TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02178553

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Re-intubation and mechanical ventilation after surgery
Frequency: 4 affected / 46 at risk

Adverse event: Prolonged hospital stay
Serious: yes
Organ System: Surgical and medical procedures
Notes: Prolongation of existing hospitalization
Frequency: 1 affected / 46 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritis during hospitalization
Frequency: 3 affected / 46 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Re-intubation and mechanical ventilation after surgery
Frequency: 1 affected / 39 at risk

Adverse event: Prolonged hospital stay
Serious: yes
Organ System: Surgical and medical procedures
Notes: Prolongation of existing hospitalization
Frequency: 1 affected / 39 at risk

Adverse event: Pulmonary complications
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Brochopleural fistula, empyema, or pneumonia
Frequency: 2 affected / 39 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Acute myocardial infarction diagnosis during the study period
Frequency: 1 affected / 39 at risk
Study: NCT02178566

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Patient reported jittery feeling and lightheadedness
Frequency: 1 affected / 1 at risk
Study: NCT02178787

Adverse event: Headband pressure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 30 at risk

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

Adverse event: Headband pressure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk
Study: NCT02178995

Adverse event: Increased anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: One participant reported increased anxiety after having tolerated all of the blinded capsules in the randomized portion. This participant elected to withdraw from the open- label portion.
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: One participant tolerated all three randomized doses, yet experienced fatigue on the open-label dose. This participant elected to withdraw from the open-label trial.
Frequency: 1 affected / 30 at risk

Adverse event: Anxiety/panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Four participants experienced a period of anxiety following ingestion of medication, lasting 1-3 hours, without other symptoms. Vitals were stable, and symptoms resolved on their own. Two of the four elected to withdraw.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety/panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Four participants experienced a period of anxiety following ingestion of medication, lasting 1-3 hours, without other symptoms. Vitals were stable, and symptoms resolved on their own. Two of the four elected to withdraw.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety/panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Four participants experienced a period of anxiety following ingestion of medication, lasting 1-3 hours, without other symptoms. Vitals were stable, and symptoms resolved on their own. Two of the four elected to withdraw.
Frequency: 2 affected / 6 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: \~4 hours after dose had 2-3 hours of HR \~160bpm w/ no other symptoms. Resolved w/ no intervention. No other symptoms. BP stable per pt report. Pt did not seek care. We withdrew pt.
Frequency: 1 affected / 1 at risk
Study: NCT02179177

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 8 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 8 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02179749

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 49 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope episode while riding a horse resulting in a fall. Overnight hospitalization required.
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk
Study: NCT02179788

Adverse event: Nausea, vomiting diarrhea-Mom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: gas/bloating/cramping-mom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Headache-mom
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: gas/diarrhea/constipation/reflux-infant
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: insufficient weight gain-infant
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Runny nose/cold-infant
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Irritable/other-infant
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: mom-hyperlipidemia and hypertriglyceridemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: mom-emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Infant-fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nausea, vomiting diarrhea-Mom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Mom-Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: gas/diarrhea/constipation/reflux-infant
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Irritable/other-infant
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: mom-uterine cramping and pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Infant-fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT02179853

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Coronary artery aneurysm
Serious: no
Organ System: Cardiac disorders
Notes: 3 patients had increased CAA
Frequency: 1 affected / 3 at risk

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

Adverse event: Coronary artery aneurysm
Serious: no
Organ System: Cardiac disorders
Notes: 3 patients had increased CAA
Frequency: 2 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT02180230

Adverse event: Implant mobile
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 38 at risk

Adverse event: Implant Out
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 38 at risk

Adverse event: Prosthesis retaining screw fracture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Prosthesis retaining screw loosening
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 38 at risk

Adverse event: Hyperplasia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Moving quick temporary abutment
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Bridge loosening
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Phoenetic difficulties
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk
Study: NCT02180438

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: stroke
Frequency: 1 affected / 30 at risk
Study: NCT02180659

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Abortion - Spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 89 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 89 at risk

Adverse event: Pediatric exposure to treatment
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 89 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk
Study: NCT02180672

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 86 at risk

Adverse event: Lower Respiratory Tract (Including Asthma)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 86 at risk

Adverse event: Upper Respiratory Tract (including cough)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 86 at risk

Adverse event: Gastrointestinal Tract
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 86 at risk

Adverse event: Other Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 86 at risk

Adverse event: Sleep Apnea Exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 86 at risk

Adverse event: Other Illness
Serious: no
Organ System: General disorders
Frequency: 31 affected / 86 at risk

Adverse event: Lower Respiratory Tract (Including Asthma)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Upper Respiratory Tract (including cough)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 36 at risk

Adverse event: Gastrointestinal Tract
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Other Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Other Illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk
Study: NCT02180828

Adverse event: Systemic
Serious: no
Organ System: Cardiac disorders
Notes: Systemic: weak, palpitation, tachycardia, migraine,headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Frequency: 1 affected / 115 at risk

Adverse event: Vulvovaginal
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vulvovaginal pruritus, burning, irritation, and bleeding
Frequency: 12 affected / 115 at risk

Adverse event: Systemic
Serious: no
Organ System: Cardiac disorders
Notes: Systemic: weak, palpitation, tachycardia, migraine,headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Frequency: 9 affected / 113 at risk

Adverse event: Vulvovaginal
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vulvovaginal pruritus, burning, irritation, and bleeding
Frequency: 1 affected / 113 at risk
Study: NCT02181400

Adverse event: Unrelated to study treatment systemic adverse events
Serious: no
Organ System: General disorders
Notes: see AE table if needed
Frequency: 7 affected / 7 at risk

Adverse event: Unrelated to study treatment systemic adverse events
Serious: no
Organ System: General disorders
Notes: see AE table if needed
Frequency: 4 affected / 7 at risk

Adverse event: Unrelated to study treatment systemic adverse events
Serious: no
Organ System: General disorders
Notes: see AE table if needed
Frequency: 6 affected / 7 at risk
Study: NCT02181517

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Retinal vein occlusion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vitritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye 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: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

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

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk
Study: NCT02181530

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 43 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 43 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 43 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 43 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 43 at risk

Adverse event: Cortical/nuclear cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 43 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 43 at risk
Study: NCT02181556

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Large intestine perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Venous TE disorders
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 40 at risk
Study: NCT02181621

Adverse event: Spinal Infection
Serious: yes
Organ System: General disorders
Notes: Not related to study or investigational product; resulted in study withdrawal.
Frequency: 1 affected / 9 at risk

Adverse event: Foot Laceration
Serious: no
Organ System: General disorders
Notes: Patient visited emergency room due to having stepped on glass; not study or investigational product related.
Frequency: 1 affected / 9 at risk

Adverse event: Right Foot Abscess with Osteomyelitis
Serious: yes
Organ System: General disorders
Notes: Right foot abscess with osteomyelitis; right proximal phalanx and metatarsal head resection with washout and primary closure; not related to study or investigational product; resulted in study withdrawal.
Frequency: 1 affected / 10 at risk

Adverse event: Open Ulcer, Left Great Toe
Serious: no
Organ System: General disorders
Notes: Open ulcer (non-target ulcer) on left great toe which was not present one week prior; not related to study or investigational product.
Frequency: 1 affected / 10 at risk