Study: NCT03506815

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant with metastatic esophageal cancer (liver, bone, brain and lymph node metastases) had a Gastrointestinal Bleed leading to hospital admission and transfusion of 3 units of red blood cells.
Frequency: 1 affected / 52 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Febrile Neutropenia
Frequency: 1 affected / 1 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Notes: Fever
Frequency: 3 affected / 52 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Small bowel obstruction
Frequency: 3 affected / 52 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 52 at risk

Adverse event: Decreased O2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Decreased O2 saturation, req. O2, Query PE
Frequency: 1 affected / 52 at risk

Adverse event: Pnemonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Fungal Pnemonia- Rivaroxaban arm Pnemonia- Standard of Care Recurrent Pnemonia- Standard of care
Frequency: 1 affected / 52 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia

1 case asymptomatic anemia
Frequency: 1 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Common Cold
Frequency: 1 affected / 52 at risk

Adverse event: Chemotherapy Infusion Reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Chemotherapy infusion reaction
Frequency: 1 affected / 52 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Chest pain
Frequency: 1 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever
Frequency: 2 affected / 52 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Indigestion
Frequency: 2 affected / 52 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Lower back pain
Frequency: 1 affected / 52 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Migraine Headache
Frequency: 1 affected / 52 at risk

Adverse event: Radiation toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Radiation toxicity
Frequency: 1 affected / 52 at risk

Adverse event: Prolongation post chemo pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Prolongation post chemo pain
Frequency: 1 affected / 52 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: adhesive rash =2 bilateral lower leg=1
Frequency: 2 affected / 52 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 5 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 1 affected / 52 at risk

Adverse event: Urosepsis
Serious: no
Organ System: Infections and infestations
Notes: Urosepsis
Frequency: 1 affected / 52 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 53 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Chest Pain
Frequency: 1 affected / 53 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Diabetic Ulcer- Left foot
Frequency: 1 affected / 53 at risk

Adverse event: E-Coli, Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Notes: E-Coli, Urinary Tract Infection
Frequency: 1 affected / 53 at risk

Adverse event: Pnemonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Fungal Pnemonia- Rivaroxaban arm Pnemonia- Standard of Care Recurrent Pnemonia- Standard of care
Frequency: 2 affected / 53 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea \& vomiting
Frequency: 1 affected / 53 at risk

Adverse event: Neutropenia Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Neutropenia Enterocolitis
Frequency: 1 affected / 53 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal failure
Frequency: 1 affected / 53 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper Respitory Tract Infection
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia

1 case asymptomatic anemia
Frequency: 1 affected / 53 at risk

Adverse event: Chemotherapy Infusion Reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Chemotherapy infusion reaction
Frequency: 1 affected / 53 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Chest pain
Frequency: 1 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Dizziness
Frequency: 1 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 53 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD
Frequency: 1 affected / 53 at risk

Adverse event: Herpes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Herpes simplex vulva
Frequency: 1 affected / 53 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Notes: Hydronephrosis
Frequency: 1 affected / 53 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Intermittant yeast infections
Frequency: 1 affected / 53 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck pain
Frequency: 1 affected / 53 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Atrial Fibrillation
Frequency: 1 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: adhesive rash =2 bilateral lower leg=1
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Symptomatic Anemia
Frequency: 2 affected / 53 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: Syncopal Episode
Frequency: 1 affected / 53 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 2 affected / 53 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 1 affected / 53 at risk