Study: NCT03474640

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 1 affected / 3 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 1 affected / 3 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Reproductive System and Breast Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 2 affected / 8 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 2 affected / 8 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 1 affected / 8 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 2 affected / 8 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 3 affected / 8 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 1 affected / 8 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 1 affected / 8 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 2 affected / 7 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 1 affected / 7 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 1 affected / 7 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 1 affected / 7 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 1 affected / 7 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 1 affected / 7 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Infusion related reaction
Frequency: 1 affected / 7 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: Myocarditis
Frequency: 1 affected / 7 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 1 affected / 7 at risk

Adverse event: Neoplasms benign, malignant, and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Tumor pain
Frequency: 1 affected / 7 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 59 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 59 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 59 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Skin and Subcutaneous Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Endocrine Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 59 at risk

Adverse event: Immune System Disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 9 affected / 59 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 12 affected / 59 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 10 affected / 59 at risk

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

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 10 affected / 59 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 5 affected / 59 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 10 affected / 59 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 1 affected / 59 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain, muscular weakness
Frequency: 3 affected / 59 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Infusion related reaction
Frequency: 1 affected / 59 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 3 affected / 59 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 2 affected / 3 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 1 affected / 3 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 3 affected / 11 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 3 affected / 11 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 2 affected / 11 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 3 affected / 11 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 2 affected / 11 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 1 affected / 11 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 6 affected / 29 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 4 affected / 29 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 4 affected / 29 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 4 affected / 29 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 4 affected / 29 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 2 affected / 29 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 1 affected / 29 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 5 affected / 29 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Infusion related reaction
Frequency: 1 affected / 29 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 42 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 42 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 42 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 2 affected / 42 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 12 affected / 42 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 11 affected / 42 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 4 affected / 42 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 11 affected / 42 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 6 affected / 42 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 1 affected / 42 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, peripheral neuropathy, dizziness, dysgeusia
Frequency: 1 affected / 42 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain, muscular weakness
Frequency: 4 affected / 42 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Metabolism and Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Skin and Subcutaneous Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Skin and Subcutaneous Disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus, dry skin
Frequency: 5 affected / 22 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: transaminases increased, lipases increased
Frequency: 3 affected / 22 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, chills, oedema
Frequency: 6 affected / 22 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 2 affected / 22 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain
Frequency: 4 affected / 22 at risk

Adverse event: Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia, anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Frequency: 1 affected / 22 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism, hypothyroidism
Frequency: 2 affected / 22 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain, muscular weakness
Frequency: 1 affected / 22 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Infusion related reaction
Frequency: 1 affected / 22 at risk