TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01777321

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mallet finger
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arm movement
Serious: no
Organ System: General disorders
Frequency: 18 affected / 30 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 21 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 26 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 30 at risk

Adverse event: Fever/(Axillary)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 30 at risk

Adverse event: Myalgia (muscle aches)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Arm movement
Serious: no
Organ System: General disorders
Frequency: 12 affected / 30 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 30 at risk

Adverse event: Fever/(Axillary)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 30 at risk

Adverse event: Myalgia (muscle aches)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk
Study: NCT01777412

Adverse event: Hospitalization for Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Notes: 47 days after infusion of bevacizumab, patient developed a urinary tract infection that required hospitalization for 1 night and initiation of antibiotics. The infection was treated completely without complications.
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache during the infusion of bevacizumab was noted. The headache resolved with fluids.
Frequency: 1 affected / 10 at risk
Study: NCT01777568

Adverse event: SSI (organ space/deep)
Serious: yes
Organ System: Infections and infestations
Frequency: 112 affected / 2853 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 2853 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 143 affected / 2853 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 94 affected / 2853 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Infections and infestations
Frequency: 43 affected / 2853 at risk

Adverse event: uperficial SSI
Serious: no
Organ System: Infections and infestations
Frequency: 183 affected / 2853 at risk

Adverse event: SSI (organ space/deep)
Serious: yes
Organ System: Infections and infestations
Frequency: 118 affected / 2896 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Infections and infestations
Frequency: 34 affected / 2896 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 133 affected / 2896 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 96 affected / 2896 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Infections and infestations
Frequency: 43 affected / 2896 at risk

Adverse event: uperficial SSI
Serious: no
Organ System: Infections and infestations
Frequency: 150 affected / 2896 at risk
Study: NCT01777620

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 62 at risk
Study: NCT01777945

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Palmoplantar erythrodysesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 46 at risk
Study: NCT01778023

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 36 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 15 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Upper respiratory tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT01778062

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 68 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 68 at risk
Study: NCT01778127

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Cardiac disorders
Notes: Two children had abnormal ECG findings on their baseline cardiopulmonary fitness tests and were referred to their primary care physician. Neither was related to the study.
Frequency: 2 affected / 25 at risk
Study: NCT01778179

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Residual blisters from cryotherapy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Residual blisters from cryotherapy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk
Study: NCT01778530

Adverse event: Infusion related reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk
Study: NCT01778556

Adverse event: anemia secondary to menorrhagia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: abdominal pain of unknown etiology
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This adverse event was happened within 30 days window after the end of long-term follow-up.
Frequency: 1 affected / 15 at risk

Adverse event: angioedema secondary to angiotensin- converting enzyme inhibitor use
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: hypoglycemia (in a subject treated with insulin)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk
Study: NCT01778686

Adverse event: AE
Serious: no
Organ System: General disorders
Notes: Anaphylactic reaction
Frequency: 1 affected / 8 at risk
Study: NCT01778946

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk
Study: NCT01778985

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 15 at risk

Adverse event: Annoyance with cream use
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk
Study: NCT01779024

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 17 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 10 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 17 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 17 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 17 at risk
Study: NCT01779167

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Intermittent Creatinine increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Fatigue (worsened)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Aphasia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT01779375

Adverse event: Mental health hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Suicide ideation
Frequency: 1 affected / 47 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 47 at risk

Adverse event: Adenotonsillectomy
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pnemonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 47 at risk

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 47 at risk

Adverse event: Polyuria or polydipsia
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 47 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Ewing's Sarcoma
Frequency: 1 affected / 44 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Low blood sugar
Serious: no
Organ System: Endocrine disorders
Notes: self monitored blood glucose \<70 mg/dl during 3 months of glargine treatment
Frequency: 16 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 44 at risk

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 44 at risk

Adverse event: Polyuria or polydipsia
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 44 at risk
Study: NCT01779648

Adverse event: operative wound oozing
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: wound pain aggravation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 27 at risk

Adverse event: operative wound oozing
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: wound pain aggravation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 27 at risk
Study: NCT01780389

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Spontaneously reported
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Spontaneously reported
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Spontaneously reported
Frequency: 1 affected / 5 at risk

Adverse event: Painful ejaculation
Serious: no
Organ System: Nervous system disorders
Notes: Spontaneously reported
Frequency: 1 affected / 5 at risk
Study: NCT01780454

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk
Study: NCT01780584

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Notes: One patient in placebo group and one patient in high dose group were died during 7 days after surgery, due to irreversible cardiac pump failure. One patient in low dose group was died due to sepsis and heart failure 34 days after surgery.
Frequency: 1 affected / 15 at risk

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Notes: One patient in placebo group and one patient in high dose group were died during 7 days after surgery, due to irreversible cardiac pump failure. One patient in low dose group was died due to sepsis and heart failure 34 days after surgery.
Frequency: 1 affected / 15 at risk

Adverse event: Symptoms of suspected hyperthyroidism
Serious: no
Organ System: Cardiac disorders
Notes: Symptoms suggested hyperthyroidism were observed within 7 days after surgery. One patient in low dose group had hypertension after surgery due to unrecognized coarctation of the aorta.
Frequency: 1 affected / 15 at risk

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Notes: One patient in placebo group and one patient in high dose group were died during 7 days after surgery, due to irreversible cardiac pump failure. One patient in low dose group was died due to sepsis and heart failure 34 days after surgery.
Frequency: 1 affected / 15 at risk
Study: NCT01781026

Adverse event: Nausea/Vomiting/Weakness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk