TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02500628

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 5 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 38 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 2 affected / 23 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 23 at risk
Study: NCT02501265

Adverse event: Hospitalization related to pulmonary infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Report of any: Vivid Dreams, Constipation, Dry Mouth, Dizziness, Headache, Insomnia, Nausea, Anxiety
Serious: no
Organ System: General disorders
Frequency: 48 affected / 63 at risk

Adverse event: Report of any: Vivid Dreams, Constipation, Dry Mouth, Dizziness, Headache, Insomnia, Nausea, Anxiety
Serious: no
Organ System: General disorders
Frequency: 25 affected / 30 at risk

Adverse event: Hospitalization related to pulmonary infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Report of any: Vivid Dreams, Constipation, Dry Mouth, Dizziness, Headache, Insomnia, Nausea, Anxiety
Serious: no
Organ System: General disorders
Frequency: 58 affected / 64 at risk

Adverse event: Report of any: Vivid Dreams, Constipation, Dry Mouth, Dizziness, Headache, Insomnia, Nausea, Anxiety
Serious: no
Organ System: General disorders
Frequency: 25 affected / 31 at risk
Study: NCT02501538

Adverse event: Celluliltis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unilateral leg cellulitis, nonstudy leg
Frequency: 1 affected / 23 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Abrasion from offloading boot
Frequency: 1 affected / 23 at risk

Adverse event: Foot swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling of study foot
Frequency: 1 affected / 23 at risk
Study: NCT02502019

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Non-occlusive thrombus and nonresponsiveness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pancreatic leak
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Syncopy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Non-serious AE
Serious: no
Organ System: General disorders
Frequency: 15 affected / 27 at risk
Study: NCT02502071

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Patient asked to fast and had a low serum blood glucose (31 mg/dl) with a normal point of care glucose (90 mg/dl) in clinic. Patient contacted upon receipt of serum glucose results. Patient asymptomatic with a normal glucose at the time of call.
Frequency: 1 affected / 45 at risk
Study: NCT02502149

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk
Study: NCT02502383

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Frequency: 15 affected / 504 at risk

Adverse event: Met criteria for eating disorder (anorexia, bulimia)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 504 at risk

Adverse event: Development of hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 487 at risk

Adverse event: Development of hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 487 at risk
Study: NCT02502526

Adverse event: Posterior capsule rupture
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Vitreous loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 57 at risk

Adverse event: Corneal endothelial cell loss
Serious: no
Organ System: Eye disorders
Notes: Inclusive of any cell loss \>20% or under 1,500 cells/mm\^2
Frequency: 14 affected / 57 at risk

Adverse event: Corneal endothelial cell loss
Serious: no
Organ System: Eye disorders
Notes: Inclusive of any cell loss \>20% or under 1,500 cells/mm\^2
Frequency: 17 affected / 57 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 59 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Corneal endothelial cell loss
Serious: no
Organ System: Eye disorders
Notes: Inclusive of any cell loss \>20% or under 1,500 cells/mm\^2
Frequency: 11 affected / 59 at risk
Study: NCT02502734

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 58 at risk
Study: NCT02502799

Adverse event: Admitted to in-patient psychiatric unit
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant admitted to in-patient psychiatric unit; however, hospitalization was not related to participation in the study.
Frequency: 1 affected / 17 at risk

Adverse event: Admitted to in-patient psychiatric unit
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant admitted to in-patient psychiatric unit; however, hospitalization was not related to participation in the study.
Frequency: 1 affected / 16 at risk
Study: NCT02503085

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

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

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT02503540

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk
Study: NCT02503735

Adverse event: intestinal blockage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This severe adverse event (SAE) required hospitalization occurred 4 weeks after completing LDV/SOF. The intestinal condition was pre-existing and the SAE was deemed unrelated to study participation by the principal investigator.
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

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

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

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

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

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

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

Adverse event: elevated blood prsesure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: fall / twisted ankle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT02503787

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain in Bilateral Feet
Frequency: 1 affected / 48 at risk

Adverse event: Paraesthesia (uncomfortable sensation)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 48 at risk

Adverse event: Implant site warmth
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk
Study: NCT02503852

Adverse event: Brusing or Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: At liposuction or donor site, with or without pain
Frequency: 5 affected / 16 at risk

Adverse event: Brusing or Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: At liposuction or donor site, with or without pain
Frequency: 8 affected / 22 at risk

Adverse event: Hickups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Brusing or Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: At liposuction or donor site, with or without pain
Frequency: 11 affected / 24 at risk

Adverse event: Shilgles
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Brusing or Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: At liposuction or donor site, with or without pain
Frequency: 2 affected / 9 at risk
Study: NCT02503865

Adverse event: Indigestions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diarrhea, itching, gastritis
Frequency: 29 affected / 65 at risk

Adverse event: hypertermia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 65 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 65 at risk

Adverse event: Indigestions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diarrhea, itching, gastritis
Frequency: 26 affected / 222 at risk

Adverse event: hypertermia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 222 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 222 at risk
Study: NCT02503982

Adverse event: Hematologic toxicity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 13 at risk
Study: NCT02504099

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT02504424

Adverse event: Cellulitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 50 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Seroma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: neutropenic fever, weakness
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: inflammation (red breast syndrome)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 50 at risk

Adverse event: Seroma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 50 at risk
Study: NCT02504541

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Notes: VISUAL CHANGES OF NON-NEUROLOGIC ETIOLOGY
Frequency: 1 affected / 133 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 133 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: RIGHT KNEE SEPTIC ARTHRITIS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Prinzmetal angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: NON ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION
Frequency: 1 affected / 133 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: NON-SUSTAINED VENTRICULAR TACHYCARDIA
Frequency: 1 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 133 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 133 at risk

Adverse event: Haematocrit increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 133 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 133 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 133 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 133 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 133 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 133 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 133 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 133 at risk
Study: NCT02504554

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One participant experienced a rash on their body after taking the vancomycin (flavored with natural orange). The vancomycin was stopped, the rash disappeared, and a non-flavored vancomycin was then administered without adverse effect
Frequency: 1 affected / 18 at risk

Adverse event: nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 participant experienced nausea and vomiting with the first of the high-dose microbiota. She was switched to the rectal group, which was tolerated without adverse effect
Frequency: 1 affected / 18 at risk

Adverse event: hyperactivity and/or irritability
Serious: no
Organ System: Nervous system disorders
Notes: Within 1-4 days after the start of the vancomycin, 12 children with ASD had a temporary hyperactivity (7 cases) or tantrums/aggression (5 cases). The symptoms lasted 1-3 days in most cases, but one participant had symptoms lasting for 3 weeks.
Frequency: 12 affected / 18 at risk
Study: NCT02504619

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02504723

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 60 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: dyspnea on exertion
Serious: no
Organ System: General disorders
Frequency: 8 affected / 60 at risk

Adverse event: poor gastric ulcer healing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

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

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

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

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

Adverse event: poor gastric ulcer healing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: recurrent bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk
Study: NCT02504866

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Metatarsalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

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

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

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk