TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03009110

Adverse event: Maternal ICU admission
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 806 at risk

Adverse event: Maternal Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 806 at risk

Adverse event: Postpartum hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 806 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 806 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 806 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 806 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 806 at risk

Adverse event: Maternal ICU admission
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 802 at risk

Adverse event: Maternal Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 802 at risk

Adverse event: Postpartum hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 802 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 802 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 802 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 802 at risk
Study: NCT03009162

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vessel puncture site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Foreign body in respiratory tract
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Procedural anxiety
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 8 at risk
Study: NCT03010462

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Self-injurious ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk
Study: NCT03011099

Adverse event: swelling and pain in foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT03011892

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 259 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 259 at risk
Study: NCT03012386

Adverse event: Pregnancy test positive
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Volunteer was terminated from the study due to positive and urine pregnancy tests
Frequency: 1 affected / 26 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Notes: non drug related event
Frequency: 1 affected / 26 at risk

Adverse event: Rash and itchiness all over the body
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash and pruritis was drug related. Subject responded to Hydroxyzine. No shortness of breath , no swelling and no wheezing was noted during the entire episode
Frequency: 2 affected / 26 at risk

Adverse event: Cough congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea frst 5 days of taking study medication
Frequency: 1 affected / 26 at risk

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

Adverse event: Burst of enerygy/ Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Low back pain/ Leg heaviness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk
Study: NCT03012594

Adverse event: Difficulty swallowing wireless motility capsule pill
Serious: no
Organ System: Investigations
Notes: One patient had difficulty in swallowing the wireless motility capsule and had a sensation that it was struck in the throat. Upon additional examination the subject was fine and was sent home.
Frequency: 1 affected / 9 at risk

Adverse event: Unable to acknowledge the passage of the wireless motility capsule through the feces
Serious: no
Organ System: Investigations
Notes: Subject was not able to acknowledge the passage of the wireless motility capsule through the feces after the end of 4 days after ingestion. An abdominal x-ray was performed to confirm that the capsule was indeed expelled.
Frequency: 1 affected / 9 at risk
Study: NCT03012815

Adverse event: Hypersensitivity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Angioedema attributed to allergic reaction to gabapentin
Frequency: 1 affected / 46 at risk
Study: NCT03012828

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

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT03014180

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Heart failure worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 60 at risk

Adverse event: Embolization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk
Study: NCT03014206

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Vaccination site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 684 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 684 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 684 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 684 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 684 at risk

Adverse event: Injection site hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 684 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 684 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Vaccination complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 684 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 684 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 684 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 684 at risk

Adverse event: Vaccination site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 684 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 684 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 684 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 684 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 36 affected / 684 at risk
Study: NCT03014362

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: Psychiatric disorders
Notes: Pain
Frequency: 18 affected / 59 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pain
Serious: no
Organ System: Psychiatric disorders
Notes: Pain
Frequency: 7 affected / 61 at risk
Study: NCT03014453

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 116 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 116 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 116 at risk

Adverse event: intermittent apnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 116 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 30 affected / 116 at risk

Adverse event: hypoxic ischemic injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 116 at risk

Adverse event: Re-hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 116 at risk

Adverse event: cough without cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: cough without cold at least once per week
Frequency: 44 affected / 116 at risk

Adverse event: Vomiting when feeding
Serious: no
Organ System: General disorders
Frequency: 45 affected / 116 at risk
Study: NCT03014479

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 110 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 110 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk
Study: NCT03014622

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 201 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 102 at risk
Study: NCT03014635

Adverse event: Uterine perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Uterine leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 205 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 205 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 205 at risk

Adverse event: Leiomyosarcoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk
Study: NCT03014674

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 85 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 79 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 80 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk
Study: NCT03014700

Adverse event: Chest Exploration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Infection (with positive culture within 14 days)
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Repeat Surgery (less than 7 days)
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated to study treatment
Frequency: 2 affected / 30 at risk

Adverse event: Arrhythmia requiring treatment
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to study treatment
Frequency: 6 affected / 30 at risk

Adverse event: Chest Exploration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study treatment
Frequency: 2 affected / 30 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis requiring Intervention
Serious: yes
Organ System: Vascular disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 30 at risk

Adverse event: Arrhythmia requiring treatment
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to study treatment
Frequency: 5 affected / 30 at risk
Study: NCT03015116

Adverse event: Numbness and Tingling
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2, probably not related to treatment
Frequency: 1 affected / 38 at risk
Study: NCT03015142

Adverse event: Pain right leg due to foramina stenosis by L5 screw. Screw was placed by free-hand.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Horner's syndrome
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Repeated Xper-CT
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Urticaria
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk
Study: NCT03016078

Adverse event: Redness at border of derssing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study subject had a distinctive border of redness where the silicone border was present. Subject denied any itching or pain at the incision site, but the PI confirmed it was an AE with a possible relation ADE.
Frequency: 1 affected / 21 at risk
Study: NCT03016091

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk