TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02328404

Adverse event: In-compliance , Withdral
Serious: no
Organ System: Social circumstances
Notes: One Volunteer was dropped out due to in-compliance / Not responding to phone call.

One Volunteer had withdrawn due to long term travel outside the country after starting the study
Frequency: 1 affected / 30 at risk

Adverse event: In-compliance , Withdral
Serious: no
Organ System: Social circumstances
Notes: One Volunteer was dropped out due to in-compliance / Not responding to phone call.

One Volunteer had withdrawn due to long term travel outside the country after starting the study
Frequency: 1 affected / 30 at risk
Study: NCT02328547

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Worsening of Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Regurgitation/Emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One study-unrelated SAE was reported. This participant underwent cholecystectomy for acute cholecystitis 2 months after ingesting placebo capsules.
Frequency: 1 affected / 48 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Worsening of Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk
Study: NCT02328755

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: consistent with gouty arthritis
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis (ARDS) (1); Acute Hypoxemia (1)
Frequency: 2 affected / 33 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Liver Function Test elevation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk
Study: NCT02328807

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Other - Blood in semen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 6 at risk

Adverse event: Other - sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Other - prostate sensitivity
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Renal and urinary disorders - Other, nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sinuusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Renal and urinary disorders - Other Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Renal and urinary disorders - Other, Burning sensation while urinating
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk
Study: NCT02329834

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 16 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: BNP elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral pulse decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Total CK elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Troponin elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT02330081

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 22 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: Cold/influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Collapsed vein during donation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vasovagal syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Blisters on both feet
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk
Study: NCT02330094

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Delirium
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT02330276

Adverse event: Intermittent Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Study subject reported having intermittent headaches (most likely due to lack of caffeine). Subject reported that the headaches resolved after taking the ibuprofen.
Frequency: 1 affected / 4 at risk
Study: NCT02330341

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk
Study: NCT02330523

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Healing was "as expected" for both treatment modalities; no AEs occurred that could be attributed to the study, though 1 subject presented with a localized infection with suppuration at the test site (DFDBA+RECXC) and was treated with antibiotics.
Frequency: 1 affected / 21 at risk
Study: NCT02330653

Adverse event: Grade 3 Sinus Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Hypersensitivity reaction from FMT induction enema resulting in sinus tachycardia and an ED admission. Inpatient for 2 days following
Frequency: 1 affected / 12 at risk

Adverse event: Grade 3 Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Increase in symptoms like abdominal pain, blood in stool and or watery stool, high frequency of stooling, nausea/vomiting, and dehydration
Frequency: 2 affected / 12 at risk

Adverse event: Epiploic appendagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE was not related to study intervention.
Frequency: 1 affected / 12 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Immune system disorders
Notes: Decreased WBC, increased bilirubin, increase Alkaline phosphatase, and increased lymphocyte count were all present but were determined to be not related or present at baseline.
Frequency: 2 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever, dizziness, flushing, and chills were reported as probably related and resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Eczema/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Eczema and rash unrelated to the study treatment were reported
Frequency: 2 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sore Throat
Frequency: 1 affected / 12 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Non-Cardiac Chest Pain
Frequency: 2 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper Respiratory Infection
Frequency: 1 affected / 12 at risk

Adverse event: Eye Disorder/Blurred Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever, dizziness, flushing, and chills were reported as probably related and resolved without sequelae
Frequency: 1 affected / 5 at risk

Adverse event: Eczema/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Eczema and rash unrelated to the study treatment were reported
Frequency: 1 affected / 5 at risk

Adverse event: Eye Disorder/Blurred Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk
Study: NCT02330978

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: A combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - treated with vitrectomy and silicone oil tamponade. At the final follow-up period he remained with no retinal detachment and light perception vision.
Frequency: 1 affected / 2 at risk
Study: NCT02331277

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

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

Adverse event: Chest pain
Serious: no
Organ System: General 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: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue 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: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Nasal pruritus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 9 at risk
Study: NCT02331394

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intermittent
Frequency: 5 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

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

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Dermatitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT02331992

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk
Study: NCT02332187

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02332655

Adverse event: Left Eye Vertical Nystagmus
Serious: yes
Organ System: Eye disorders
Notes: Subject reported vertical eye movement in left eye that persisted for several months. Pressures were same as baseline and no change in apparent vision or visual field cut were detected. MRI was conducted and patient was seen for follow up.
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The participant got sick with vomiting and diarrhea. He had a seizure and was noted to have a cough and fever. After having two more seizures, he was taken to the ER where an x-ray determined he had pneumonia and dehydration.
Frequency: 1 affected / 5 at risk

Adverse event: Facial Skin Infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject picked at a facial pimple above her left eye. The area reddened and began to swell. She was taken to the ER and given IV antibiotics.
Frequency: 1 affected / 5 at risk

Adverse event: Temporary increased seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 5 at risk

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

Adverse event: Increased aspartate aminotransferase liver function test
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Right eye exotropia and redness/intermittent exotropia without redness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk
Study: NCT02332824

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 67 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 67 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 74 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 68 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 69 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 70 at risk
Study: NCT02332863

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 22 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk
Study: NCT02332889

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