TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02895464

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Joint pain
Frequency: 2 affected / 10 at risk
Study: NCT02895945

Adverse event: Anamnestic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Anti factor VIII antibody increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Anti factor VIII antibody positive
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

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

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

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk
Study: NCT02896257

Adverse event: Inpatient COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalized for COPD exacerbation within the 180 days after the index date.
Frequency: 6 affected / 281 at risk

Adverse event: Outpatient COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Experienced an outpatient COPD exacerbation within the 180 days after the index date.
Frequency: 30 affected / 281 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Experienced either an inpatient or outpatient pneumonia event within 180 days after the index date.
Frequency: 8 affected / 281 at risk

Adverse event: Inpatient COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalized for COPD exacerbation within the 180 days after the index date.
Frequency: 7 affected / 269 at risk

Adverse event: Outpatient COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Experienced an outpatient COPD exacerbation within the 180 days after the index date.
Frequency: 23 affected / 269 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Experienced either an inpatient or outpatient pneumonia event within 180 days after the index date.
Frequency: 5 affected / 269 at risk
Study: NCT02896296

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 208 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 208 at risk
Study: NCT02896361

Adverse event: Bilateral ISG syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One subject reported an adverse event 35 days after randomization to Group 2. The subject developed a new pain condition, bilateral ISG syndrome after enrollment.
Frequency: 1 affected / 26 at risk
Study: NCT02896907

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk
Study: NCT02897531

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 65 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk
Study: NCT02898116

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system 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

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

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition 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: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
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: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT02898597

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: The patient had a stroke and then diseased from kidney failure. The adverse event was not study-related.
Frequency: 1 affected / 24 at risk
Study: NCT02898662

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Trigger finger
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pulmonary eosinophilia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk
Study: NCT02899000

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 175 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 175 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 175 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 175 at risk
Study: NCT02899377

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT02899689

Adverse event: Serious Adverse event
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin breakdown from mobility due to epidural. Unrelated to the study since device was already removed and epidural placed after the intervention (Foley balloon ) was removed. Occurred in the postpartum period
Frequency: 1 affected / 209 at risk

Adverse event: Motor vehicle collision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 motor vehicle accident - occurred postpartum within 2 weeks of delivery. Resulted in prolonged hospitalization
Frequency: 1 affected / 209 at risk
Study: NCT02900092

Adverse event: Sleepiness and fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk
Study: NCT02901067

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gastro-intestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PE diagnosed 5 days after transfer out of the ICU, thus no impact on administration of study drug.
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient was diagnosed with PE on hospital day 2 and study drug discontinued per protocol.
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PE diagnosed after transfer out of the ICU, thus no impact on administration of study drug.
Frequency: 1 affected / 18 at risk
Study: NCT02901080

Adverse event: Headache and insomnia
Serious: no
Organ System: Product Issues
Notes: Headache and insomnia are known possibilities of CES if the current is set too high for the participant to used too close to bedtime.
Frequency: 2 affected / 161 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea is a known possibility of CES treatment if the current is set too high for the participants
Frequency: 1 affected / 161 at risk

Adverse event: Strange feeling after use
Serious: no
Organ System: General disorders
Notes: Participant was nonspecific regarding the event.
Frequency: 1 affected / 161 at risk
Study: NCT02901574

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Application site tingling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

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

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 24 at risk

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

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk
Study: NCT02902146

Adverse event: Cardiac arrest in the ED at any time
Serious: yes
Organ System: Cardiac disorders
Notes: All were unrelated to study participation
Frequency: 12 affected / 381 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen saturation less than 90 % during or within 1 minute of intubation completion.

This outcome only includes participants on whom we were able to record an oxygen saturation during intubation. Therefore, it is less than the total.
Frequency: 47 affected / 371 at risk

Adverse event: Cardiac arrest in the ED at any time
Serious: yes
Organ System: Cardiac disorders
Notes: All were unrelated to study participation
Frequency: 11 affected / 376 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen saturation less than 90 % during or within 1 minute of intubation completion.

This outcome only includes participants on whom we were able to record an oxygen saturation during intubation. Therefore, it is less than the total.
Frequency: 50 affected / 374 at risk
Study: NCT02903030

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distension (S:1, P:1)\*\* Abdominal pain (S:1 P:2) Diarrhoea (S:0 P:2) Flatulence (S:3 P:2) Nausea (S:1 P:2) Vomiting (S:1 P:0)

\*\* S= Supplement/Probiotic P = Placebo number is events reported
Frequency: 6 affected / 10 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distension (S:1, P:1)\*\* Abdominal pain (S:1 P:2) Diarrhoea (S:0 P:2) Flatulence (S:3 P:2) Nausea (S:1 P:2) Vomiting (S:1 P:0)

\*\* S= Supplement/Probiotic P = Placebo number is events reported
Frequency: 4 affected / 10 at risk
Study: NCT02903121

Adverse event: Cramping, changes in menstrual fluid
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 55 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 55 at risk

Adverse event: Headache, migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 55 at risk

Adverse event: Hot flush
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 55 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 55 at risk

Adverse event: Nausea, Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Weakness, fatigue, dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 55 at risk

Adverse event: Yeast infection, bacterial vaginosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 55 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache, migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hot flush
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 52 at risk

Adverse event: Nausea, Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Weakness, fatigue, dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 52 at risk
Study: NCT02903355

Adverse event: Abdominal Pain/Cramps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 159 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 159 at risk

Adverse event: Flatulence
Serious: no
Organ System: Product Issues
Frequency: 56 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 159 at risk

Adverse event: Nausea/ Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Urine Odor
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 159 at risk

Adverse event: Abdominal Pain/Cramps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 157 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Product Issues
Frequency: 35 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 157 at risk

Adverse event: Flatulence
Serious: no
Organ System: Product Issues
Frequency: 52 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 157 at risk

Adverse event: Nausea/ Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 157 at risk

Adverse event: Urine Odor
Serious: no
Organ System: Product Issues
Frequency: 66 affected / 157 at risk
Study: NCT02903446

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastro-esophageal reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Esophageal refulx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk
Study: NCT02903511

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Light-headedness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Viral Illness
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 26 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Abdominal cramping/pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Light-headedness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Viral Illness
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 25 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Abdominal cramping/pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk
Study: NCT02903823

Adverse event: Catheter dislodgement
Serious: no
Organ System: Nervous system disorders
Notes: catheter dislodged from location during manipulation in middle of study
Frequency: 1 affected / 27 at risk