adverse event: Visual changes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 46 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Wound - coccyx
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Infection - gram negative sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Infection - gram negative bacilli
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk