TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03372382

Adverse event: nausea / emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-opioid group: 2 opioid group: 5
Frequency: 2 affected / 85 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: constipation
Frequency: 7 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: somnolence
Frequency: 4 affected / 85 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: reflux
Frequency: 1 affected / 85 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: itching
Frequency: 1 affected / 85 at risk

Adverse event: nausea / emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-opioid group: 2 opioid group: 5
Frequency: 4 affected / 85 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: constipation
Frequency: 13 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: somnolence
Frequency: 13 affected / 85 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: reflux
Frequency: 2 affected / 85 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: itching
Frequency: 2 affected / 85 at risk
Study: NCT03372928

Adverse event: mild erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-serious adverse event, very mild erythema. No cellulitis or e/o abscess. No significant pain or tenderness. Diagnosis: contact dermitits.
Frequency: 1 affected / 10 at risk
Study: NCT03373110

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Notes: suicidal thoughts were not severe and were unrelated to the current study
Frequency: 43 affected / 144 at risk

Adverse event: Negative health event
Serious: no
Organ System: Psychiatric disorders
Notes: Event that caused disruption in ability to conduct normal life (not specified)
Frequency: 7 affected / 144 at risk

Adverse event: Joint injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cardiovascular procedure
Serious: no
Organ System: Cardiac disorders
Notes: Echocardiogram, cardiac stress test
Frequency: 2 affected / 144 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalized for Angina (coronary artery disease)
Frequency: 1 affected / 145 at risk

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Notes: suicidal thoughts were not severe and were unrelated to the current study
Frequency: 39 affected / 145 at risk

Adverse event: Negative health event
Serious: no
Organ System: Psychiatric disorders
Notes: Event that caused disruption in ability to conduct normal life (not specified)
Frequency: 5 affected / 145 at risk

Adverse event: Hospitalized for alcoholism
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 145 at risk

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Notes: suicidal thoughts were not severe and were unrelated to the current study
Frequency: 23 affected / 72 at risk

Adverse event: Sleeping difficulty
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Negative health event
Serious: no
Organ System: Psychiatric disorders
Notes: Event that caused disruption in ability to conduct normal life (not specified)
Frequency: 5 affected / 72 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk
Study: NCT03373201

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: There was only one serious adverse event of atrial fibrillation in a subject receiving tasimelteon that was assessed as unrelated to study treatment and related to previously undiagnosed hyperthyroidism.
Frequency: 1 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 160 at risk
Study: NCT03373240

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk
Study: NCT03373435

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

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

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

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

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk
Study: NCT03373890

Adverse event: Mild severity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: fall while walking down stairs at home not during treadmill training
Frequency: 1 affected / 6 at risk

Adverse event: Mild possibly related to study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: blister from new Ankle Foot Orthoses (AFO)
Frequency: 1 affected / 6 at risk
Study: NCT03374202

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk
Study: NCT03374358

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 24 at risk

Adverse event: Gastrointestinal (diarrhoea, nausea)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 24 at risk

Adverse event: Sleeping difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 24 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 24 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 24 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 19 at risk

Adverse event: Gastrointestinal (diarrhoea, nausea)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Sleeping difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 19 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 19 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 19 at risk
Study: NCT03374787

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

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

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Cholesteatoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT03374891

Adverse event: Incomplete consent process
Serious: no
Organ System: Investigations
Notes: Participants consented verbally, which was not an complete consent process due to HIPAA written consent requirements. HIPAA waiver later obtained. Only participants enrolled at 1 site with separate written HIPAA authorization were at risk.
Frequency: 3 affected / 9 at risk
Study: NCT03374956

Adverse event: During study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 93 at risk

Adverse event: During study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 100 at risk
Study: NCT03375294

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

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

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

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

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

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

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

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye 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: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT03376516

Adverse event: Cryptochidism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: One patient had a treatment emergent adverse event (TEAE) that was classified as serious because it required hospitalisation for surgery. The adverse event was judged as moderate and not related to Wilate.
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

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

Adverse event: Parvovirus B19 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk
Study: NCT03377049

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: External Ventricular Drainage infection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk
Study: NCT03377634

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: small intestinal bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk
Study: NCT03377803

Adverse event: Application site vesicles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site vesicles
Frequency: 141 affected / 150 at risk

Adverse event: Application site scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site scab
Frequency: 85 affected / 150 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site pruritus
Frequency: 65 affected / 150 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site erythema
Frequency: 70 affected / 150 at risk

Adverse event: Application site dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site dryness
Frequency: 39 affected / 150 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site discolouration
Frequency: 46 affected / 150 at risk

Adverse event: Application site erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site erosion
Frequency: 12 affected / 150 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Application site Pain
Frequency: 83 affected / 150 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Application site oedema
Frequency: 8 affected / 150 at risk

Adverse event: Application site vesicles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site vesicles
Frequency: 34 affected / 112 at risk

Adverse event: Application site scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site scab
Frequency: 22 affected / 112 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site pruritus
Frequency: 37 affected / 112 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site erythema
Frequency: 28 affected / 112 at risk

Adverse event: Application site dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site dryness
Frequency: 20 affected / 112 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Application site discolouration
Frequency: 9 affected / 112 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Application site Pain
Frequency: 16 affected / 112 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Application site oedema
Frequency: 4 affected / 112 at risk
Study: NCT03377816

Adverse event: disease progression AE
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: disease progression AE
Frequency: 1 affected / 146 at risk

Adverse event: prolonged hospitalization AE
Serious: yes
Organ System: General disorders
Notes: The participant is hospitalized due to a health condition
Frequency: 2 affected / 146 at risk

Adverse event: surgery adverse event reporting
Serious: yes
Organ System: Surgical and medical procedures
Notes: Entered into an implant removal surgery with infection
Frequency: 4 affected / 146 at risk

Adverse event: Car accident
Serious: yes
Organ System: General disorders
Notes: Pain from car accident
Frequency: 1 affected / 146 at risk

Adverse event: COVID-19
Serious: no
Organ System: General disorders
Notes: Participant diagnosed with covid and could not continue participation
Frequency: 3 affected / 146 at risk

Adverse event: Side effect from medication or vaccine- not study related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 146 at risk

Adverse event: In mourning
Serious: no
Organ System: Social circumstances
Notes: Participant relative or close friend died, so did not attend
Frequency: 1 affected / 146 at risk

Adverse event: Stress from family illness
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 146 at risk

Adverse event: War
Serious: no
Organ System: Social circumstances
Notes: Participants not attending/ stress from war situation
Frequency: 6 affected / 146 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Notes: Participant broke leg
Frequency: 1 affected / 146 at risk

Adverse event: Medication
Serious: no
Organ System: General disorders
Notes: Participant did not provide ECG because of a medication she is taking for pain
Frequency: 1 affected / 146 at risk

Adverse event: disease progression AE
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: disease progression AE
Frequency: 1 affected / 143 at risk

Adverse event: prolonged hospitalization AE
Serious: yes
Organ System: General disorders
Notes: The participant is hospitalized due to a health condition
Frequency: 1 affected / 143 at risk

Adverse event: surgery adverse event reporting
Serious: yes
Organ System: Surgical and medical procedures
Notes: Entered into an implant removal surgery with infection
Frequency: 4 affected / 143 at risk

Adverse event: COVID-19
Serious: no
Organ System: General disorders
Notes: Participant diagnosed with covid and could not continue participation
Frequency: 3 affected / 143 at risk

Adverse event: In mourning
Serious: no
Organ System: Social circumstances
Notes: Participant relative or close friend died, so did not attend
Frequency: 1 affected / 143 at risk

Adverse event: War
Serious: no
Organ System: Social circumstances
Notes: Participants not attending/ stress from war situation
Frequency: 11 affected / 143 at risk