TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02944617

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hand-foot Syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

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

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

Adverse event: Diarhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Hand-foot Syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Diarhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk
Study: NCT02944656

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Increased nausea and vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk
Study: NCT02945046

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 59 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

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

Adverse event: Cluster headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 55 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk
Study: NCT02945410

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT02945553

Adverse event: Re-injury of ACL (graft failure)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient re-injured ACL/tore ACL graft several weeks after completing final study assessments while engaging in sporting activity.
Frequency: 1 affected / 11 at risk

Adverse event: Re-injury of meniscus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient re-injured damaged meniscus during 6-month post-surgery follow-up.
Frequency: 1 affected / 11 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experienced muscle strain during muscle strength assessment.
Frequency: 1 affected / 14 at risk

Adverse event: Procedural complication.
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient developed rash related to antiseptic used during muscle biopsy procedure.
Frequency: 1 affected / 14 at risk
Study: NCT02945657

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk
Study: NCT02946021

Adverse event: Pain/Discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Skin irritation on day 11 of use.
Frequency: 1 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema around 3 ICG injection sites.
Frequency: 1 affected / 5 at risk

Adverse event: Infection (fungal)
Serious: no
Organ System: Infections and infestations
Notes: Oral thrush.
Frequency: 1 affected / 5 at risk
Study: NCT02946034

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Occurred 30 weeks post-treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Occurred 19 weeks post-treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Fall / loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: Occurred 22 weeks post-treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Occurred 29 weeks post-treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Cryoglobulinemic glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Occurred week 2 of treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Occurred week 5 of treatment, deemed possibly related to study drug (digoxin interaction with Mavyret).
Frequency: 1 affected / 10 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Cardiac disorders
Notes: Occurred 39 weeks post-treatment, was deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: muscle pain in leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported at week 12 visit, deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Observed at week 12 visit, deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: For one patient, reported at week 8 visit, deemed possibly related to study drug.

For another, reported at week 4 visit, deemed possibly related to study drug.

For another, reported at week 2 visit, deemed possibly related to study drug.
Frequency: 3 affected / 10 at risk

Adverse event: Cryoglobulinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Observed at week 1 visit, deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: slow ventricular response
Serious: no
Organ System: Cardiac disorders
Notes: Observed at week 8 visit and 12-weeks post treatment, deemed not related to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: high potassium
Serious: no
Organ System: Renal and urinary disorders
Notes: Observed at week 1 of treatment, deemed not related to study drug.
Frequency: 1 affected / 10 at risk
Study: NCT02946047

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash, maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash, maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT02946255

Adverse event: Hospitalizations (Inpatient)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 22 at risk

Adverse event: Hospitalizations (Inpatient)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 41 at risk

Adverse event: Hospitalizations (Inpatient)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 44 at risk
Study: NCT02946580

Adverse event: Constipation resulting in re-admission to Emergency Department
Serious: no
Organ System: Gastrointestinal disorders
Notes: Admission to emergency department on day 4 post discharge due to constipation
Frequency: 1 affected / 28 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk
Study: NCT02946788

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

Adverse event: facial dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT02946853

Adverse event: Hospitalization with heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hospitalization with heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk
Study: NCT02946892

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Low Heart Rate
Frequency: 4 affected / 25 at risk
Study: NCT02946918

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02947048

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

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

Adverse event: intentional self injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: ear infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: blood TSH increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Crystal urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

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

Adverse event: intentional self injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk
Study: NCT02947100

Adverse event: Phlebitis superficial
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Subject developed Mondor's disease one month after study drug was stopped due to study suspension. Admitted to hospital for one night of observation, resolved without treatment. The SAE was deemed unrelated to study medication.
Frequency: 1 affected / 1 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: influenza B, unlikely related to study medication
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach cramping and constipation. Unlikely related to study medication as this was a preexisting problem.
Frequency: 1 affected / 3 at risk

Adverse event: vasoocclusive crisis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: painful vasoocclusive crisis related to sickle cell disease, unlikely related to study medication
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: transient nausea, unlikely related to study medication.
Frequency: 1 affected / 3 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Notes: stye left lower eyelid, unlikely related to study medication
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: eczematous rash, unlikely related to study drug
Frequency: 1 affected / 3 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: self limited, less than 5 minutes, unlikely related to study medication
Frequency: 1 affected / 3 at risk
Study: NCT02947646

Adverse event: Unexpected bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unexpected bleeding with first lancet puncture (vibration off). Required pressure to site for \>12 min to stop bleeding. PI elected to stop study for this enrollee and not perform procedure with vibration on.
Frequency: 1 affected / 20 at risk
Study: NCT02948257

Adverse event: Chronic osteomyelitis of ankle/foot
Serious: yes
Organ System: Infections and infestations
Notes: Chronic osteomyelitis of ankle/foot
Frequency: 1 affected / 52 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 2 affected / 52 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 52 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute Kidney Injury
Frequency: 1 affected / 52 at risk

Adverse event: Access site arterial re-bleeding after initial hemostasis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Access site arterial re-bleeding after initial hemostasis
Frequency: 1 affected / 52 at risk

Adverse event: Residual hematoma < 6 cm
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Residual hematoma \< 6 cm
Frequency: 2 affected / 52 at risk

Adverse event: Tissue tract oozing - prolonged
Serious: no
Organ System: Infections and infestations
Notes: Tissue tract oozing - prolonged
Frequency: 2 affected / 52 at risk

Adverse event: Pseudoaneurysm not requiring repair
Serious: no
Organ System: Cardiac disorders
Notes: Pseudoaneurysm not requiring repair
Frequency: 1 affected / 52 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bruising
Frequency: 1 affected / 52 at risk

Adverse event: Groin pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Groin pain
Frequency: 1 affected / 52 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Angina
Frequency: 1 affected / 52 at risk

Adverse event: Worsening PVD
Serious: no
Organ System: Vascular disorders
Notes: Worsening PVD
Frequency: 4 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 1 affected / 52 at risk

Adverse event: Mechanical Fall
Serious: no
Organ System: General disorders
Notes: Mechanicall Fall
Frequency: 1 affected / 52 at risk
Study: NCT02948400

Adverse event: Motion sickness
Serious: no
Organ System: Nervous system disorders
Notes: participant experienced possible fainting episode due to motion sickness
Frequency: 1 affected / 254 at risk
Study: NCT02948569

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The possibility of hair loss is listed in the consent form and, given that the effect of this drug is to lower body oil synthesis, the mechanism for this AE is likely a reduction in the oil production at the base of the hair follicle.
Frequency: 2 affected / 12 at risk