TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02157519

Adverse event: Adherence data of one study participant was lost in the mail
Serious: no
Organ System: Product Issues
Notes: A patient's de-identified Medication Event Monitoring System (MEMS) pill bottle was lost in the mail. There was no breach of confidentiality.
Frequency: 1 affected / 91 at risk
Study: NCT02157779

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Panic Attack
Frequency: 2 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac attack
Frequency: 1 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: Psychiatric disorders
Notes: Veteran accidentally overdosed on cocaine and fentanyl
Frequency: 1 affected / 45 at risk
Study: NCT02158039

Adverse event: Acute interstitial pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Required hospitalization
Frequency: 1 affected / 23 at risk

Adverse event: Death due to pancreatic adenocarcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death due to metastatic gallbladder carcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death due to congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death due to biventricular systolic heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death due to motor vehicle accident
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 23 at risk

Adverse event: Transient abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT02158052

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Transient acute kidney injury due to tacrolimus and engraftment syndrome
Frequency: 1 affected / 1 at risk

Adverse event: Hematopoietic graft rejection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Delayed (secondary) hematopoietic graft rejection. A second HLA-matched related stem cell transplant was performed from the same donor on 5/11/16 with successful and sustained engraftment.
Frequency: 1 affected / 1 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary aspergillosis following hematopoietic graft rejection, treated to resolution following a second hematopoietic cell transplant from the same donor and anti-fungal therapy
Frequency: 1 affected / 1 at risk

Adverse event: Perinephric hematoma
Serious: no
Organ System: Renal and urinary disorders
Notes: A postoperative transient perinephric hematoma occurred, not requiring surgical intervention.
Frequency: 1 affected / 1 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain due to constipation occurred which was alleviated by a bowel regimen.
Frequency: 1 affected / 1 at risk
Study: NCT02158273

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk
Study: NCT02158364

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3225 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3225 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 214 affected / 3225 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 162 affected / 3225 at risk
Study: NCT02158442

Adverse event: MCA Infarct
Serious: yes
Organ System: Cardiac disorders
Notes: R MCA Infarct on control subject
Frequency: 1 affected / 7 at risk
Study: NCT02158585

Adverse event: Gastrointestinal problem
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT02158663

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization due to worsening depression.
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 17 at risk

Adverse event: numbing sensation of scalp
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: tenderness of head from TMS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: psychiatric hospitalization
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization due to worsening depression.
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 18 at risk

Adverse event: psychiatric hospitalization
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: trouble concentrating at work
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk
Study: NCT02159040

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: cardiac arrest
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Infusion site
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02159183

Adverse event: Kneeoperation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tooth related events
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Implant related events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 22 at risk

Adverse event: Prosthetic related events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 22 at risk

Adverse event: Non-related clinical conditions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ablation of a cyste in the femur
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient died of heart attack
Frequency: 1 affected / 21 at risk

Adverse event: Tooth related events
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Implant related events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 21 at risk

Adverse event: Prosthetic related events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 21 at risk

Adverse event: Non-related clinical conditions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk
Study: NCT02159482

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

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

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.
Frequency: 2 affected / 6 at risk

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

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.
Frequency: 1 affected / 6 at risk

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

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 6 at risk

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

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT02159729

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 140 at risk

Adverse event: Asymptomatic cystic thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 140 at risk

Adverse event: Third degree heart block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 140 at risk

Adverse event: Patient died of pancreatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 65 at risk
Study: NCT02159807

Adverse event: vasovagal response
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk
Study: NCT02159859

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Muscle jerking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rusty urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk
Study: NCT02159950

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk
Study: NCT02160002

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Moderate cold stress
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 187 at risk

Adverse event: Severe cold stress
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 187 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 187 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: NEC IIa
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Tachycardia with desaturations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 187 at risk

Adverse event: Increasing heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 187 at risk

Adverse event: Moderate cold stress
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 179 at risk

Adverse event: Severe cold stress
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 179 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 179 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Desaturations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk
Study: NCT02160314

Adverse event: Candida test positive
Serious: no
Organ System: Investigations
Frequency: 4 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 72 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: this adverse event corresponds to vaginal spotting in 3 subjects, and vaginal bleeding in 1 subject
Frequency: 4 affected / 72 at risk
Study: NCT02160535

Adverse event: Increased Headache
Serious: no
Organ System: General disorders
Notes: One subject experienced increased headache after treatment. Event thought to be local effect from injection sites and subject's sensitization to repetitive needle sticks.
Frequency: 1 affected / 13 at risk
Study: NCT02160730

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Elevated Creatinine Levels
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk
Study: NCT02160873

Adverse event: Reduced sleep quality
Serious: no
Organ System: General disorders
Notes: Subjects reported altered sleep quality and/or duration following intervention.
Frequency: 4 affected / 12 at risk
Study: NCT02161146

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 47 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT02161185

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk
Study: NCT02161380

Adverse event: Visual Acuity Loss
Serious: yes
Organ System: Eye disorders
Notes: SAE will be considered a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
Frequency: 1 affected / 9 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Notes: One participant of Low Dose had two different episodes of Uveitis
Frequency: 1 affected / 9 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Notes: Causality: not related to research. One participant of Higher dose had 2 different adverse events: Corneal abrasion and Uveitis.
Frequency: 1 affected / 9 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: causality: not related to research
Frequency: 1 affected / 9 at risk

Adverse event: Visual Acuity Loss
Serious: yes
Organ System: Eye disorders
Notes: SAE will be considered a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
Frequency: 1 affected / 9 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Notes: One participant of Low Dose had two different episodes of Uveitis
Frequency: 1 affected / 9 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: causality: not related to research
Frequency: 2 affected / 9 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Notes: One participant of Low Dose had two different episodes of Uveitis
Frequency: 1 affected / 3 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Notes: One participant of Low Dose had two different episodes of Uveitis
Frequency: 5 affected / 7 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Notes: Causality: not related to research. One participant of Higher dose had 2 different adverse events: Corneal abrasion and Uveitis.
Frequency: 1 affected / 7 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: causality: not related to research
Frequency: 1 affected / 7 at risk
Study: NCT02161536

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The head design comprises flexible balcony-like in the tip which was beyond the scope's field of view, are suspected as the cause for the perforation.

The event was resolved with a scar as a residual effect.
Frequency: 1 affected / 6 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild laceration resolved with no clinical sequelae within two days
Frequency: 2 affected / 6 at risk

Adverse event: Erosion
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild erosion resolved with no clinical sequelae
Frequency: 2 affected / 6 at risk

Adverse event: Submucosal Hematoma
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild Hematoma resolved with no clinical sequelae
Frequency: 2 affected / 6 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild laceration resolved with no clinical sequelae within two days
Frequency: 1 affected / 21 at risk

Adverse event: Submucosal Hematoma
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild Hematoma resolved with no clinical sequelae
Frequency: 1 affected / 21 at risk