TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01929226

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 210 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 210 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 210 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 210 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 210 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 210 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 210 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: A 42-year old, White female was hospitalized on study Day 101 and underwent surgery for removal of both ovaries and appendix. The investigator reported an unrelated serious AE of ovarian cyst of moderate severity that resolved after one day.
Frequency: 1 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 70 at risk
Study: NCT01929395

Adverse event: Haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 1 affected / 69 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 1 affected / 69 at risk
Study: NCT01929460

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: one patient in the placebo arm was admitted for post-procedure pancreatitis. Recovered without incident.
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 cases deemed unrelated to the procedure (1, nephrolithiasis; 1, chronic abdominal pain).

1 case deemed probably unrelated

1 case deemed possibly related but resolved uneventfully with conservative measures only
Frequency: 4 affected / 13 at risk
Study: NCT01929642

Adverse event: Aphthous ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT01929681

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: A night of insomnia reported the night after the second of three treatments
Frequency: 1 affected / 26 at risk
Study: NCT01929707

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk
Study: NCT01929863

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk
Study: NCT01929876

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT01929889

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Emergent suicidal ideation (n.b., no suicide attempt was made). The subject was admitted to hospital.
Frequency: 3 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk
Study: NCT01929980

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

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: C diff colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cellulitis at subcutaneous injection site
Frequency: 1 affected / 4 at risk
Study: NCT01929993

Adverse event: Hysterectomy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hysterectomy due to vascular injury
Frequency: 1 affected / 81 at risk

Adverse event: Needed general anesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Needed general anesthesia due to some discomfort during the procedure.
Frequency: 1 affected / 81 at risk

Adverse event: Vulvovaginal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Accidental opening of the vaginal mucosa up to near the muscle layer of the bladder.
Frequency: 1 affected / 78 at risk

Adverse event: Needed general anesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Needed general anesthesia due to some discomfort during the procedure.
Frequency: 1 affected / 78 at risk
Study: NCT01930045

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk
Study: NCT01930058

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk
Study: NCT01930123

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk
Study: NCT01930747

Adverse event: post operative bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: post operative hypertension and bleeding requiring admission on intensive care followed by laparoscopic revision for bleeding.

patient recovered without any remaining lesions.
Frequency: 1 affected / 12 at risk
Study: NCT01931033

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

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

Adverse event: Mental fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Lump in Throat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tightness in Fingers
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01931150

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT01931163

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Papilloedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 22 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk
Study: NCT01931202

Adverse event: Fall
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT01931735

Adverse event: Car accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Wrist reconstructed due to a car accident injury. Injury is unrelated to the study.
Frequency: 1 affected / 11 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Endocrine disorders
Notes: Diabetic ulcer resulted in toe amputation. This adverse event is unrelated to the study.
Frequency: 1 affected / 11 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Immune system disorders
Notes: Unrelated to the study.
Frequency: 1 affected / 11 at risk
Study: NCT01932112

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 378 at risk
Study: NCT01932294

Adverse event: Rehospitalization
Serious: yes
Organ System: Investigations
Notes: All-cause Rehospitalizations
Frequency: 93 affected / 171 at risk

Adverse event: IV Inotropes Dependent at 6 months
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 171 at risk

Adverse event: All-location Infection
Serious: no
Organ System: Infections and infestations
Notes: All-location Infection
Frequency: 12 affected / 171 at risk
Study: NCT01932437

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ectopic pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 9 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Lip blister
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT01932788

Adverse event: Preterm birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 135 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 135 at risk

Adverse event: Preterm birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 118 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 118 at risk
Study: NCT01932970

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 148 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 148 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 148 at risk

Adverse event: Arteriovenous graft site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Biliary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 148 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 148 at risk

Adverse event: Procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 148 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 148 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 148 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 148 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 148 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 148 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 148 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 148 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk
Study: NCT01933048

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalized overnight for hematoma after lipoma excision. Not related to procedure. Relatedness=unrelated.
Frequency: 1 affected / 548 at risk

Adverse event: Hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization; chest/abdominal wall herniation from previous injury. Not related to procedure. Relatedness=unrelated.
Frequency: 1 affected / 548 at risk

Adverse event: Nasal and chest congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 548 at risk

Adverse event: Sinusitus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Cough and sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 548 at risk

Adverse event: Tiredness and weakness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 548 at risk

Adverse event: Nausea and diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 548 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalized 4 days for pulmonary embolism. Not related to procedure. Relatedness=not probable.
Frequency: 1 affected / 529 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalized 4 days for deep vein thrombosis. Not related to procedure. Relatedness=not probable.
Frequency: 1 affected / 529 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related to procedure. Relatedness=unrelated
Frequency: 1 affected / 529 at risk

Adverse event: Syncope
Serious: no
Organ System: Surgical and medical procedures
Notes: Related to blood draw. Relatedness=definitely.
Frequency: 2 affected / 529 at risk

Adverse event: Nasal and chest congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 529 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 529 at risk

Adverse event: Cough and sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 529 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 529 at risk

Adverse event: Tiredness and weakness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 529 at risk

Adverse event: Nausea and diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 529 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 529 at risk