TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02482870

Adverse event: Cuts on lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minor cuts on lips occurring due to manipulations and pressure of the laryngoscope, mostly the blade.
Frequency: 3 affected / 202 at risk

Adverse event: Cuts on lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minor cuts on lips occurring due to manipulations and pressure of the laryngoscope, mostly the blade.
Frequency: 3 affected / 186 at risk
Study: NCT02482935

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk
Study: NCT02483000

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Mucositis, Oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT02483468

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation as a result of wearing actigraphy wrist device
Frequency: 1 affected / 65 at risk

Adverse event: Car accident
Serious: no
Organ System: Social circumstances
Notes: car accident unrelated to study procedures.
Frequency: 1 affected / 65 at risk
Study: NCT02483520

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Deemed by the IRB not related to the study
Frequency: 1 affected / 97 at risk
Study: NCT02483676

Adverse event: Pre-existing Medical Condition
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee pain
Frequency: 2 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Leg soreness, foot swelling
Frequency: 2 affected / 23 at risk

Adverse event: Asthenia
Serious: no
Organ System: Cardiac disorders
Notes: Dizziness, weakness
Frequency: 2 affected / 22 at risk
Study: NCT02483975

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 55 at risk
Study: NCT02484222

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 13 affected / 77 at risk
Study: NCT02484651

Adverse event: Neck pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Neck pain after discharge
Frequency: 1 affected / 35 at risk

Adverse event: Nausea and urinary retention
Serious: no
Organ System: General disorders
Notes: Nausea and urinary retention in the recovery
Frequency: 1 affected / 35 at risk

Adverse event: Emergence delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia of 120bpm in the recovery
Frequency: 1 affected / 35 at risk

Adverse event: Post-operative hypertension
Serious: no
Organ System: General disorders
Notes: Post-operative hypertension in the recovery room (Systolic Pressure 220 mmHg)
Frequency: 1 affected / 35 at risk

Adverse event: Asystole of 20 seconds
Serious: no
Organ System: Cardiac disorders
Notes: Asystole of 20 seconds during laryngoscopy resolved with IV atropine
Frequency: 1 affected / 35 at risk

Adverse event: Post-operative dyspnea and anxiety
Serious: no
Organ System: Surgical and medical procedures
Notes: Post-operative dyspnea and anxiety, shown on ENT examination, to have been caused by vocal cord paralysis due to a surgical complication
Frequency: 1 affected / 35 at risk
Study: NCT02484664

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach/abdominal pain
Frequency: 3 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: fatigue
Frequency: 3 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: malaise
Frequency: 2 affected / 12 at risk
Study: NCT02484859

Adverse event: Procedural hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Occurrence of intraoperative hypotension defined as a drop in mean blood pressure by \> 30% from baseline.
Frequency: 3 affected / 44 at risk

Adverse event: Intraoperative bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Occurrence of intraoperative bradycardia defined as heart rate below 50 beats per min.
Frequency: 18 affected / 44 at risk
Study: NCT02484898

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 182 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 182 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 182 at risk
Study: NCT02484911

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 56 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Oral ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk
Study: NCT02485158

Adverse event: vomiting from alcohol dose
Serious: no
Organ System: Gastrointestinal disorders
Notes: expected possible side effect of alcohol
Frequency: 1 affected / 28 at risk
Study: NCT02485353

Adverse event: Infections and infestations - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT02485418

Adverse event: emesis, abdominal pain & fever
Serious: yes
Organ System: Gastrointestinal disorders
Notes: patient with emesis, abdominal pain and fever at 24 hour follow-up. Patient seen in the ED 1 week prior to infusion with similar symptoms.
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients with nausea with peripheral intravenous line insertion, prior to infusion.
Frequency: 2 affected / 38 at risk
Study: NCT02485639

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild nausea reported by participant. Onset and end date of mild nausea was 2/17/2016. Deemed not related to study. Participant recovered completely. Not a Serious Adverse Event. No action taken.
Frequency: 1 affected / 27 at risk
Study: NCT02485704

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 145 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 145 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Redness
Frequency: 1 affected / 135 at risk
Study: NCT02485834

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

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

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT02485860

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 50 at risk

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

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 14 affected / 50 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 50 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 50 at risk

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

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

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk
Study: NCT02485912

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 20 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: feverish/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 20 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT02486016

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 10 at risk

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

Adverse event: Increased respiratory rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 10 at risk

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

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

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

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 10 at risk

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

Adverse event: Increased respiratory rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 10 at risk

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

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 10 at risk

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

Adverse event: Increased respiratory rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 10 at risk

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

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT02486042

Adverse event: Omegaven infusion rate discrepancy
Serious: no
Organ System: Surgical and medical procedures
Notes: 11/6/2016: HAL (hyperalimentation and intralipids) and Omegaven drips were hung but infusion rates were interchanged. Both drips were stopped and IV fluids without lipids were hung per physician orders.
Frequency: 1 affected / 21 at risk

Adverse event: Necrotising colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Infant had NEC for which exploratory laparotomy and ileostomy were created. Reported because infant was receiving omegaven as part of the study but is not outside the complications of premature birth.
Frequency: 1 affected / 21 at risk
Study: NCT02486211

Adverse event: Tongue swelling
Serious: no
Organ System: Gastrointestinal disorders
Notes: Tongue swelling secondary to tongue bite.
Frequency: 1 affected / 7 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: seizure
Frequency: 2 affected / 7 at risk
Study: NCT02486367

Adverse event: Major (TIMI3a or above) bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Permanent pacemaker placement
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 30 at risk

Adverse event: Major (TIMI3a or above) bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Permanent pacemaker placement
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk
Study: NCT02486627

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 303 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk
Study: NCT02487082

Adverse event: difficulty falling asleep
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: difficulty falling asleep
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk