TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02954575

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 55 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 55 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 55 at risk
Study: NCT02954601

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number of Hypoglycemic events during treatment period
Frequency: 2 affected / 31 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Metabolism and Nutrional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Muskuloskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number of Hypoglycemic events during treatment period
Frequency: 1 affected / 20 at risk

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

Adverse event: Metabolism and Nutrional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Muskuloskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number of Hypoglycemic events during treatment period
Frequency: 4 affected / 21 at risk

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

Adverse event: Metabolism and Nutrional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 21 at risk

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

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number of Hypoglycemic events during treatment period
Frequency: 1 affected / 20 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Metabolism and Nutrional Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk
Study: NCT02954848

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 245 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 245 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 238 at risk
Study: NCT02955147

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One patient developed mild diverticulitis, which was classified as a serious adverse event because it required hospitalization
Frequency: 1 affected / 13 at risk

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

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk
Study: NCT02955186

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 33 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: car accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk
Study: NCT02956434

Adverse event: Medication overdose
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant took more of their (non-study) psychiatric medication than was prescribed. No intervention was required.
Frequency: 1 affected / 10 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was involuntarily hospitalized following an aggressive episode
Frequency: 1 affected / 10 at risk
Study: NCT02956447

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk

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

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT02957305

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2 - medical intervention indicated
Frequency: 1 affected / 106 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2 - medical intervention indicated
Frequency: 1 affected / 105 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Cervical laceration occurred with Pozzi forceps traction. Local suture was performed without further treatment
Frequency: 2 affected / 105 at risk
Study: NCT02957331

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Rebound tachycardia occurred when propranolol was tapered off. A slower taper was used and this resolved the event.
Frequency: 1 affected / 13 at risk
Study: NCT02957747

Adverse event: IPV-Physical-Sought no medical care
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 76 at risk

Adverse event: IPV-Verbal threat
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalization-Appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalization-Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalization-General medical issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalization-Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 76 at risk

Adverse event: Sexual assault-Non-IPV
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 76 at risk

Adverse event: Physical assault-Non-IPV
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: IPV-Physical-Doctor's Visit
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalization-Vertigo
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: IPV-Physical-Sought no medical care
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 77 at risk

Adverse event: Hospitalization-General medical issue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hospitalization-Depression/Heavy drinking
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hospitalization-Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Hospitalization-General medical issue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Car accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Hospitalization-Inpatient-Psych
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 77 at risk

Adverse event: Feeling unsafe at home-heard gunshots in neighborhood
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 77 at risk
Study: NCT02957942

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Tenderness on Skin Area of Insertion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 7 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Other(fatigue)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Tenderness on Skin Area of Insertion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT02958007

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Lightheaded during exercise
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Leg wound- unrelated to exercise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hernia- unrelated to study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Acute hypoxic respiratory failure- unrelated to study
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: After randomization and prior to beginning fitness training, Veteran was admitted to hospital for acute encephalopathy, acute hypoxic respiratory failure and respiratory acidosis secondary to inhalant abuse. Veteran medically withdrawn from study.
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fell in his home
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anxious distress at gym
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk
Study: NCT02958267

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT02958553

Adverse event: Pancreatitis and ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Notes: Subject was hospitalized due to vomiting approximately 6 weeks prior to the 6 Month Study Visit. He was admitted and diagnosed with pancreatitis and ketoacidosis.
Frequency: 1 affected / 8 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Cardiac disorders
Notes: A subject reported having had an angioplasty procedure at the time of withdrawing consent. This event was not related to the device.
Frequency: 1 affected / 8 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Falls
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk
Study: NCT02958969

Adverse event: non-major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk
Study: NCT02959138

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

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

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

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

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

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
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: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk
Study: NCT02959307

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 31 at risk

Adverse event: Worsening of Pre-Existing Condition
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 31 at risk

Adverse event: Irritability With and Without Impulsivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pressure on Forehead/Head
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Aborted Suicide Attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Aborted suicide attempt that triggered a hospitalization while participant was outside of lab.
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 31 at risk

Adverse event: Worsening of Pre-Existing Condition
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 31 at risk

Adverse event: Irritability With and Without Impulsivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 31 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pressure on Forehead/Head
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk
Study: NCT02959671

Adverse event: Enamel Wear of the Maxillary Incisors
Serious: no
Organ System: Product Issues
Notes: Adverse device effect
Frequency: 2 affected / 31 at risk
Study: NCT02959775

Adverse event: erytherma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 158 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 158 at risk

Adverse event: erytherma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 156 at risk
Study: NCT02959853

Adverse event: Hospital admission
Serious: yes
Organ System: Psychiatric disorders
Notes: 034 admitted for suicidal ideation
Frequency: 1 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: heel pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: uncontrolled DM
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hospital
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Admitted for low back pain
Frequency: 1 affected / 12 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT02959892

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk