Study: NCT03344861

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: On Study Day 4, subject received 2 doses of Toradol and on that same day complained of stomachache. On Study Days 4 \& 5 subject had diarrhea. On Study Day 5 subject was diagnosed with moderate gastrointestinal bleed (CTCAE Grade 2).
Frequency: 1 affected / 10 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced hemorrhagic shock (CTCAE Grade 4).
Frequency: 1 affected / 10 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced pleural effusion (recurrent right pleural effusion CTCAE Grade 2).
Frequency: 1 affected / 10 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced acute hypoxemic respiratory failure CTCAE Grade 4.
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced anemia CTCAE Grade 3.
Frequency: 1 affected / 10 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced iatrogenic right haemothorax CTCAE Grade 3 diagnosed from CT angiogram.
Frequency: 1 affected / 10 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced atrial fibrillation with rapid ventricular response CTCAE Grade 2 that converted to sinus.
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject hospitalized for scheduled right colectomy for colon cancer and experienced dyspnoea CTCAE Grade 2.
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Subject hospitalized with symptoms of cough, fever and chills resulting from sepsis CTCAE Grade 1.
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalized with pneumonia aspiration CTCAE Grade 2 along with sepsis.
Frequency: 1 affected / 10 at risk

Adverse event: Gastro-oesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: While hospitalized for sepsis and pneumonia aspiration, subject experience CTCAE Grade 2 SAE (Serious Adverse Event) of gastrooesophageal reflux disease
Frequency: 1 affected / 10 at risk

Adverse event: Deep Vein Thrombosis (DVT) Right
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalized with CTCAE Grade 3 deep vein thrombosis right.
Frequency: 1 affected / 10 at risk

Adverse event: Deep Vein Thrombosis Left
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: While hospitalized with DVT Right, subject experienced a CTCAE Grade 2 SAE of deep vein thrombosis left.
Frequency: 1 affected / 10 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Face swelling due to photosensitivity reaction.
Frequency: 1 affected / 10 at risk

Adverse event: Facial Blisters
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Blisters on face due to photosensitivity to drug.
Frequency: 1 affected / 10 at risk

Adverse event: Forearm Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin erythema on both forearms
Frequency: 2 affected / 10 at risk

Adverse event: Hand Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild hand erythema from photosensitivity to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Facial erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermal erythema (sunburn) on face due to photosensitivity to study drug
Frequency: 2 affected / 10 at risk

Adverse event: Erythema on calves
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermal erythema (sunburn) on calves due to photosensitivity to study drug
Frequency: 1 affected / 10 at risk

Adverse event: Abdomen erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Abdomen redness due to photosensitivity to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Congenital diaphragmatic hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Blood alkaline phosphatase decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatinine decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood urea abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Chest X-ray abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: False negative investigation result
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Haematocrit increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Prothrombin time abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Red blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: X-ray abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Protein deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Adenocarcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Lung neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 10 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Respiratory abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thoracic operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: Prothrombin time shortened
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk