Genecept Assay™ vs. Treatment-as-Usual to Evaluate Effica... | NCT02634177

NCT02634177

Status Module

Sponsor/Collaborators Module

Name	Class
Medpace, Inc.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Assay-guided treatment (AGT)	Active Comparator	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.	Genetic: Assay-guided treatment (AGT)
Treatment-as-usual (TAU)	Placebo Comparator	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.	Other: Treatment-as-usual (TAU)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assay-guided treatment (AGT)	Genetic	The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.	SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.	Baseline to 8 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.	QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.	Baseline to 8 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75 years; Sub-Group Age =/> 65 years
Ability to understand and provide informed consent
Ability to understand, read and speak English
Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0
SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline
Failure of at least 1 prior adequate trial of standard antidepressant in the current major depressive episode (using ATRQ criteria - i.e., 6 weeks at adequate dose) due to inefficacy, side effects or intolerability
Subject is willing to follow study instructions, complete study assessments and likely to complete all required visits

Exclusion Criteria:

Severe personality traits (based on DSM-5 criteria) that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety and all diagnosed Personality Disorders
Current DSM-5 diagnosis of Neurocognitive Disorders, Schizophrenia Spectrum (lifetime diagnosis) and other Psychotic Disorders, Bipolar and Related disorders (lifetime diagnosis*), Trauma and Stress related Disorders, Obsessive Compulsive Disorder and Related Disorders. Other DSM-5 disorders that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety.
DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)
History of Suicidal Behavior within 12 months of screening or presence of Active Suicidal Ideation with Intent in the past 12 months (Items 4 or 5) at Screening or Baseline, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), or subject is considered to be an acute suicide risk in the clinical judgment of the investigator
Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator
Four (4) or more failed pharmacologic interventions for depression in the current major depressive episode (One of the four failed interventions must meet ATRQ criteria - i.e., 6 weeks at adequate dose).
Subjects who are not willing to take psychotropic medications for treatment of MDD.
Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) started within 90 days of screening or planned during the study.
Subjects with a vagus nerve or deep brain stimulator are prohibited from the trial.
Psychotherapy including cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) started within 90 days of screening or planned during the study.
Unstable or active medical condition(s) which in the opinion of the investigator would jeopardize the subject's safety or interfere with participation of the study or confound evaluation of efficacy or safety.
Current diagnosis of unstable hypothyroidism.
Females who are pregnant, nursing, or planning a pregnancy during the study or believe they may be pregnant at Screening or Baseline.
Participation in another investigative trial within 30 days of screening
Subject previously treated with the use of a similar psychotropic genetic testing assay.
Subject tests positive for illicit drug use on the urine drug screen (UDS) at the screen visit (including Marijuana where legal).

Contacts/Locations Module

Name	Affiliation	Role
David Krause, MD	Genomind CMO	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham		Birmingham	Alabama	35294	United States
Noesis Pharma

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jun 30, 2017	Sep 13, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Assay-guided treatment (AGT)

The baseline analysis was completed on the all randomized set as defined in the SAP. All data may not have been available for every endpoint for each patient included in the baseline analysis population. Therefore the number of patients at baseline and the number completed may not match specific endpoints.

Arm/Group Information

ID	Title	Description
BG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
BG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00047.8± 12.38 BG00147.6± 12.03 BG00247.7± 12.20

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000107 BG001111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000151 BG001153 BG002

Body Weight (kg) at Screening

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00088.59± 22.338 BG00189.28± 24.787 BG002

Height at Screening

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000168.3± 10.64 BG001168.0± 9.41 BG002

BMI at Screening

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00031.27± 7.491 BG00131.62± 8.443 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.

SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale

Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.

Posted

Mean

Standard Deviation

units on a scale

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts
Participants	OG000138 OG001140

Title

Denominators

Categories

Title	Measurements
	OG000-9.70± 6.411 OG001-10.16± 6.689

Secondary

Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.

QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report

QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.

Posted

Mean

Standard Deviation

units on a scale

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts
Participants

Secondary

Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.

SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale

Posted

Count of Participants

Participants

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts
Participants

Secondary

Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.

QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report

Posted

Count of Participants

Participants

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts

Secondary

Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.

CGI-I: Clinical Global Impression Improvement scale; a clinician-rated scale that measures the improvement or worsening of a patient's symptoms

The CGI-I is rated on a 7-point scale, with the improvement in severity of illness scale using a range of responses from 1 (Very much improved) through to 7 (Very much worse).

A score of 0 indicates Patient was not able to be assessed

Posted

Count of Participants

Participants

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts

Secondary

Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.

SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale

Posted

Count of Participants

Participants

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts

Secondary

Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16.

QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report

Posted

Count of Participants

Participants

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Units	Counts
Participants

Secondary

Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER).

A 3-question patient-rated scale for assessing frequency, intensity, and burden of medication side effects for patients receiving treatment for depression.

The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale.

A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s).

Posted

Mean

Standard Deviation

units on a scale

Baseline to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Secondary

Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.

Untoward medical occurrence in a subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with treatment.

As based on FIBSER

The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale.

Posted

Mean

Standard Deviation

score on a scale

Screening to 8 Weeks

ID	Title	Description
OG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
OG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Assay-guided Treatment (AGT)	Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.	0	150	6	150	107	150
EG001	Treatment-as-usual (TAU)	The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.	0	153	3	153	111	153

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected153 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Streptococcal sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Multiple sclerosis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Systematic Assessment	EG00022 events22 affected150 at risk EG00115 events15 affected153 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG00013 events13 affected150 at risk EG00119 events19 affected153 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG00110 events10 affected153 at risk
Sedation	Nervous system disorders	Systematic Assessment	EG0007 events7 affected150 at risk EG0014 events4 affected153 at risk
Coordination abnormal	Nervous system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0016 events6 affected153 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0016 events6 affected153 at risk
Dizziness postural	Nervous system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0012 events2 affected153 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0012 events2 affected153 at risk
Hypersomnia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Tension headache	Nervous system disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0010 events0 affected153 at risk
Disturbance in attention	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Restless legs syndrome	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Amnesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Complex regional pain syndrome	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Mental impairment	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Migraine	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Narcolepsy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Parosmia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Psychomotor hyperactivity	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Trigeminal neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG00022 events22 affected150 at risk EG00115 events15 affected153 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00015 events15 affected150 at risk EG00117 events17 affected153 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00011 events11 affected150 at risk EG00114 events14 affected153 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00013 events13 affected150 at risk EG0017 events7 affected153 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0013 events3 affected153 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected153 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0012 events2 affected153 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected153 at risk
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0010 events0 affected153 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Feces discoloured	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Feces soft	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Large intestinal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Uvulitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00010 events10 affected150 at risk EG0019 events9 affected153 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0009 events9 affected150 at risk EG0017 events7 affected153 at risk
Irritability	Psychiatric disorders	Systematic Assessment	EG0006 events6 affected150 at risk EG00110 events10 affected153 at risk
Libido decreased	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0019 events9 affected153 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0012 events2 affected153 at risk
Abnormal dreams	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0014 events4 affected153 at risk
Bruxism	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected153 at risk
Sleep disorder	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0012 events2 affected153 at risk
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected153 at risk
Anorgasmia	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Nightmare	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Middle insomnia	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected153 at risk
Orgasm abnormal	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Anger	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Derealisation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Disorientation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Hallucination, visual	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Nervousness	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Panic attack	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0007 events7 affected150 at risk EG0014 events4 affected153 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected150 at risk EG0014 events4 affected153 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected153 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Viral infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected153 at risk
Bacterial vaginosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Ear infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Laryngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Papilloma viral infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Tinea pedis	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Tooth infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Vulvovaginal mycotic infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00011 events11 affected150 at risk EG0017 events7 affected153 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0015 events5 affected153 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0013 events3 affected153 at risk
Pruritus	Infections and infestations	Systematic Assessment	EG0003 events3 affected150 at risk EG0013 events3 affected153 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected153 at risk
Psoriasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Rash macular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Fatigue	General disorders	Systematic Assessment	EG0006 events6 affected150 at risk EG0014 events4 affected153 at risk
Chest pain	General disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected153 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Edema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Chest discomfort	General disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Crying	General disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Drug withdrawal syndrome	General disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Feeling hot	General disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Increased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0007 events7 affected150 at risk EG0015 events5 affected153 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0015 events5 affected153 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0014 events4 affected153 at risk
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0011 events1 affected153 at risk
Urinary hesitation	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Micturition frequency decreased	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Micturition urgency	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected153 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0014 events4 affected153 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0013 events3 affected153 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Coronary artery dilatation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Coronary ostial stenosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0017 events7 affected153 at risk
Dry eye	Eye disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Blepharitis	Eye disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Blepharospasm	Eye disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Eye pruritus	Eye disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Periorbital edema	Eye disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0013 events3 affected153 at risk
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Hot flush	Vascular disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected153 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected153 at risk
Flushing	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Hypertensive crisis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Joint injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected153 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Heat stroke	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Muscle strain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected153 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Microcytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected153 at risk
Menstruation irregular	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Nocturnal emission	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected153 at risk
Seasonal allergy	Immune system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
Weight increased	Investigations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected153 at risk
White blood cell count increased	Investigations	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk
Adrenal mass	Endocrine disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected153 at risk

ID	Term
D003865	Depressive Disorder, Major

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders