Study: NCT01142401

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: CTCAE Grade 5, unrelated to study drug
Frequency: 1 affected / 59 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CTCAE Grade 3
Frequency: 1 affected / 59 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 59 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim Terms: Depression, Seasonal Depression
Frequency: 5 affected / 59 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 59 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 59 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 59 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 59 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 59 at risk

Adverse event: SGOT_AST-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 59 at risk

Adverse event: SGPT_ALT-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 59 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 59 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 59 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory
Frequency: 18 affected / 59 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 59 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 59 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 59 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 59 at risk

Adverse event: Limb Edema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 59 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 22 affected / 59 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 59 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 59 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Absolute Neutrophil Count - low (Verbatim Term)
Frequency: 6 affected / 59 at risk

Adverse event: Infection with unknown Absolute Neutrophil Count
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 5 affected / 59 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Verbatim Term - Rigors/chills
Frequency: 4 affected / 59 at risk

Adverse event: Creatinine-Low
Serious: no
Organ System: Investigations
Notes: Verbatim Term
Frequency: 2 affected / 59 at risk

Adverse event: Total Bilirubin Low
Serious: no
Organ System: Investigations
Notes: Verbatim Term
Frequency: 3 affected / 59 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 59 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Terms: Chronic Kidney Disease, Chronic Renal Disease
Frequency: 1 affected / 59 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 59 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Verbatim Terms: Flu Like Symptoms, Flu Symptoms, Flu Like Feeling
Frequency: 2 affected / 59 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure
Frequency: 7 affected / 59 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)
Frequency: 5 affected / 59 at risk

Adverse event: Numbness - fingers
Serious: no
Organ System: Nervous system disorders
Notes: General finger/hand numbness due to either Reynaud's syndrome or carpal tunnel
Frequency: 4 affected / 59 at risk

Adverse event: Rash (General, not otherwise specified)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)
Frequency: 4 affected / 59 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 59 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Laryngeal Inflammation, Sore Throat
Frequency: 2 affected / 59 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Eye Disorders (not otherwise specified)
Serious: no
Organ System: Eye disorders
Notes: Verbatim Terms: Stye(s), Eyelid Function Disorder, Sore on Eyelid/Pruritis, Watering Eyes, Excessive Tearing (Right Eye), Glaucoma, Periocular Swelling, Cellulitis (Right Eye), Eye Infection (System Organ Class: Infections and Infestations)
Frequency: 4 affected / 59 at risk

Adverse event: Urinary Disorders (General)
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Terms: Urinary Frequency, Urinary Incontinence, Urinary Retention, Urinary Tract Obstruction, Urinary Urgency, Urine Odor, Urinary Tract Infection (System Organ Class: Infections and Infestations)
Frequency: 9 affected / 59 at risk

Adverse event: Reproductive system and breast disorders (General)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Verbatim Terms: Vaginal Discharge, Vaginal Dryness, Vaginal Hemorrhage, Vaginal Odor, Vulval Infection (System Organ Class: Infections and Infestations), Vaginal Infection (System Organ Class: Infections and Infestations), Bacterial Vaginosis
Frequency: 5 affected / 59 at risk

Adverse event: Upper Respiratory Disorders (General)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim: Allergic Rhinitis, Nasal Congestion, Sinus Disorder/Common Cold, Sinus Congestion, Rhinorrhea, Seasonal Allergies (sinus). Sinusitis, Respiratory Infection and Upper Respiratory Infection (System Organ Class: Infections and Infestations)
Frequency: 7 affected / 59 at risk

Adverse event: Lower Respiratory Disorders (General, not otherwise specified)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)
Frequency: 4 affected / 59 at risk

Adverse event: Ear Disorders (General)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)
Frequency: 2 affected / 59 at risk

Adverse event: Skin Infections (General)
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site
Frequency: 3 affected / 59 at risk

Adverse event: Infections (General), not otherwise specified
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes
Frequency: 3 affected / 59 at risk

Adverse event: Musculoskeletal Pain Disorders (not otherwise specified)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim: Generalized Muscle Weakness, Muscle Cramping, Muscle Spasms, Muscle Tension, Muscle Cramping - back, Muscle Weakness - lower limb, Pain - left deltoid muscle, Leg Cramps, Leg Pain, Bone Pain, Jaw Clicking, Osteonecrosis-Jaw, Neck Tightness
Frequency: 10 affected / 59 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Verbatim Terms: Sinus Tachycardia, Rapid Heartbeat
Frequency: 2 affected / 59 at risk

