TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03138603

Adverse event: Hypotension event
Serious: no
Organ System: Cardiac disorders
Notes: A recorded period when systolic blood pressure reading was lower than 90 mm Hg.
Frequency: 8 affected / 34 at risk

Adverse event: Bradycardia Event
Serious: no
Organ System: Cardiac disorders
Notes: A recorded period when heart rate was below 60-beats per minute.
Frequency: 1 affected / 38 at risk

Adverse event: Hypotension event
Serious: no
Organ System: Cardiac disorders
Notes: A recorded period when systolic blood pressure reading was lower than 90 mm Hg.
Frequency: 2 affected / 38 at risk
Study: NCT03138967

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Laceration of penis' skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hematuria with Clot retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hematuria with Clot retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: IV infiltration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk
Study: NCT03139240

Adverse event: Ongoing pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Resolved with standard treatment measures.
Frequency: 4 affected / 86 at risk

Adverse event: Ongoing pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Resolved with standard treatment measures.
Frequency: 2 affected / 86 at risk
Study: NCT03139318

Adverse event: Surgical wound breakdown (Grade 2)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Surgical wound breakdown (Grade 3)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk
Study: NCT03139435

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk
Study: NCT03140423

Adverse event: Other (Not Including Serious) Adverse Event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 185022 at risk
Study: NCT03140631

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Minor vascular complication
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 73 at risk

Adverse event: Major vascular complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Minor vascular complication
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 77 at risk
Study: NCT03140670

Adverse event: Hepatic dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Included Grade 2 elevated bilirubin
Frequency: 1 affected / 42 at risk
Study: NCT03141086

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

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

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT03141242

Adverse event: Psychological Distress
Serious: no
Organ System: Psychiatric disorders
Notes: Emotional triggering due to content of advance care planning and/or group visit discussion
Frequency: 1 affected / 55 at risk
Study: NCT03141255

Adverse event: Bradycardic Arrest
Serious: yes
Organ System: General disorders
Notes: Patient underwent bradycardia with subsequent PEA arrest during rewarming after cooling. This was classified as a serious adverse event which was deemed to be possibly related to the trial by the Data Safety Monitoring Board (DSMB)
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 2 patients had mild bleeding with 2-4u transfusion requirements during hospitalization. Both events were deemed as possibly related to trial.
Frequency: 2 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Bradycardia during cooling, improved with discontinuation of amiodarone
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Worsening hyperglycemia during cooling in a patient with a history of DM2. Deemed as possibly related to trial.
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Patient had hypotension during cooling requiring pressors.
Frequency: 1 affected / 10 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Patient had NSVT after trial enrollment deemed possibly related to the trial
Frequency: 1 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Shivering related to cooling that was treated with warming blankets and sedation, cessation of cooling was not required
Frequency: 2 affected / 10 at risk

Adverse event: Aspiration Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient had aspiration during cooling with subsequent concern for sepsis without positive blood cultures. This was classified as a possibly related adverse event
Frequency: 1 affected / 10 at risk
Study: NCT03141788

Adverse event: Bleeding Gums
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bleeding Gums
Frequency: 1 affected / 52 at risk

Adverse event: Filling Fell Off Tooth
Serious: no
Organ System: Product Issues
Notes: Filling Fell Out of Tooth
Frequency: 1 affected / 52 at risk
Study: NCT03141905

Adverse event: Initiation of Hemodialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lab Alert: Glucose ≥ 499 mg/dL
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lab Alert: Potassium ≥ 6.1 mEq/dL
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Lab Alert: Hemoglobin ≤ 7.5 g/dL
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lab Alert: Chloride ≥ 115 mEq/dL
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 159 at risk

Adverse event: Lab Alert: Co2 ≤ 15 mEq/L
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Initiation of Hemodialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 156 at risk

Adverse event: Lab Alert: Glucose ≥ 499 mg/dL
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 156 at risk

Adverse event: Lab Alert: Potassium ≥ 6.1 mEq/dL
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 156 at risk
Study: NCT03141931

Adverse event: Digestive issues
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 61 at risk

Adverse event: Digestive issues
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 58 at risk
Study: NCT03142451

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 494 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 494 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 494 at risk

Adverse event: Seasonal allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 494 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 494 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 494 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 494 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 494 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 256 at risk
Study: NCT03142750

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Child developed small pinpoint rash under the dressing. It was noted after dressing was removed.
Frequency: 1 affected / 14 at risk
Study: NCT03143218

Adverse event: Non-fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 65 affected / 1965 at risk

Adverse event: Fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1965 at risk

Adverse event: Non-fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 67 affected / 1988 at risk

Adverse event: Fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 1988 at risk

Adverse event: Non-fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 56 affected / 1967 at risk

Adverse event: Fatal SAEs
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1967 at risk
Study: NCT03143257

Adverse event: Implant site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Incision site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Medical device site discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 71 at risk

Adverse event: Skin hypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk
Study: NCT03143569

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Thrombotic events
Frequency: 2 affected / 10 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Thrombotic events
Frequency: 3 affected / 10 at risk
Study: NCT03143816

Adverse event: mild cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 patients reported mild cough in TI group but they continued in the trial.
Frequency: 3 affected / 26 at risk
Study: NCT03143855

Adverse event: Vomiting
Serious: no
Organ System: Psychiatric disorders
Notes: Participant experienced withdrawal symptoms and receive Zofran. We felt it was not related to the study drug but was related to the participant taking more opioids than he told us which led to his withdrawal symptoms.
Frequency: 1 affected / 6 at risk
Study: NCT03144232

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 37 at risk

Adverse event: Eye twitch
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Site discomfort
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hand numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk
Study: NCT03144635

Adverse event: Serious ALT elevation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: ALT\>300 U/L during treatment
Frequency: 3 affected / 80 at risk
Study: NCT03145259

Adverse event: Menstrual flow
Serious: no
Organ System: General disorders
Notes: light menstrual flow (participant noted different from normal)
Frequency: 1 affected / 12 at risk

Adverse event: decreased blood pressure
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 12 at risk

Adverse event: increased heart rate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: post blood draws
Frequency: 1 affected / 12 at risk

Adverse event: skin erythema (redness)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: decreased blood pressure
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 12 at risk

Adverse event: increased heart rate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: skin dryness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: skin itching
Serious: no
Organ System: General disorders
Frequency: 6 affected / 12 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: skin tingly sensation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: upset stomach/indigestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: skin erythema (redness)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 12 at risk

Adverse event: decreased blood pressure
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 12 at risk

Adverse event: raised skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 12 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: General disorders
Notes: from tape strips used for skin tape stripping
Frequency: 1 affected / 12 at risk

Adverse event: scabs
Serious: no
Organ System: General disorders
Notes: skin tape stripping sites
Frequency: 2 affected / 12 at risk

Adverse event: skin itching
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: skin erythema (redness)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk
Study: NCT03145480

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

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

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 3 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 3 affected / 3 at risk

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Alkaline phosphatase elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT03146403

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

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

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

Adverse event: Disturbance in attention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 16 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 16 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 16 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: ≥100.4°F
Frequency: 3 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 16 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

Adverse event: Nausea
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: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk
Study: NCT03146741

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Post-op re-intubation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cytomegalovirus test
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Terminal ileun ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Non-infective gastroenteritis and colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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