TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01746173

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
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: Anal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk
Study: NCT01746368

Adverse event: Admission to acute psychiatric unit
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Admission to hospital
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT01746511

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: One infant in the glycerin suppository group had blood streaks in the stool, but this was after a non-indicated glycerin shave, given in error following the discontinuation of phototherapy
Frequency: 1 affected / 40 at risk
Study: NCT01746732

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 22 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk
Study: NCT01746745

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT01747330

Adverse event: infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: gastrointestinal spastic and hypermotility disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk
Study: NCT01747629

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pharyngeal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 84 at risk
Study: NCT01748045

Adverse event: Murmur
Serious: no
Organ System: Cardiac disorders
Notes: Infant developed a murmur consistent with peripheral pulmonic stenosis and anemia.
Frequency: 1 affected / 2 at risk
Study: NCT01748240

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 21 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea 3/21 (14.28)
Frequency: 3 affected / 21 at risk

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

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

Adverse event: undernutrition
Serious: no
Organ System: Gastrointestinal disorders
Notes: patients presented the undernutrition
Frequency: 1 affected / 21 at risk
Study: NCT01748695

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue (Sleepiness)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 25 at risk
Study: NCT01748760

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Non lethal suicide attempts and subsequent psychiatric hospitalization
Frequency: 4 affected / 19 at risk

Adverse event: Hospitalization for suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 19 at risk

Adverse event: ED visit for suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 19 at risk

Adverse event: ED for drug overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: ED for medical evaluation (e.g. frostbite)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Legal Issues
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 19 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Non lethal suicide attempts and subsequent psychiatric hospitalization
Frequency: 3 affected / 23 at risk

Adverse event: Hospitalization for suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 23 at risk
Study: NCT01748942

Adverse event: Pharyngeal haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 35 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 35 at risk

Adverse event: Lymphatic fistula
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 35 at risk

Adverse event: Readmission/failure to thrive
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 35 at risk

Adverse event: Abscess
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 35 at risk

Adverse event: Pharyngeal haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 33 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk
Study: NCT01748994

Adverse event: Vertigo (dizziness)
Serious: no
Organ System: Nervous system disorders
Notes: Participants reported feelings of dizziness and light-headedness after drinking the deuterium-labeled water.
Frequency: 4 affected / 31 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participants reported skin irritation, including inflammation, rash, and pain, at the site of the adipose tissue biopsy.
Frequency: 6 affected / 31 at risk

Adverse event: Gastrointestinal issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients reported gastrointestinal issues, including nausea, vomiting, constipation, loss of appetite, and flatulence during the study.
Frequency: 4 affected / 31 at risk

Adverse event: Skin hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A participant reported a hematoma after the adipose tissue biopsy.
Frequency: 1 affected / 31 at risk

Adverse event: Vertigo (dizziness)
Serious: no
Organ System: Nervous system disorders
Notes: Participants reported feelings of dizziness and light-headedness after drinking the deuterium-labeled water.
Frequency: 6 affected / 32 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participants reported skin irritation, including inflammation, rash, and pain, at the site of the adipose tissue biopsy.
Frequency: 6 affected / 32 at risk

Adverse event: Gastrointestinal issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients reported gastrointestinal issues, including nausea, vomiting, constipation, loss of appetite, and flatulence during the study.
Frequency: 3 affected / 32 at risk
Study: NCT01749033

Adverse event: Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia during the timeframe from removal of the airway to 24 hours after the airway removal.
Frequency: 83 affected / 147 at risk

Adverse event: Blood on OMA after removal of the OMA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The presence of blood on the OMA after removal from the airway/
Frequency: 26 affected / 147 at risk

Adverse event: Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia during the timeframe from removal of the airway to 24 hours after the airway removal.
Frequency: 80 affected / 145 at risk

Adverse event: Blood on OMA after removal of the OMA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The presence of blood on the OMA after removal from the airway/
Frequency: 24 affected / 145 at risk

Adverse event: Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia during the timeframe from removal of the airway to 24 hours after the airway removal.
Frequency: 78 affected / 149 at risk

Adverse event: Blood on OMA after removal of the OMA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The presence of blood on the OMA after removal from the airway/
Frequency: 13 affected / 149 at risk
Study: NCT01749293

Adverse event: Serious
Serious: yes
Organ System: Cardiac disorders
Notes: Subject became short of breath and tachycardic to 180 per ECG, B/P60/40 and O2 saturation 74%. Subject administered adenosine IV and his heart rate and shortness of breath improved
Frequency: 1 affected / 3 at risk
Study: NCT01749410

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk
Study: NCT01749605

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea and vomiting
Frequency: 1 affected / 17 at risk
Study: NCT01749631

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 97 at risk
Study: NCT01749735

Adverse event: Arm Pain
Serious: no
Organ System: General disorders
Notes: One subject experienced arm pain, an expected adverse event related to the performance of rehabilitation exercises. The subject chose not to complete the final evaluation visit. The subject's physician prescribed Advil and the problem was resolved.
Frequency: 1 affected / 2 at risk
Study: NCT01749904

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 283 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 283 at risk

Adverse event: Fracture of right femoral neck
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 283 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 283 at risk

Adverse event: torn rotator cuff
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 135 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 135 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 385 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 385 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 385 at risk

Adverse event: Recurrence of breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 385 at risk

Adverse event: Allergic angioedema due to Motrin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 385 at risk

Adverse event: Leg disco-ordination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 385 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 385 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 385 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 385 at risk

Adverse event: Right upper lobe lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 385 at risk

Adverse event: Dislocation of intraocular lens
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 385 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 385 at risk
Study: NCT01749930

Adverse event: left shoulder subluxation of acromioclavicular joint
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Scapular fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 279 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 279 at risk

Adverse event: Cholelethiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 279 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Other convulsions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 279 at risk

Adverse event: Pain in joint (shoulder)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 279 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 279 at risk

Adverse event: Subdural hermorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Closed fracture of distal end of ulna
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 279 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 279 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 279 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 279 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 136 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 136 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 136 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 384 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 384 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 384 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 384 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 384 at risk
Study: NCT01749982

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT01750086

Adverse event: Dizziness
Serious: yes
Organ System: Endocrine disorders
Notes: One subject experienced lightheadedness 3 hours after the first teriparatide injection
Frequency: 1 affected / 12 at risk

Adverse event: Syncope
Serious: yes
Organ System: Endocrine disorders
Notes: One subject experienced lightheadedness and syncope 3 hours after the first teriparatide injection
Frequency: 1 affected / 13 at risk
Study: NCT01750229

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk