Study: NCT04972630

Adverse event: Dyselectrolytemia and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drowsiness and disorientation with vomiting.
Frequency: 1 affected / 43 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Epigastric pain, petechial lesion in the right forearm.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: General disorders
Notes: Abdominal distention, Shortness of breath, seizures, senselessness, fever and coffee colored stool.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of disease and Dyselectrolytemia
Serious: yes
Organ System: General disorders
Notes: Abdominal discomfort and pain, decreased urine output and irrelevant talks
Frequency: 1 affected / 43 at risk

Adverse event: Disorientation and Reduced intake of Food
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Bleeding from lower lip, disorientation on and off, reduced intake of food, generalized weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: General disorders
Notes: Breathlessness on exertion, Anasarca
Frequency: 1 affected / 43 at risk

Adverse event: Low hemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Bleeding per rectum and vagina.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Breathlessness intermittently, Bleeding PV, Recto-vaginal fistula, Feverish.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: General disorders
Notes: Unresponsive.
Frequency: 2 affected / 43 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Cardiac disorders
Notes: Shortness of breath, hypotension.
Frequency: 1 affected / 43 at risk

Adverse event: Deep Vein Thrombosis, Dyselectrolytemia, and Suspected Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Swelling of right upper limbs, generalized weakness and tremors ,deep vein thrombosis, Dyselectrolytemia and suspected sepsis
Frequency: 1 affected / 43 at risk

Adverse event: Progression Of Disease With Pneumonia
Serious: yes
Organ System: General disorders
Notes: Vomiting, Dizziness, Blurring of vision, Headache, Cough and Back pain.
Frequency: 1 affected / 43 at risk

Adverse event: Hypoproteinemia, Anemia and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Dysuria, scrotal swelling in genital area and whole body edema, hypotensive
Frequency: 1 affected / 43 at risk

Adverse event: Dyselectrolytemia and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Reduced appetite, unable to swallow, Imbalance in gait, Urinary incontinence, Drowsy, Loose stools.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drowsiness.
Frequency: 1 affected / 43 at risk

Adverse event: Infection and UTI
Serious: yes
Organ System: Infections and infestations
Notes: Fever and weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Upper GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hematemesis
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pain in abdomen \& vomiting.
Frequency: 1 affected / 43 at risk

Adverse event: Hypogastric plexus and Block
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pain in lower abdomen and left leg.
Frequency: 1 affected / 43 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: General disorders
Notes: Pain, cough, low grade fever.
Frequency: 1 affected / 43 at risk

Adverse event: PR Bleeding and Generalized weakness
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: PR Bleeding, Leading to anemia, Malena, Generalized weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath, Hemoptysis, Melena, Upper abdomen pain, Vomiting, jaundice
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Tumor site bleeding, Shortness of breath.
Frequency: 1 affected / 43 at risk

Adverse event: Patient Expired at Home
Serious: yes
Organ System: General disorders
Notes: Family informed that patient expired at home.
Frequency: 16 affected / 43 at risk

Adverse event: Patient Expired at Local Hospital
Serious: yes
Organ System: General disorders
Notes: Family informed that patient expired at local Hospital.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: General disorders
Notes: Patient came in emergency with c/o twitching of right side face, pain in right side chest, edema
Frequency: 1 affected / 43 at risk

Adverse event: Consumption of a liquid mosquito repellent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Consumption of a liquid mosquito repellent. Volume not specified. C/o mild SOB. No other complain.
Frequency: 1 affected / 43 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathlessness, cold, reduced intake of food.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathlessness, Urinary retention.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory distress.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath, chest pain, disorientation.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Constipation, nausea, abdominal distension and pain, vomiting.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Anorexia, not able to eat or drink, high colored urine, yellowish discoloration, generalized itching.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: General disorders
Notes: Both leg pedal edema, abdominal distension, generalized weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath.
Frequency: 1 affected / 43 at risk

Adverse event: Subacute intestinal obstruction.
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain, abdominal tightness, bloating, dyspepsia, anorexia, generalized weakness, vomiting (brownish color).
Frequency: 1 affected / 43 at risk

Adverse event: Subacute intestinal obstruction.
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain.
Frequency: 1 affected / 43 at risk

Adverse event: Infection and Dyselectrolytemia
Serious: yes
Organ System: General disorders
Notes: Abdominal distension, Weakness ,Vomiting.
Frequency: 1 affected / 43 at risk

Adverse event: Ulcer proliferative Lesion
Serious: yes
Organ System: General disorders
Notes: Bleeding and headache. On examination he was found to have a large ulcer proliferative lesion in his left cheek and angle of mouth. The lesion was bleeding and pus was draining which was foul-smelling.
Frequency: 1 affected / 43 at risk

Adverse event: Hypertension, Dehydrated, Cachectic, and Tense Ascites
Serious: yes
Organ System: General disorders
Notes: Drowsiness, generalized weakness and abdominal distension. Hypotension with a BP of 70/40mmHg and dehydrated and cachectic and also had tense ascites.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Dysphagia, anorexia, generalized weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis and Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Generalized weakness, loose stool, constipation, generalized body pain, appetite loss.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Generalized weakness, Insomnia and Anxiety.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Generalized weakness, Black stools
Frequency: 1 affected / 43 at risk

Adverse event: Fluctuating BP and blood sugar
Serious: yes
Organ System: General disorders
Notes: Generalized weakness, fluctuating BP and blood sugar, occasional bleeding from tumor site, dehydration.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis, Diabetic Ketoacidosis and Dyselectrolytemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Generalized weakness, decreased intake of food
Frequency: 1 affected / 43 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Constipation, anorexia and weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Dyselectrolytemia and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drowsiness and constipation, decreased intake of food.
Frequency: 1 affected / 43 at risk

Adverse event: Progression of Disease and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Drowsiness, No urine.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Vomiting, generalized weakness and abdominal pain.
Frequency: 1 affected / 43 at risk

Adverse event: Dyselectrolytemia and Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Shortness of breath, generalized weakness.
Frequency: 1 affected / 43 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Notes: Fever with rash.
Frequency: 1 affected / 43 at risk

Adverse event: Cerebral metastases
Serious: yes
Organ System: Nervous system disorders
Notes: Involuntary facial muscle twitching, restlessness, drowsiness, back pain, seizures.
Frequency: 1 affected / 43 at risk

Adverse event: Electrolyte disturbance.
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Mild facial deviation. Face deviated toward one side for 5 sec, and there was dribbling of water from angle of mouth.
Frequency: 1 affected / 43 at risk

Adverse event: ICD Block
Serious: yes
Organ System: Cardiac disorders
Notes: No output from ICD.
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis and Hypoglycemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory distress, slurring of speech.
Frequency: 1 affected / 43 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Severe respiratory distress, tachycardia, hyperglycemia.
Frequency: 1 affected / 43 at risk

Adverse event: severe anemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 43 at risk

Adverse event: Patient Expired at Home
Serious: yes
Organ System: General disorders
Notes: Family informed that patient expired at home.
Frequency: 14 affected / 43 at risk

Adverse event: Patient Expired at Local Hospital
Serious: yes
Organ System: General disorders
Notes: Family informed that patient expired at local Hospital.
Frequency: 4 affected / 43 at risk