Adverse event: Carcinomas
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Terms: Basal Cell Carcinoma, Squamous Cell Carcinoma
Frequency: 3 affected / 59 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 59 at risk

Adverse event: White Blood Cells Decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 59 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 59 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 2 affected / 57 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 57 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CTCAE Grade 4
Frequency: 1 affected / 57 at risk

Adverse event: Cardiac Disorder (Unspecified)
Serious: yes
Organ System: Cardiac disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 57 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 57 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 57 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim Terms: Depression, Seasonal Depression
Frequency: 9 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 57 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 57 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 57 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 57 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 57 at risk

Adverse event: SGOT_AST-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 57 at risk

Adverse event: SGPT_ALT-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 57 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 57 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 57 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 57 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 57 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 57 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory
Frequency: 28 affected / 57 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 57 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 57 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 57 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 57 at risk

Adverse event: Limb Edema
Serious: no
Organ System: General disorders
Frequency: 21 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 57 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 57 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 18 affected / 57 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 57 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 57 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Absolute Neutrophil Count - low (Verbatim Term)
Frequency: 7 affected / 57 at risk

Adverse event: Infection with unknown Absolute Neutrophil Count
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 4 affected / 57 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Verbatim Term - Rigors/chills
Frequency: 4 affected / 57 at risk

Adverse event: Creatinine-Low
Serious: no
Organ System: Investigations
Notes: Verbatim Term
Frequency: 3 affected / 57 at risk

Adverse event: Total Bilirubin Low
Serious: no
Organ System: Investigations
Notes: Verbatim Term
Frequency: 1 affected / 57 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Verbatim Terms: Blurred Vision, Vision Changes
Frequency: 5 affected / 57 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 57 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Dysgeusia, Taste Changes
Frequency: 3 affected / 57 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 57 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Verbatim Terms: Flu Like Symptoms, Flu Symptoms, Flu Like Feeling
Frequency: 3 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure
Frequency: 12 affected / 57 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)
Frequency: 6 affected / 57 at risk

Adverse event: Rash (General, not otherwise specified)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)
Frequency: 13 affected / 57 at risk

Adverse event: Pressure - left pubic area
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Term
Frequency: 4 affected / 57 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 57 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Laryngeal Inflammation, Sore Throat
Frequency: 5 affected / 57 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Eye Disorders (not otherwise specified)
Serious: no
Organ System: Eye disorders
Notes: Verbatim Terms: Stye(s), Eyelid Function Disorder, Sore on Eyelid/Pruritis, Watering Eyes, Excessive Tearing (Right Eye), Glaucoma, Periocular Swelling, Cellulitis (Right Eye), Eye Infection (System Organ Class: Infections and Infestations)
Frequency: 7 affected / 57 at risk

Adverse event: Urinary Disorders (General)
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Terms: Urinary Frequency, Urinary Incontinence, Urinary Retention, Urinary Tract Obstruction, Urinary Urgency, Urine Odor, Urinary Tract Infection (System Organ Class: Infections and Infestations)
Frequency: 6 affected / 57 at risk

Adverse event: Reproductive system and breast disorders (General)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Verbatim Terms: Vaginal Discharge, Vaginal Dryness, Vaginal Hemorrhage, Vaginal Odor, Vulval Infection (System Organ Class: Infections and Infestations), Vaginal Infection (System Organ Class: Infections and Infestations), Bacterial Vaginosis
Frequency: 1 affected / 57 at risk

Adverse event: Upper Respiratory Disorders (General)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim: Allergic Rhinitis, Nasal Congestion, Sinus Disorder/Common Cold, Sinus Congestion, Rhinorrhea, Seasonal Allergies (sinus). Sinusitis, Respiratory Infection and Upper Respiratory Infection (System Organ Class: Infections and Infestations)
Frequency: 13 affected / 57 at risk

Adverse event: Lower Respiratory Disorders (General, not otherwise specified)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)
Frequency: 1 affected / 57 at risk

Adverse event: Ear Disorders (General)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)
Frequency: 1 affected / 57 at risk

