Study: NCT01922921

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: 4/7 events reported were related to placebo arm 4/5 events reported were related to the treatment arm
Frequency: 6 affected / 16 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: 4/4 events reported were related to the placebo arm 1/3 events reported were related to the treatment arm
Frequency: 3 affected / 16 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 16 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: 1/1 events reported was related to placebo arm 1/1 events reported was related to the treatment arm
Frequency: 1 affected / 16 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Other - rhinorrhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1/4 events reported were related to placebo arm 1/6 events reported were related to treatment arm
Frequency: 4 affected / 16 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Other - pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1/1 events reported was related to placebo arm 6/9 events reported were related to the treatment arm
Frequency: 1 affected / 16 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/4 events reported were related to placebo arm 7/8 events reported were related to treatment arm
Frequency: 3 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3/5 events reported were related to placebo arm
Frequency: 3 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2/4 events reported were related to placebo arm
Frequency: 2 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/2 events reported were related to placebo arm
Frequency: 2 affected / 16 at risk

Adverse event: Other - minor acid reflux after drinking tea for half hour or so
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/3 events reported were related to placebo arm
Frequency: 2 affected / 16 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Other - acne/rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 2/2 events reported were related to the treatment arm
Frequency: 5 affected / 16 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: 5/8 events reported were related to placebo arm 12/12 events reported were related to treatment arm
Frequency: 7 affected / 16 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: 1/1 reported events was related to the treatment arm
Frequency: 1 affected / 16 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: 29/29 events reported were related to placebo arm 25/26 events reported were related to treatment arm
Frequency: 14 affected / 16 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: 1/1 events reported was related to placebo arm 1/2 events reported were related to treatment arm
Frequency: 1 affected / 16 at risk

Adverse event: Other - head sweats-daily
Serious: no
Organ System: Vascular disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1/1 reported events was related to treatment arm
Frequency: 5 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1/2 events reported were related to placebo arm
Frequency: 2 affected / 16 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 2/3 events reported were related to treatment arm
Frequency: 1 affected / 16 at risk

Adverse event: Other - dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Other - engorged breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Other - hyperactive-increase senstivity of allergens-food, pollen, bug bite
Serious: no
Organ System: Immune system disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 16 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: 4/7 events reported were related to placebo arm 4/5 events reported were related to the treatment arm
Frequency: 4 affected / 15 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: 4/4 events reported were related to the placebo arm 1/3 events reported were related to the treatment arm
Frequency: 3 affected / 15 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: 1/1 events reported was related to placebo arm 1/1 events reported was related to the treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 2 affected / 15 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1/1 events reported was related to placebo arm
Frequency: 1 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1/4 events reported were related to placebo arm 1/6 events reported were related to treatment arm
Frequency: 6 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1/1 events reported was related to placebo arm 6/9 events reported were related to the treatment arm
Frequency: 7 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/4 events reported were related to placebo arm 7/8 events reported were related to treatment arm
Frequency: 6 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 2/2 events reported were related to the treatment arm
Frequency: 2 affected / 15 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: 5/8 events reported were related to placebo arm 12/12 events reported were related to treatment arm
Frequency: 7 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: 1/1 reported events was related to the treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: 29/29 events reported were related to placebo arm 25/26 events reported were related to treatment arm
Frequency: 13 affected / 15 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: 1/1 events reported was related to placebo arm 1/2 events reported were related to treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1/1 reported events was related to treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 2/3 events reported were related to treatment arm
Frequency: 2 affected / 15 at risk

Adverse event: Blood bilirubin increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Post nasal drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Right knee pain increased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Left lip cold sores (Herpes)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hematochezia - 2 episodes
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3/3 events reported were related to the treatment arm
Frequency: 2 affected / 15 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1/1 events reported was related to the treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Umbilical follicitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Scalp skin nodule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infusion related reactions
Serious: no
Organ System: General disorders
Notes: 1/1 events reported was related to treatment arm
Frequency: 1 affected / 15 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1/2 events reported were related to the treatment arm
Frequency: 2 affected / 15 at risk

Adverse event: Cystitis - UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk