Study: NCT02954055

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 63 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 6 affected / 63 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 8 affected / 63 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 41 affected / 63 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 21 affected / 63 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 63 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 6 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 12 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 13 affected / 63 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 7 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 17 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 9 affected / 63 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 30 affected / 63 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 20 affected / 63 at risk

Adverse event: Arthralgia and/or myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 22 affected / 63 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 36 affected / 63 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 3 affected / 63 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 63 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 63 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 13 affected / 63 at risk

Adverse event: Asparate aminotransferase increased
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 19 affected / 63 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hip fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 63 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 63 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 70 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 4 affected / 70 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 70 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 70 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 70 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 1 affected / 70 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 4 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 20 affected / 70 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 3 affected / 70 at risk

Adverse event: Pulmonary valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 70 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 70 at risk

Adverse event: Nail discolouration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 26 affected / 70 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 70 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 70 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 22 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 6 affected / 70 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 30 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 8 affected / 70 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 5 affected / 70 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 14 affected / 70 at risk

Adverse event: Arthralgia and/or myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 20 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 31 affected / 70 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 4 affected / 70 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 2 affected / 70 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 10 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 11 affected / 70 at risk

Adverse event: Asparate aminotransferase increased
Serious: no
Organ System: Immune system disorders
Notes: Adverse events were collected from the first dose of trial medication until 28 days after all treatment discontinuation (end of treatment visit), regardless of whether it is considered related to a medication.
Frequency: 14 affected / 70 at risk

Adverse event: Aortic valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Sudden death, not otherwise specified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 70 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Facial nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk