TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00654069

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 136 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 136 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 135 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 135 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 135 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 135 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 135 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 135 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 135 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 134 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 134 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 134 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 134 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 134 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 134 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 134 at risk
Study: NCT00654147

Adverse event: Total bilirubin
Serious: yes
Organ System: Hepatobiliary disorders
Notes: grade 3 or greater elevation in total bilirubin
Frequency: 2 affected / 21 at risk

Adverse event: trigylcerides
Serious: yes
Organ System: Endocrine disorders
Notes: grade 3 or greater elevation in fasting blood triglycerides
Frequency: 2 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk
Study: NCT00654238

Adverse event: Deep Vein Thhrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Two patients had DVT Grade 3
Frequency: 2 affected / 55 at risk

Adverse event: Cerebral Vascular Accident/Stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebral Vascular Accident and or Stroke
Frequency: 2 affected / 55 at risk

Adverse event: Hand Foot Skin Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All Grades
Frequency: 43 affected / 55 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All Grades
Frequency: 41 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All Grades
Frequency: 29 affected / 55 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All Grades
Frequency: 25 affected / 55 at risk

Adverse event: Stomatitis/Mucositis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All Grades
Frequency: 18 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: All Grades
Frequency: 15 affected / 55 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All Grades
Frequency: 11 affected / 55 at risk

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: All Grades
Frequency: 9 affected / 55 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: All Grades
Frequency: 8 affected / 55 at risk

Adverse event: Squamous Cell Carcinoma of the Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All Grades
Frequency: 8 affected / 55 at risk

Adverse event: Anorexia and Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All Grades
Frequency: 7 affected / 55 at risk

Adverse event: Hepatic Lab Abnormalities
Serious: no
Organ System: Gastrointestinal disorders
Notes: All Grades
Frequency: 1 affected / 55 at risk
Study: NCT00654329

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate dropped to 42 bpm for 2 min post-op.
Frequency: 1 affected / 1 at risk
Study: NCT00654355

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT00654498

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 202 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 202 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 202 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 202 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 202 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 103 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 103 at risk
Study: NCT00654615

Adverse event: Anticipated
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Change in treatment due to observations during surgery
Frequency: 1 affected / 30 at risk

Adverse event: Anticipated
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Loss of fracture reduction
Frequency: 2 affected / 30 at risk

Adverse event: Anticipated
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Stiffness requiring removal of hardware
Frequency: 1 affected / 30 at risk

Adverse event: Unanticipated
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Sustained a median nerve contusion from initial injury and required carpal tunnel release three months after fracture fixation
Frequency: 1 affected / 30 at risk
Study: NCT00654628

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 173 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 173 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 173 at risk

Adverse event: Increased Creatine Phosphokinase (CPK)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 173 at risk

Adverse event: Increased Serum Glutamic Pyruvic Transaminase (SGPT)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 173 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 173 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 173 at risk
Study: NCT00654641

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any wound complication including superficial or deep surgical site infection, wound disruption, hematoma or seroma.
Frequency: 15 affected / 28 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any wound complication including superficial or deep surgical site infection, wound disruption, hematoma or seroma.
Frequency: 10 affected / 26 at risk
Study: NCT00654654

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE occurred prior to study treatment
Frequency: 1 affected / 50 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Notes: SAE occurred prior to study treatment
Frequency: 1 affected / 50 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE occurred after study treatment, and was considered unrelated by the Investigator.
Frequency: 1 affected / 50 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Nasophayngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk
Study: NCT00654732

Adverse event: Neutropennia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 26 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Infection
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Neutropennia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 32 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Infection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Respiratory Complicaton
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk
Study: NCT00654784

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 13 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 8 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT00654836

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: All patients died due to natural disease progression.
Frequency: 24 affected / 32 at risk

Adverse event: Abnormal hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 32 at risk

Adverse event: Abnormal Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hemorrhage of the Nose
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Proteinuria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Thrombosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Abnormal Liver Test (AST)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 32 at risk
Study: NCT00654875

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 164 at risk
Study: NCT00655083

Adverse event: hard stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, possibly treatment related, 2 hours post dosing and lasting up to the following day
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 12 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, possibly tretment related, 2 days after dosing lasting \< 1 day
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 8 at risk

Adverse event: dermatitis by diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild, unlikely treatment related
Frequency: 1 affected / 8 at risk
Study: NCT00655499

Adverse event: Occular hemorraghe
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 65 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Skin toxicity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 3/4
Frequency: 21 affected / 65 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3/4
Frequency: 8 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3/4
Frequency: 10 affected / 65 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3/4
Frequency: 1 affected / 65 at risk
Study: NCT00655564

Adverse event: Low CD4 cell count
Serious: yes
Organ System: Immune system disorders
Notes: CD4 cell count \<250 cells/uL
Frequency: 1 affected / 15 at risk

Adverse event: Severe allergic contact dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT00655642

Adverse event: Increased Sedation following treatment
Serious: no
Organ System: General disorders
Notes: Patients were asked whether they felt more fatigued or tired.
Frequency: 3 affected / 41 at risk

Adverse event: Pain at iv site following medication administration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients were asked if they experienced burning at the site of their intravenous catheter following drug administration.
Frequency: 6 affected / 41 at risk

Adverse event: Headache following treatment
Serious: no
Organ System: Nervous system disorders
Notes: Patients were asked if they experienced a new headache following drug administration?
Frequency: 2 affected / 41 at risk

Adverse event: Increased Sedation following treatment
Serious: no
Organ System: General disorders
Notes: Patients were asked whether they felt more fatigued or tired.
Frequency: 12 affected / 40 at risk

Adverse event: Pain at iv site following medication administration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients were asked if they experienced burning at the site of their intravenous catheter following drug administration.
Frequency: 3 affected / 40 at risk

Adverse event: Headache following treatment
Serious: no
Organ System: Nervous system disorders
Notes: Patients were asked if they experienced a new headache following drug administration?
Frequency: 2 affected / 40 at risk

Adverse event: Akathisia
Serious: no
Organ System: General disorders
Notes: Patient was asked if they are feeling abnormally restless or fidgety following drug administration?
Frequency: 7 affected / 40 at risk

Adverse event: Increased Sedation following treatment
Serious: no
Organ System: General disorders
Notes: Patients were asked whether they felt more fatigued or tired.
Frequency: 11 affected / 43 at risk

Adverse event: Pain at iv site following medication administration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients were asked if they experienced burning at the site of their intravenous catheter following drug administration.
Frequency: 6 affected / 43 at risk

Adverse event: Headache following treatment
Serious: no
Organ System: Nervous system disorders
Notes: Patients were asked if they experienced a new headache following drug administration?
Frequency: 1 affected / 43 at risk

Adverse event: Increased Sedation following treatment
Serious: no
Organ System: General disorders
Notes: Patients were asked whether they felt more fatigued or tired.
Frequency: 6 affected / 39 at risk

Adverse event: Pain at iv site following medication administration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients were asked if they experienced burning at the site of their intravenous catheter following drug administration.
Frequency: 1 affected / 39 at risk

Adverse event: Headache following treatment
Serious: no
Organ System: Nervous system disorders
Notes: Patients were asked if they experienced a new headache following drug administration?
Frequency: 4 affected / 39 at risk
Study: NCT00655707

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urinary tract infection requiring hospitalisation and antibiotic administration.
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: Mild fever following stem cell injection
Frequency: 4 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Mild abdominal pain reported following the stem cell injection
Frequency: 4 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea following stem cell injection
Frequency: 5 affected / 5 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Notes: Mild jaundice occurred following the stem cell injection
Frequency: 1 affected / 5 at risk

Adverse event: Ascites
Serious: no
Organ System: Hepatobiliary disorders
Notes: Mild ascvited developed following stem cell injection
Frequency: 3 affected / 5 at risk