Adverse event: Skin Infections (General)
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site
Frequency: 3 affected / 57 at risk

Adverse event: Infections (General), not otherwise specified
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes
Frequency: 4 affected / 57 at risk

Adverse event: Musculoskeletal Pain Disorders (not otherwise specified)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim: Generalized Muscle Weakness, Muscle Cramping, Muscle Spasms, Muscle Tension, Muscle Cramping - back, Muscle Weakness - lower limb, Pain - left deltoid muscle, Leg Cramps, Leg Pain, Bone Pain, Jaw Clicking, Osteonecrosis-Jaw, Neck Tightness
Frequency: 10 affected / 57 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 57 at risk

Adverse event: White Blood Cells Decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 57 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 57 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 27 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: CTCAE Grade 3
Frequency: 1 affected / 27 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CTCAE Grade 3
Frequency: 2 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 27 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim Terms: Depression, Seasonal Depression
Frequency: 5 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 27 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: SGOT_AST-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 27 at risk

Adverse event: SGPT_ALT-High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 27 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 27 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory
Frequency: 8 affected / 27 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 27 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 27 at risk

Adverse event: Limb Edema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Infection with unknown Absolute Neutrophil Count
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 1 affected / 27 at risk

Adverse event: Total Bilirubin Low
Serious: no
Organ System: Investigations
Notes: Verbatim Term
Frequency: 1 affected / 27 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Verbatim Terms: Blurred Vision, Vision Changes
Frequency: 1 affected / 27 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Terms: Chronic Kidney Disease, Chronic Renal Disease
Frequency: 2 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Dysgeusia, Taste Changes
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure
Frequency: 8 affected / 27 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)
Frequency: 3 affected / 27 at risk

Adverse event: Rash (General, not otherwise specified)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)
Frequency: 3 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Eye Disorders (not otherwise specified)
Serious: no
Organ System: Eye disorders
Notes: Verbatim Terms: Stye(s), Eyelid Function Disorder, Sore on Eyelid/Pruritis, Watering Eyes, Excessive Tearing (Right Eye), Glaucoma, Periocular Swelling, Cellulitis (Right Eye), Eye Infection (System Organ Class: Infections and Infestations)
Frequency: 3 affected / 27 at risk

Adverse event: Urinary Disorders (General)
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Terms: Urinary Frequency, Urinary Incontinence, Urinary Retention, Urinary Tract Obstruction, Urinary Urgency, Urine Odor, Urinary Tract Infection (System Organ Class: Infections and Infestations)
Frequency: 2 affected / 27 at risk

Adverse event: Reproductive system and breast disorders (General)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Verbatim Terms: Vaginal Discharge, Vaginal Dryness, Vaginal Hemorrhage, Vaginal Odor, Vulval Infection (System Organ Class: Infections and Infestations), Vaginal Infection (System Organ Class: Infections and Infestations), Bacterial Vaginosis
Frequency: 1 affected / 27 at risk

Adverse event: Upper Respiratory Disorders (General)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim: Allergic Rhinitis, Nasal Congestion, Sinus Disorder/Common Cold, Sinus Congestion, Rhinorrhea, Seasonal Allergies (sinus). Sinusitis, Respiratory Infection and Upper Respiratory Infection (System Organ Class: Infections and Infestations)
Frequency: 8 affected / 27 at risk

Adverse event: Lower Respiratory Disorders (General, not otherwise specified)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)
Frequency: 1 affected / 27 at risk

Adverse event: Ear Disorders (General)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)
Frequency: 2 affected / 27 at risk

Adverse event: Skin Infections (General)
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site
Frequency: 3 affected / 27 at risk

Adverse event: Infections (General), not otherwise specified
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal Pain Disorders (not otherwise specified)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim: Generalized Muscle Weakness, Muscle Cramping, Muscle Spasms, Muscle Tension, Muscle Cramping - back, Muscle Weakness - lower limb, Pain - left deltoid muscle, Leg Cramps, Leg Pain, Bone Pain, Jaw Clicking, Osteonecrosis-Jaw, Neck Tightness
Frequency: 7 affected / 27 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Verbatim Terms: Sinus Tachycardia, Rapid Heartbeat
Frequency: 2 affected / 27 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 27 at risk

Adverse event: White Blood Cells Decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 27 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 27 at risk