Study: NCT02653664

Adverse event: New/Unusual/ Worsening Pain or Physical Discomfort At Least Possibly Related to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Medically Important Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 110 at risk

Adverse event: New Cancer Diagnosis, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Seizures, Unrelated to Study Procedures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 9 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Nausea, At Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Adverse Medication Reaction, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New Illness/Infection/Untoward Medical Occurrence Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 35 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Fatigue, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Headache/Migraine, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 10 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 23 affected / 110 at risk

Adverse event: New/Worsening Psych. Discomfort At Least Possibly Related to Baseline Hypnotizability Assessment
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New/Worsening Psychological Discomfort At Least Possibly Related to Study Procedures, General
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Self-Report Measures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: New/Worsening Skin Irritation, At Least Possibly Related to Wearing Sleep Sub-Study Actigraph Device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Sleep Problems Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New/Worsening Pain, Phys. Discomfort at Least Possibly Related to Baseline Hypno. Assessment
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 8 affected / 110 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Non-Life Threatening Suicidal Ideation, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Non-Life Threatening/ Outpatient Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 22 affected / 110 at risk

Adverse event: Medically Important Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 110 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 110 at risk

Adverse event: Homicidal Ideation, Unrelated to Study Procedures
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 13 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Nausea, At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Adverse Medication Reaction, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New Diagnosis, Not Life Threatening, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New Illness/Infection/Untoward Medical Occurrence Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 31 affected / 110 at risk

Adverse event: New Illness/Infection/Untoward Medical Occurrence, At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Cognitive Difficulties, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Fatigue, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 4 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/ Worsening Headache/Migraine, At Least Possibly Related to Baseline Hypnotizability Assessment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Headache/Migraine, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 10 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 21 affected / 110 at risk

Adverse event: New/Worsening Psych. Discomfort At Least Possibly Related to Baseline Hypnotizability Assessment
Serious: no
Organ System: General disorders
Frequency: 4 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 6 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Self-Report Measures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 12 affected / 110 at risk

Adverse event: New/Worsening Skin Irritation, At Least Possibly Related to Wearing Sleep Sub-Study Actigraph Device
Serious: no
Organ System: General disorders
Frequency: 5 affected / 110 at risk

Adverse event: New/Unusual/ Worsening Sleep Problems Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 5 affected / 110 at risk

Adverse event: New/Worsening Pain, Phys. Discomfort at Least Possibly Related to Baseline Hypno. Assessment
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Consent Session
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: Non-Life Threatening/ Outpatient Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 14 affected / 110 at risk

Adverse event: Medically Important Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 108 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 108 at risk

Adverse event: Life Threatening Suicidal Ideation/Attempt, Unrelated to Study Procedures
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 108 at risk

Adverse event: Inpatient Hospitalization, Unrelated to Study Procedures
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: New Physical Injury, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 15 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Nausea, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Adverse Medication Reaction, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: New Diagnosis, Not Life Threatening, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New Illness/Infection/Untoward Medical Occurrence Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 28 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Cognitive Difficulties, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Fatigue, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to Study Self-Report Measures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Headache/Migraine, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 5 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 23 affected / 108 at risk

Adverse event: New/Worsening Psych. Discomfort At Least Possibly Related to Baseline Hypnotizability Assessment
Serious: no
Organ System: General disorders
Frequency: 6 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Self-Report Measures
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Psychological Discomfort, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 11 affected / 108 at risk

Adverse event: New/Worsening Skin Irritation, At Least Possibly Related to Wearing Sleep Sub-Study Actigraph Device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Sleep Sub-Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New/Unusual/ Worsening Sleep Problems Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: New/Worsening Pain, Phys. Discomfort at Least Possibly Related to Baseline Hypno. Assessment
Serious: no
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to EEG Procedures
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Self-Report Measures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Treatment Procedures
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Non-Life Threatening Suicidal Ideation, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Non-Life Threatening/ Outpatient Surgery or Medical Procedure, Unrelated to Study Procedures
Serious: no
Organ System: General disorders
Frequency: 18 affected / 108 at risk