TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01530659

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 22 at risk

Adverse event: Reversible Cardiac Vasospasm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Total Eye Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 22 at risk

Adverse event: Clinically Significant Cystoid Macular Edema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Secondary Surgical Intervention (excluding Posterior Capsulotomy)
Serious: yes
Organ System: Eye disorders
Notes: Bilateral cataract extraction at 30 months required early NT-501 implant removal.
Frequency: 1 affected / 22 at risk

Adverse event: Ocular discomfort
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Reduced peripheral visual field
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pelvic fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 22 at risk

Adverse event: Reversible Cardiac Vasospasm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Total Eye Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Secondary Surgical Intervention (excluding Posterior Capsulotomy)
Serious: yes
Organ System: Eye disorders
Notes: Bilateral cataract extraction at 30 months required early NT-501 implant removal.
Frequency: 1 affected / 22 at risk

Adverse event: Pelvic fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk
Study: NCT01531205

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

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01531582

Adverse event: Seizure
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Seizure is a common characteristic of Angelman Syndrome (80%). Parent reported occurrence of seizure.
Frequency: 3 affected / 25 at risk

Adverse event: Lethargy/Sleepiness
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 25 at risk

Adverse event: Difficulty Ambulating
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 25 at risk

Adverse event: Darkening/discoloration over the anterior tibia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 25 at risk

Adverse event: Commencement of Menstruation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 25 at risk

Adverse event: Influenza Type A
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 25 at risk

Adverse event: Feminine yeast Infection
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 25 at risk
Study: NCT01531725

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 179 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 179 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 179 at risk

Adverse event: Non-cardiac death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 179 at risk

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 179 at risk
Study: NCT01531803

Adverse event: Superficial Wound Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Superficial wound infection of mild intensity. The subject was treated with 22.68 mg clindamycin intravenous every 6 hours (18 Feb 2015 to 23 Feb 2015). The AE resolved on 23 Feb 2015 and was considered to be not related to study drug.
Frequency: 1 affected / 2 at risk
Study: NCT01532128

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk
Study: NCT01532141

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk
Study: NCT01532349

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Renal and urinary disorders
Notes: (serum phosphorus \> 6.5 mg/dl in 1-5 year-olds, \> 5.8 in 6-12 year-olds, or \> 4.5 in 13-20 year-olds
Frequency: 1 affected / 17 at risk

Adverse event: Hypervitaminosis D
Serious: no
Organ System: Endocrine disorders
Notes: 25hydroxyvitamin D levels \> 60 ng/ml were noted at the 4-week visit
Frequency: 3 affected / 17 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Kidney stone incidentally noted on imaging
Frequency: 1 affected / 17 at risk
Study: NCT01532414

Adverse event: Upper respiratort tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 92 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 92 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratort tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk
Study: NCT01532518

Adverse event: Hospitalisation for investigation for suspected seizures
Serious: yes
Organ System: Surgical and medical procedures
Notes: 10 wks-old male-familiar history of seizure disorders.It started 6days after the last drug intake (nepadutant 0.1mg/kg early terminate after 3drug intakes).It reported as "moderate","not related" to nepadutant by investigator. It resolved: no sequel.
Frequency: 1 affected / 21 at risk

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

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

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

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

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

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Laryngeal Edema-post intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Prolongation of hospitalization due to post-intubation laryngeal edema in a 22wks-old female.It started 4days after the end of the 2weeks of treatment:it reported as "moderate","not related" to the treatment by investigators.It resolved:no sequel.
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

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

Adverse event: Upper respiratory atract congestion
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: Seborrhoic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01532648

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 255 at risk

Adverse event: Pancreatitis active
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 255 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 255 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 255 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 255 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 255 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 255 at risk
Study: NCT01532817

Adverse event: Local site neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased chest congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sensation of muscle tightness/spasm from right ear to right wrist
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased mucus in post oropharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Faint localised area of erythema on anterior biceps bilaterally
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper body jitteriness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sensation of musculoskeletal tenseness/tightness through upper body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Right neck skin itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tingling sensation on right side of neck
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Torticollis muscular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Viral respiratory syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk
Study: NCT01532830

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Discomfort to the neck into the upper right shoulder with tingling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 30 at risk

Adverse event: Neck twitched a little during use of the device
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lip drooping during use of the device
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Facial drooping
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Raspiness of voice
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

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

Adverse event: Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Right shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Right shoulder spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tinnitus left ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk
Study: NCT01532999

Adverse event: wisdom tooth infection
Serious: yes
Organ System: Infections and infestations
Notes: wisdom tooth infection requiring medical inpatient hospitalization
Frequency: 1 affected / 96 at risk

Adverse event: suicidal and homicidal feelings
Serious: yes
Organ System: Psychiatric disorders
Notes: suicidal and homicidal feelings; not related to study or intervention, resulting in psychiatric inpatient admission
Frequency: 3 affected / 96 at risk

Adverse event: suicidal and homicidal feelings
Serious: yes
Organ System: Psychiatric disorders
Notes: suicidal and homicidal feelings; not related to study or intervention, resulting in psychiatric inpatient admission
Frequency: 2 affected / 95 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension; preexisting coronary artery disease; unrelated to study or intervention; resulting in medical inpatient hospitalization
Frequency: 1 affected / 95 at risk

Adverse event: swollen scrotum
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: medical inpatient hospitalized for swollen scrotum; unrelated to study or intervention
Frequency: 1 affected / 95 at risk
Study: NCT01533259

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 48 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 48 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 48 at risk