TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03814044

Adverse event: POST SURGICAL RIGHT HIP OSTEOARTHRITIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to device
Frequency: 1 affected / 58 at risk

Adverse event: REPEAT LEFT HIP LABRAL TEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unlikely related to device
Frequency: 1 affected / 58 at risk

Adverse event: RIGHT PSOAS TENDONITIS/SNAP
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 58 at risk

Adverse event: LEFT HIP LABRAL ACETABULAR RETEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 58 at risk

Adverse event: LEFT HIP LABRAL RETEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unlikely related to device
Frequency: 1 affected / 58 at risk

Adverse event: RIGHT LEG PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 58 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to device
Frequency: 1 affected / 93 at risk

Adverse event: RIGHT HIP LABRAL TEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unlikely related to device
Frequency: 1 affected / 93 at risk

Adverse event: LEFT HIP INTRA-ARTICULAR PAIN
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 93 at risk

Adverse event: HIP LABRAL TEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 2 affected / 93 at risk

Adverse event: LEFT HIP LABRAL RETEAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device
Frequency: 1 affected / 93 at risk

Adverse event: ILIOPSOAS TENDENOPATHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 7 affected / 93 at risk

Adverse event: HIP PAIN
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 4 affected / 93 at risk
Study: NCT03815006

Adverse event: Hospital admission
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 78 at risk

Adverse event: skin reaction due to sensor
Serious: no
Organ System: Product Issues
Notes: skin reaction due to sensor
Frequency: 1 affected / 78 at risk

Adverse event: Hospital admission
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 78 at risk
Study: NCT03815916

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 13 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Allergic cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT03815929

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Sinus tachycardia of unknown etiology after planned oophorectomy & liver procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash at patch site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Migraine with vomitting during blood pressure regulation baseline testing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Itching from patch site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Liver Infarct (extended hospital stay)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: non-focal Bile leak from disease resection (extended hospital stay)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash at patch site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Passed out after blood draw at CRTU
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Moderate bilateral pleural effusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Ovarian Cancer Stage IIIc high grade Serious Carcinoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: COVID 19
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bladder Issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache/vomitting/allergic reaction to MRI
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vaginal cuff dehiscence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain with intercourse, vaginal dryness, and low sex drive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vaginal cuff dehiscence with infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Estradiol gives burnt taste in mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT03816202

Adverse event: Cerebral Ischemia Injury
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Artery injury
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk
Study: NCT03816696

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

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

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

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

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

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk
Study: NCT03816761

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk
Study: NCT03817528

Adverse event: worsening of symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT03817684

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Rhabdomyolsis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 85 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 86 at risk
Study: NCT03818256

Adverse event: Hyperthermia malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 35 at risk

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

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 35 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk
Study: NCT03818399

Adverse event: Inpatient psychiatric treatment for schizoaffective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Heart flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Reduced appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

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

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Leg muscle cramps after fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Acute neck strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Acute back pain from moving
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Chronic neck pain associated with arthritis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Acute left knee pain with comorbid arthritis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Withdrawal symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT03818581

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Surgical and medical procedures
Notes: Serious case of neuropathy requiring surgical amputation.
Frequency: 1 affected / 22 at risk

Adverse event: Grogginess
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Grogginess
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

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

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

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

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

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

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk
Study: NCT03818672

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk
Study: NCT03818711

Adverse event: DKA
Serious: yes
Organ System: Endocrine disorders
Notes: ED Visit for DKA
Frequency: 2 affected / 75 at risk

Adverse event: Indicated Self-Harm or Suicidality
Serious: no
Organ System: Psychiatric disorders
Notes: Child endorsed the item "I deliberately try to hurt or kill myself" or "I think about killing myself" on the Youth Self Report measure. All events were followed up by the PI (a licensed clinical psychologist) and/or the clinic social worker.
Frequency: 7 affected / 75 at risk

Adverse event: DKA
Serious: yes
Organ System: Endocrine disorders
Notes: ED Visit for DKA
Frequency: 3 affected / 76 at risk

Adverse event: Indicated Self-Harm or Suicidality
Serious: no
Organ System: Psychiatric disorders
Notes: Child endorsed the item "I deliberately try to hurt or kill myself" or "I think about killing myself" on the Youth Self Report measure. All events were followed up by the PI (a licensed clinical psychologist) and/or the clinic social worker.
Frequency: 5 affected / 76 at risk
Study: NCT03818815

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 55 at risk

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Nasal discharge discolouration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 55 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 55 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 55 at risk

Adverse event: KAWASAKIS DISEASE
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 48 at risk
Study: NCT03818919

Adverse event: GI adverse effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes constipation, diarrhea, nausea, and upset stomach
Frequency: 8 affected / 17 at risk

Adverse event: GI adverse effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes constipation, diarrhea, nausea, and upset stomach
Frequency: 10 affected / 23 at risk
Study: NCT03819114

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Menstrual discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk
Study: NCT03819218

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT03819491

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: PULTACEOUS ANGINA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk
Study: NCT03819634

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: hyperglycemia unresponsive to a correction dose of insulin
Frequency: 6 affected / 24 at risk

Adverse event: ketotosis
Serious: no
Organ System: Endocrine disorders
Notes: ketosis with hyperglycemia
Frequency: 1 affected / 24 at risk

Adverse event: adhesive failure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk