TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03900416

Adverse event: Suicide attempt
Serious: yes
Organ System: Social circumstances
Notes: An adolescent participant reported a suicide attempt on their survey. We immediately intervened with both the parent and child. This adolescent was already seeing a mental health professional.
Frequency: 1 affected / 72 at risk

Adverse event: Stress from noticing negative emotions
Serious: no
Organ System: Psychiatric disorders
Notes: Adolescents rated how anxious or sad they were feeling in the present moment when using the app. Some adolescents reported discomfort surrounding the acknowledgment of negative emotions.
Frequency: 1 affected / 72 at risk

Adverse event: Onset of Non-suicidal Self-Injury
Serious: no
Organ System: Psychiatric disorders
Notes: Adolescents reported the onset of self-injury.
Frequency: 2 affected / 72 at risk

Adverse event: Onset of Passive Suicidal Ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 72 at risk

Adverse event: Discomfort from Mindfulness Activity
Serious: no
Organ System: Psychiatric disorders
Notes: One adolescent reported focusing on sounds sometimes made them stressed when they were meditating in a chaotic environment.

Another participant noticed that they had a headache once when completing a mindfulness exercise from focusing.
Frequency: 2 affected / 72 at risk

Adverse event: Stress from noticing negative emotions
Serious: no
Organ System: Psychiatric disorders
Notes: Adolescents rated how anxious or sad they were feeling in the present moment when using the app. Some adolescents reported discomfort surrounding the acknowledgment of negative emotions.
Frequency: 3 affected / 80 at risk

Adverse event: Onset of Non-suicidal Self-Injury
Serious: no
Organ System: Psychiatric disorders
Notes: Adolescents reported the onset of self-injury.
Frequency: 1 affected / 80 at risk

Adverse event: Onset of Passive Suicidal Ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk
Study: NCT03900624

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Steroid induced hyperglycemia
Frequency: 7 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 61 at risk

Adverse event: Altered Mentation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Steroid induced hyperglycemia
Frequency: 2 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk
Study: NCT03900715

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 21 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

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

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 21 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 21 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 21 at risk
Study: NCT03901079

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk
Study: NCT03901144

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Application site papules
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Application site urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 49 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Application site bruise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Application site eczema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Application site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk
Study: NCT03901313

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk
Study: NCT03901326

Adverse event: Nonfatal myocardiol infraction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 587 at risk

Adverse event: Revascularization after 90 days
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 587 at risk

Adverse event: Hospitalization for unstable angina
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 587 at risk

Adverse event: Nonfatal myocardiol infraction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 589 at risk

Adverse event: Revascularization after 90 days
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 589 at risk

Adverse event: Hospitalization for unstable angina
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 589 at risk
Study: NCT03901456

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalization related to UTI
Frequency: 1 affected / 22 at risk

Adverse event: COVID
Serious: no
Organ System: Infections and infestations
Notes: Details uncertain \[unsure if doctor's visit required\]; documented as events for completeness
Frequency: 2 affected / 22 at risk

Adverse event: Initiate Anxiety Medication
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Initiate Thyroid Medication
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Eye surgery
Serious: no
Organ System: Eye disorders
Notes: Uncertain if planned or meets study definition of AE; documented for completeness
Frequency: 1 affected / 22 at risk

Adverse event: Multiple falls during study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vulnerable adult report
Serious: no
Organ System: General disorders
Notes: Filed for caregiver safety and falls; follow up call to APS also made later in study.
Frequency: 1 affected / 22 at risk

Adverse event: Hip issue [unspecified]
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Unknown/not specified medical concern
Serious: no
Organ System: General disorders
Notes: Staff were not provided details
Frequency: 1 affected / 21 at risk
Study: NCT03901482

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 363 at risk

Adverse event: Dyseusia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 363 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 363 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 363 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: The subject was hospitalized for pneumonia after study randomization but before use of study medication.
Frequency: 1 affected / 367 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 367 at risk

Adverse event: Dyseusia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 367 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 367 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 367 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 363 at risk

Adverse event: Dyseusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 363 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 363 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 363 at risk
Study: NCT03902418

Adverse event: Pregnancy Loss, Miscarriage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriages occurring at gestational age \<= 20 weeks among participants with available pregnancy outcomes
Frequency: 36 affected / 1145 at risk

Adverse event: Pregnancy Loss, Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Stillbirth occurring at gestational age \> 20 weeks among women with available pregnancy outcomes
Frequency: 25 affected / 1145 at risk

Adverse event: Live Birth Outcome, Neonatal Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Neonatal deaths observed among women with available pregnancy outcomes
Frequency: 6 affected / 1082 at risk

Adverse event: HIV sero-conversion
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 1195 at risk

Adverse event: Live Birth Outcome, Preterm Delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pre-term delivery (gestational age \< 37 weeks) among women with available pregnancy outcome
Frequency: 91 affected / 1082 at risk

Adverse event: Live Birth Outcome, Low Birth Weight
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Low infant birth weight (\<2500g) recorded among women with available pregnancy outcome
Frequency: 110 affected / 1082 at risk
Study: NCT03902574

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: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

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

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

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT03903640

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT03904446

Adverse event: Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Postpartum diagnosis of pregnancy-induced hypertension
Frequency: 7 affected / 80 at risk

Adverse event: Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Postpartum diagnosis of pregnancy-induced hypertension
Frequency: 9 affected / 80 at risk
Study: NCT03905798

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 112 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory arrest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory depression
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 112 at risk
Study: NCT03905811

Adverse event: Dizzy/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 8 at risk

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

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

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

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

Adverse event: Dizzy/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Unsteady
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT03905863

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Linked to cellulitis previously recorded as an AE
Frequency: 1 affected / 64 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: New Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 64 at risk

Adverse event: Falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 64 at risk

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 64 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound/leg pain
Frequency: 1 affected / 64 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 81 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Acute hypokalemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Associated hypotension and nonischemic cardiomyopathy
Frequency: 1 affected / 81 at risk

Adverse event: New Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 81 at risk

Adverse event: Falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 81 at risk

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 81 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound/leg pain
Frequency: 3 affected / 81 at risk
Study: NCT03906448

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Inpatient Hospitalization for repeat brain tumor resection
Frequency: 1 affected / 1 at risk

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

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Disease progression
Frequency: 1 affected / 1 at risk

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

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

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

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

Adverse event: Metastatic neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1 at risk
Study: NCT03906461

Adverse event: Cardiac Perforation or Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk
Study: NCT03907033

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Protruding sutures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 14 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk