Study: NCT03214666

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Count: 10 (6 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 1 Grade 2 Count: 1 Unrelated to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Count: 2 Grade 1 Count: 1 Unrelated/unlikely related to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: IL-6 Increase
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 2 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Notes: Grade 1 Count: 2 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 2 (2 Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 4 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 2 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 3 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 2 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 9 (8 possibly and 1 probably related to GTB-3550) Grade 2 Count: 3 (3 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Gingival bleeding/blood blister
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 5 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: LDH elevated - intermittent
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Ferritin elevation
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: CRP elevation
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 3 (1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fibrinogen elevation
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Chloride increase - intermittent
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 2 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 3 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Restlesness
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: All Grade 3; 2 possibly related to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3; Unrelated to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: LDH Increase
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: C-reactive protein increase
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 Count: 1 (Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Count: 10 (6 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 1 Grade 2 Count: 1 Unrelated to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 5 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: IL-6 increase
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: CRP elevation
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 3 (1 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Chloride increase - intermittent
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 4 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 2 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Rash - L leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 9 (8 possibly and 1 probably related to GTB-3550) Grade 2 Count: 3 (3 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Count: 10 (6 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3; Unlikely related to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Count: 10 (6 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 2 (2 Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 2 Count: 3 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: All Grade 3; 2 possibly related to GTB-3550
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Count: 10 (6 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 Count: 2 Grade 1 Count: 1 Unrelated/unlikely related to GTB-3550
Frequency: 2 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Notes: Grade 1 Count: 2 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1 Count: Mild (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 5 (1 possibly and 1 probably related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 2 (2 Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 4 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 4 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 2 Count: 3 (1 possibly and 1 probably related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 Count: 1 (Possibly related to GTB-3550) Grade 2 Count: 2 (1 Possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Muscle spasms, intermittent
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 1 (Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 Count: 1 (Unlikely related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: On oxygen with no documented hypoxia, intermittent
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 Count: 1 (Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 1 (Possibly related to GTB-3550)
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)
Frequency: 2 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 Count: 9 (8 possibly and 1 probably related to GTB-3550) Grade 2 Count: 3 (3 possibly related to GTB-3550)
Frequency: 2 affected / 2 at risk