TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03440047

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 355 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Gastric ulcers
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 355 at risk

Adverse event: Perirectal abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 355 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Fall secondary to syncope
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Opioid overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 355 at risk

Adverse event: Clostridium difficile
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 355 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 355 at risk
Study: NCT03440229

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT03440320

Adverse event: High blood pressure
Serious: yes
Organ System: Cardiac disorders
Notes: SAE did not occur during active intervention/control. Participant hospitalized for high blood pressure and dizziness, received care and released with new medication. Resumed sessions with med clearance. SAE deemed not related to study by IRB.
Frequency: 1 affected / 18 at risk

Adverse event: Extreme leg pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE did not happen during active intervention/control. Participant hospitalized for extreme leg pain, received care, and released. Returned the next week, resumed sessions with med clearance. The SAE was deemed not related to the study by the IRB.
Frequency: 1 affected / 14 at risk
Study: NCT03440424

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

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

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

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 8 at risk
Study: NCT03440840

Adverse event: Reactivation of traumatic memories
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk
Study: NCT03440944

Adverse event: Device failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Device failure due to either pain, swelling, being dislodged, infiltration, or other failure such as inability to provide medications.
Frequency: 6 affected / 8 at risk

Adverse event: Device failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Device failure due to either pain, swelling, being dislodged, infiltration, or other failure such as inability to provide medications.
Frequency: 1 affected / 8 at risk
Study: NCT03441178

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 101 at risk

Adverse event: Gastrointestinal anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 101 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 101 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 101 at risk

Adverse event: Anastomotic leak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 101 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 101 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk
Study: NCT03441477

Adverse event: Punctate epithelial erosions
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 225 at risk
Study: NCT03441581

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 12 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

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

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

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

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

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

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT03441984

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Vessel puncture site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk
Study: NCT03442036

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk
Study: NCT03442088

Adverse event: Nausea
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: Sinus/viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Arthroscopic procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 28 at risk

Adverse event: Contact dermatitis to watch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Psoriasis flare
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

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

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

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

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

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT03442595

Adverse event: worsening pre-existing heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Patient with preexisting class III/IV heart failure required hospitalization and LVAD placement. Was withdrawn from the boot cam due to extended hospital stay
Frequency: 1 affected / 460 at risk

Adverse event: Chest pain requiring hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Patient with know history of CHF and CADA.
Frequency: 2 affected / 460 at risk

Adverse event: New diagnosis of breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: AE classified as unrelated to Boot Camp as patient had not been started on any new medications. Patient self-withdrew from the Boot Camp after receiving diagnosis and was lost to follow up.
Frequency: 1 affected / 460 at risk

Adverse event: Deep vein Thrombosis requiring intervention
Serious: yes
Organ System: Vascular disorders
Notes: Patient had a history of vascular problems
Frequency: 1 affected / 460 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: New diagnosis of diabetic neuropathy in patients with long standing type 2 DM
Frequency: 3 affected / 460 at risk
Study: NCT03442699

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: patient vomited during one of the CBT sessions.
Frequency: 1 affected / 6 at risk
Study: NCT03442725

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT03442777

Adverse event: Pressure ulcer development
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Note: two of these pressure ulcers were category 1 and one was category 2
Frequency: 1 affected / 539 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 539 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 539 at risk

Adverse event: Blister formation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 539 at risk

Adverse event: Mechanical skin injuries
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 539 at risk

Adverse event: Patient fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 539 at risk

Adverse event: Pain at sacrum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 539 at risk

Adverse event: Pressure ulcer development
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Note: two of these pressure ulcers were category 1 and one was category 2
Frequency: 2 affected / 538 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 538 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Blister formation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Exacerbates athlete's foot
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Mechanical skin injuries
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 538 at risk
Study: NCT03442868

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 1 participant reported mild headache after stimulation. The headache was resolved about 2 hours after the session ended.
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: 1 participant was admitted to the hospital between the1st and the 2nd visit due to a lung infection.

The event was deemed unrelated to the study.
Frequency: 1 affected / 15 at risk
Study: NCT03443063

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 8 at risk
Study: NCT03443388

Adverse event: Minor abrasions/head lacerations
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4 at risk
Study: NCT03443687

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: 2 UTIs in PFPT
Frequency: 2 affected / 27 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: 1 BV in PT group, 1 yeast in home biofeedback
Frequency: 1 affected / 27 at risk

Adverse event: Vaginal discharge without infection
Serious: no
Organ System: Infections and infestations
Notes: One vaginal discharge without infection
Frequency: 1 affected / 27 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: 1 BV in PT group, 1 yeast in home biofeedback
Frequency: 1 affected / 27 at risk
Study: NCT03443713

Adverse event: redness and swelling at sensor site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Limb injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Work-related muscle injury
Frequency: 1 affected / 9 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk
Study: NCT03444038

Adverse event: Infected bite
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 85 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 85 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 85 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 85 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 85 at risk
Study: NCT03444155

Adverse event: Flush
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk