TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01476475

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 161 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 161 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 161 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 161 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 161 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 161 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 161 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 161 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 162 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 162 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: ECG signs of myocardial ischaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 162 at risk
Study: NCT01476644

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Events leading to deaths during participation in this four year observational trial were not study related. All deaths were reported to Wills Eye Hospital Institutional Review Board (IRB) before January 2017. No study intervention; no relationship.
Frequency: 5 affected / 161 at risk
Study: NCT01477320

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk
Study: NCT01477749

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gastroenteritis radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 47 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 47 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Citrate toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 47 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk
Study: NCT01477853

Adverse event: Intentional overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 55 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Intentional overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 56 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Intentional overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 55 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk
Study: NCT01477892

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: no self respiration for 20 sec
Frequency: 3 affected / 7 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: heart rate below 100/min
Frequency: 1 affected / 7 at risk
Study: NCT01478087

Adverse event: pulse drop
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: loss of vascular access
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: elevated INR
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT01478113

Adverse event: Insomnia and Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk
Study: NCT01478347

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk
Study: NCT01478620

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 125 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 125 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 125 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk
Study: NCT01478828

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: patient was diagnosed with profound rhabdomyolysis with CK values in excess of 100,000 IU/L.
Frequency: 1 affected / 2 at risk
Study: NCT01478854

Adverse event: Hospital admission for anticoagulation of venous thrombosis due to disease progression
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hospital admission for craniotomy for removal of tumor from disease progression.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Death due to disease progression.
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hospital admission for pneumonia.
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: ER treatment for multifocal hemmorrhage due to head injury from fall.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Hospital admission for progressive confusion. Treated for pneumatosis.
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Patient report of melanoma. Subsequently diagnosed mild/moderate melanocytic dysplasia.
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: ER due to seizure ending in car accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Admission to surgery of tumor within treatment field for glioblastoma.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: ER due to disorientation thought to be minor seizure.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 30 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 30 at risk
Study: NCT01479010

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT01479348

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk
Study: NCT01479439

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

Adverse event: Increase in serum creatinine >50% from baseline
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Decline in GFR >25% from baseline
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk
Study: NCT01479478

Adverse event: Any other anticipated or unanticipated life-threatening event:intra-uterine fetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 125 at risk
Study: NCT01479530

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 158 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 158 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 158 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 158 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 158 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 158 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 158 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 158 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 163 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Peripheral nerve injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 163 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Delusional perception
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 163 at risk

Adverse event: Venous stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 163 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 163 at risk
Study: NCT01479595

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 44 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 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: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk
Study: NCT01479621

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 104 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 104 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 104 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 104 at risk
Study: NCT01479777

Adverse event: Ankle Swelling (X-ray negative for bone fracture or dislocation)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported swelling and bruise on medial aspect of ankle X-ray negative for bone fracture, dislocation Resume FES stepping by taking precautions by giving ankles more support: ace bandage wrapping; wear ankle supportive running shoes (high tops)
Frequency: 2 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: FES was stopped. participant rested, and symptoms resolved. Did not affect continued participation in study
Frequency: 3 affected / 12 at risk

Adverse event: Increased tone in lower extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Increased tone did not interfere with FES stepping
Frequency: 3 affected / 12 at risk
Study: NCT01480297

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Severe hypoglycemia requiring emergency room treatment.
Frequency: 1 affected / 8 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 3 of 8 subjects reported tinnitus. Tinnitus is a known side effect of Salsalate. In all cases, the Tinnitus resolved with decrease in dose, or with cessation of Salsalate treatment.
Frequency: 3 affected / 8 at risk

Adverse event: Upper Respiratory Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold/Sinusitis
Frequency: 2 affected / 8 at risk

Adverse event: Increased Bleeding from Biopsy Site
Serious: no
Organ System: Surgical and medical procedures
Notes: Patient reported increased bleeding from a single biopsy site. Resolved with application of pressure.
Frequency: 1 affected / 8 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Notes: Patient (postmenopausal woman) reported an increase in hot flashes.
Frequency: 1 affected / 8 at risk

Adverse event: Cataract Removal
Serious: no
Organ System: Eye disorders
Notes: Scheduled removal of cataracts
Frequency: 1 affected / 8 at risk

Adverse event: Skin Biopsy of Suspicious Lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient with suspicious lesion of face - biopsy was benign.
Frequency: 1 affected / 8 at risk
Study: NCT01480843

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Subject passed away from unknown causes
Frequency: 3 affected / 65 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject hospitalized for bowel obstruction.
Frequency: 1 affected / 65 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: subject hospitalized for hysterectomy
Frequency: 1 affected / 65 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: 2 subjects had strokes and subsequent hospitalization, unrelated to study intervention.
Frequency: 3 affected / 65 at risk

Adverse event: Hospitalization for gout
Serious: yes
Organ System: General disorders
Notes: subject hospitalized for gout flare up, unrelated to study intervention.
Frequency: 1 affected / 65 at risk

Adverse event: Cardiac stent placed
Serious: yes
Organ System: Cardiac disorders
Notes: Subject hospitalized for cardiac stent placement. Unrelated to study intervention.
Frequency: 3 affected / 65 at risk

Adverse event: Hospitalization for internal bleeding
Serious: yes
Organ System: General disorders
Notes: Subject hospitalized due to internal bleeding from mediation unrelated to study intervention.
Frequency: 2 affected / 65 at risk

Adverse event: Hospitalization for Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: subject hospitalized for cellulitis unrelated to study intervention.
Frequency: 1 affected / 65 at risk

Adverse event: Hospitalization due to fall
Serious: yes
Organ System: General disorders
Notes: Subject tripped and fell, resulting in hospitalization. Unrelated to study procedures.
Frequency: 1 affected / 65 at risk

Adverse event: Hospitalization for Acute renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: hospitalization for acute on chronic renal failure, thought to be interstitial nephritis. Unrelated to study intervention
Frequency: 2 affected / 65 at risk

Adverse event: Prednisone Taper Needed
Serious: no
Organ System: General disorders
Notes: Subjects paused their time in the study due to the use of prednisone, unrelated to study intervention. Prednisone affected blood glucose readings during this time.
Frequency: 4 affected / 65 at risk