TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03780543

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: fatique
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 43 at risk

Adverse event: fatique
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: fatique
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk
Study: NCT03781479

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

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

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Intranasal paraesthesia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk
Study: NCT03781778

Adverse event: Gassiness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Increased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Increased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

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

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk
Study: NCT03781791

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 93 at risk

Adverse event: Abdominal Pail
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 93 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Abdominal Pail
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk
Study: NCT03781817

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting after the conclusion of the sedation and procedure not including nausea.
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting after the conclusion of the sedation and procedure not including nausea.
Frequency: 3 affected / 23 at risk
Study: NCT03782064

Adverse event: Rash, maculopapular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Alkaline Phosphatase Increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Muscle Weakness (lower limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain, hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT03782116

Adverse event: Transient muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT03782259

Adverse event: Non-ST-elevation myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: PI determined not related to study intervention with causality as pre-existing/underlying disease - ASCVD, Diabetes.
Frequency: 1 affected / 31 at risk
Study: NCT03782272

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT03782298

Adverse event: PAIN OVER LATERAL ASPECT OF LEFT ANKLE (ONGOING AT 6 MONTHS).
Serious: no
Organ System: General disorders
Notes: Unlikely related to device
Frequency: 1 affected / 17 at risk

Adverse event: PAIN OVER LATERAL ASPECT OF LEFT ANKLE AT 6 MONTHS
Serious: no
Organ System: General disorders
Notes: Possibly related to device
Frequency: 1 affected / 17 at risk

Adverse event: SUPERFICIAL YEAST INFECTION
Serious: no
Organ System: Infections and infestations
Notes: Unlikely related to device
Frequency: 1 affected / 17 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to device
Frequency: 1 affected / 17 at risk

Adverse event: FALL DOWN ON LEFT HEEL
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 17 at risk

Adverse event: HOSPITALIZATION FOR UTI, ACUTE RENAL FAILURE, SEPSIS
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 71 at risk

Adverse event: Complex regional pain syndrome
Serious: yes
Organ System: General disorders
Notes: Definitely related to device
Frequency: 1 affected / 71 at risk

Adverse event: SURAL NERVE DAMAGE AND MONONEUROPATHY/PAIN SYNDROME FROM POPLITEAL ANESTHETIC BLOCK.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: HOSPITALIZATION FOR UTI, ACUTE RENAL FAILURE, SEPSIS
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: LEFT ACHILLES CHRONIC PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk

Adverse event: DEHISCENCE WOUND
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 57 at risk
Study: NCT03782402

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

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk
Study: NCT03782545

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 34 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk
Study: NCT03782571

Adverse event: Unconfirmed Corneal Endothelium Keratic Precipitate
Serious: yes
Organ System: Eye disorders
Notes: Unconfirmed Corneal Endothelium Keratic Precipitate was reported in the right eye. The adverse event was deemed unrelated to the study by the investigator and the subject was discontinued.
Frequency: 1 affected / 25 at risk
Study: NCT03782701

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk

Adverse event: Eye Itchiness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 43 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk
Study: NCT03782987

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

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

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

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

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

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk
Study: NCT03783026

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 122 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 122 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 122 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 122 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 122 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 122 at risk
Study: NCT03783546

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 case grade-2 pain; 1 case grade-1 heart palpitations
Frequency: 1 affected / 39 at risk

Adverse event: heart palpitations
Serious: no
Organ System: Cardiac disorders
Notes: grade-1 heart palpitations
Frequency: 1 affected / 39 at risk
Study: NCT03783689

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Itching at bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Discoloration/bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin tear at pad site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain at lead site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Uncomfortable stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 19 at risk

Adverse event: Itching at bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Discoloration/bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Itching at bandage site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT03783780

Adverse event: Scraped skin
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subjects skin was scraped with scissors, no visual abrasion
Frequency: 1 affected / 21 at risk
Study: NCT03784027

Adverse event: Severe hypoglycaemia event
Serious: yes
Organ System: Endocrine disorders
Notes: The parents had set the nocturnal personal glucose target to 80 mg/dL. Before the severe hypoglycemia event, an audio alarm was issued overnight every 5 minutes for 3 hours. Alarms were acknowledged by the parents, but no hypo treatment was given.
Frequency: 1 affected / 73 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 73 at risk

Adverse event: Infection (Cold, UTI, D&V, fever)
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 73 at risk

Adverse event: Diabetes related
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 73 at risk

Adverse event: Other serious adverse event.
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospital admission for gastroenteritis
Frequency: 1 affected / 74 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 74 at risk

Adverse event: Infection (Cold, UTI, D&V, fever)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 74 at risk

Adverse event: Head injury
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk
Study: NCT03784300

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: lightheadedness upon standing was resported for a subject in the 100 mg group at 1 h post-dose
Frequency: 1 affected / 6 at risk

Adverse event: transient musculoskeletal wall pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One subject in the 200 mg group reported transient musculoskeletal wall pain
Frequency: 1 affected / 6 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The same subject in the 200 mg group who reported transient musculoskeletal wall pain, also reported acne
Frequency: 1 affected / 6 at risk
Study: NCT03784846

Adverse event: Participant contracted COVID-19
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk
Study: NCT03784963

Adverse event: nausea and indigestion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT03785145

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Suspected COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk
Study: NCT03785587

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Mydriasis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

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

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

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

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Decreased Appetitie
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk
Study: NCT03786224

Adverse event: Loss of Appetitie
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk

Adverse event: Worsening Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Worsening Suicidal Ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Increased Stress
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

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

Adverse event: Increased Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk