TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00891995

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: General disorders
Notes: During inpatient hybrid closed-loop control (HCLC) therapy, one subject had an anaphylactic reaction following his first dinner, presumably resulting from a peanut allergy, and received intravenous steroids.
Frequency: 1 affected / 48 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: During follow up, in the intensive group, one participant with a prior history of depression developed suicidal ideation.
Frequency: 1 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Severe hypoglycemia occurred in one participant (two events, at 6 months while CGM was being used and 12 months after CGM had been discontinued) in the intensive group and in no participants in the usual care group.
Frequency: 1 affected / 48 at risk

Adverse event: Venous thrombosis
Serious: no
Organ System: Vascular disorders
Notes: There were two cases of venous thrombosis related to the intravenous line that resolved without consequence.
Frequency: 2 affected / 48 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: During follow up, in the intensive group, one participant fainted following the 3-month MMTT
Frequency: 1 affected / 48 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During follow up, in the intensive group, one participant had a skin infection related to the CGM sensor insertion.
Frequency: 1 affected / 48 at risk

Adverse event: Injury associated with device
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: On admission, during insertion of sensor into abdomen of patient, the skin was pinched up due to minimal body fat. The sensor entered subject's skin then exited other side and punctured nurse's thumb which resulted in cross contamination.
Frequency: 1 affected / 48 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: In the usual care group, one participant was hospitalized for gastroenteritis.
Frequency: 1 affected / 20 at risk

Adverse event: depression and anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: In the usual care group, two participants developed depression and anxiety.
Frequency: 2 affected / 20 at risk
Study: NCT00892047

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 91 at risk

Adverse event: hospitalization for MI or CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 91 at risk

Adverse event: diverticulitis or excessive vonmiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: hospitalization for MI or CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: diverticulitis or excessive vonmiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk
Study: NCT00892281

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1196 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1196 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1196 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1196 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1196 at risk
Study: NCT00892697

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Subarachnoid haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk
Study: NCT00893074

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 5 affected / 24 at risk
Study: NCT00893113

Adverse event: Syncope
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: The assesment in the hospital revealed unclear etiology and the subject was discharged with a treatment plan to continue with pre admission medications, activity and diet. The subject was discontinued from the trial via withdrawal of consent
Frequency: 1 affected / 36 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient was admitted to the hospital for Shortness of Breath, pleuritic right sided chest pain. Patient was discontinued from trial via Investigator discretion.
Frequency: 1 affected / 38 at risk
Study: NCT00893737

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Migraine without aura
Serious: yes
Organ System: Nervous system disorders
Notes: without intractable headache, but with Status Migrainosus
Frequency: 1 affected / 147 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 147 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 147 at risk

Adverse event: Jittery
Serious: no
Organ System: General disorders
Frequency: 3 affected / 147 at risk

Adverse event: Light Headed
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 147 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 147 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 147 at risk

Adverse event: Tired
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 147 at risk
Study: NCT00893984

Adverse event: Weight Gain/Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT00893997

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

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Chill
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Puritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00894413

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pt started feeling chest tightness, he was evaluated in ER and admitted. Pt was evaluated for cardiac issues \& a full cardiac workup was done. No cardiac problems were found was diagn as "acid reflux" and sent home with medication for acid reflux.
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Infection not related to study
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pt started feeling chest tightness, he was evaluated in ER and admitted. Pt was evaluated for cardiac issues \& a full cardiac workup was done. No cardiac problems were found was diagn as "acid reflux" and sent home with medication for acid reflux.
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Infection not related to study
Frequency: 1 affected / 25 at risk
Study: NCT00894517

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 29 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 29 at risk

Adverse event: Ejaculation delayed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 29 at risk

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

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

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

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 30 at risk
Study: NCT00894543

Adverse event: Fatigue, tiredness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 104 at risk

Adverse event: Difficulty sleeping/insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 14 affected / 104 at risk

Adverse event: Increased sweating
Serious: no
Organ System: General disorders
Frequency: 7 affected / 104 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 11 affected / 104 at risk

Adverse event: Stomach or intestinal problems
Serious: no
Organ System: General disorders
Frequency: 10 affected / 104 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: General disorders
Frequency: 11 affected / 104 at risk

Adverse event: Decreased sexual desire/ability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 104 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 8 affected / 104 at risk

Adverse event: Appetite changes
Serious: no
Organ System: General disorders
Frequency: 6 affected / 104 at risk

Adverse event: Other symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 104 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 104 at risk

Adverse event: Fatigue, tiredness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 101 at risk

Adverse event: Difficulty sleeping/insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 13 affected / 101 at risk

Adverse event: Increased sweating
Serious: no
Organ System: General disorders
Frequency: 9 affected / 101 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 12 affected / 101 at risk

Adverse event: Stomach or intestinal problems
Serious: no
Organ System: General disorders
Frequency: 18 affected / 101 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Decreased sexual desire/ability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 101 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 9 affected / 101 at risk

Adverse event: Appetite changes
Serious: no
Organ System: General disorders
Frequency: 4 affected / 101 at risk

Adverse event: Other symptoms
Serious: no
Organ System: General disorders
Frequency: 10 affected / 101 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk
Study: NCT00894686

Adverse event: Tenderness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk
Study: NCT00894699

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All events listed in this table were considered possibly or probably related to study drug
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk
Study: NCT00895011

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 99 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 99 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 99 at risk
Study: NCT00895245

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk
Study: NCT00895310

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Myocarditis
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Hypoantremia
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk
Study: NCT00895414

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: chest pain, NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT00895531

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk
Study: NCT00895752

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

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

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

Adverse event: Appetite Reduction
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk
Study: NCT00895921

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Akathisia: mild or greater severity by subjective complaints
Frequency: 1 affected / 15 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Akathisia: mild or greater severity by subjective complaints
Frequency: 7 affected / 15 at risk