Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic Stimulation (rTMS) helps people with depression who have not been helped by medications or who have not been helped enough by medications.
Major depression occurs in about 10% of American outpatients every year and of those, approximately 20% respond incompletely or not at all to trials of antidepressants, mood stabilizers, or psychotherapy (Kaplan and Sadock, 1996; Keller et al 1992; Thase, 2004). Treatment as usual for these cases of treatment resistant major depression (TRMD) frequently involves increased risks and increased side effects, such as those seen in monoamine oxidase inhibitors (MAOIs) and electroconvulsive therapy (ECT). New TRMD treatments are needed, preferably without major safety concerns or side effects as seen with aggressive polypharmacy or ECT.
Repetitive transcranial magnetic stimulation (rTMS) is a method of delivering brain stimulation without the seizures or risks associated with ECT, nor the potential side effects and risks of MAOI therapy. Systematic review and meta-analysis of the studies to date, which are typically of a small scale, appear to show a positive effect in TRMD (Martin et al. 2003). With a minimal side effect profile, and the rarity of untoward events and side-effects (Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS are considerably less than with ECT. Given this, rTMS has the potential to be a significant advance in care, if it were shown to be effective in TRMD in VA patients.
The trials of rTMS performed to date have not included participants with comorbid disorders, such as substance abuse and post-traumatic stress disorder (PTSD), thus the generalizability of their findings to a VA population is not clear. Further research including Veterans with possible comorbid disorders is necessary, given the high rates of co-occurring substance abuse and PTSD that is present in the Veteran population.
The present study is a randomized, controlled trial that compares active rTMS to a sham condition in Veterans with treatment resistant major depression and possible comorbid post-traumatic stress disorder (PTSD) and / or a history of substance abuse. Veterans will remain under the care of their VA primary mental health provider throughout the project. Participants will be assessed at pre-, mid- and several post-treatment time points. This is a multisite trial that will be conducted at 9 VA Medical Centers around the country.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. |
|
| Sham rTMS | Placebo Comparator | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Repetitive Transcranial Magnetic Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression | The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome. | End of acute treatment 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) | To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome. |
Not provided
Inclusion Criteria:
Between 18 and 80 years of age
Using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) for DSM-IV-TR (First et al. 2002) patients will be diagnosed Major Depressive Disorder (MDD).
Have a Hamilton Rating Scale for Depression (HRSD-24) score greater or equal to 20 no more than 7 days prior to randomization.
Exhibit moderate level of resistance to antidepressant treatment defined, using the Antidepressant Treatment History Form (ATHF) (Sackeim et al. 1990), as failure of at least two adequate medication trials.
Duration of current episode of less than or equal to 10 years.
Ability to obtain a Motor Threshold (MT) (should be determined at the end of the screening process).
Currently under the care of a VA psychiatrist.
If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to randomization and patient will be willing to remain on a stable regimen during the acute treatment phase.
Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
For female participants, agrees to use one of the following acceptable methods of birth control
Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jerome A. Yesavage, MD | VA Palo Alto Health Care System, Palo Alto, CA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| San Francisco VA Medical Center, San Francisco, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28865495 | Background | Mi Z, Biswas K, Fairchild JK, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Georgette G, Beale T, Pittman D, McNerney MW, Rosen A, Huang GD, George M, Noda A, Yesavage JA. Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 2;18(1):409. doi: 10.1186/s13063-017-2125-y. | |
| 29955803 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation |
| FG001 | Sham rTMS | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation |
| BG001 | Sham rTMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression | The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome. | ITT | Posted | Count of Participants | Participants | End of acute treatment 4-6 weeks |
|
From informed consent until termination. 7-8 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerome Yesavage, MD | Director, VISN21 MIRECC, Department of Veterans Affairs | 650-852-3287 | Jerome.Yesavage@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2016 | Jan 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2017 | Jan 4, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D003866 | Depressive Disorder |
| D040921 | Stress Disorders, Traumatic |
| D019966 | Substance-Related Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068099 | Trauma and Stressor Related Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Device |
| Device |
Placebo Device that simulates active rTMS treatment |
|
| End of acute treatment 4-6 weeks, then end of F/U 6 months |
| Mean Depression Score as Assessed by Beck Depression Inventory (BDI) | This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state. | Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months |
| Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. | End of acute treatment 4-6 weeks, then end of F/U 6 months |
| Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. | End of acute treatment 4-6 weeks, then end of F/U 6 months |
| Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) | As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome. | End of acute treatment 4-6 weeks, then end of F/U 6 months |
| San Francisco |
| California |
| 94121 |
| United States |
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | United States |
| Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | 76504 | United States |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | 05009-0001 | United States |
| Derived |
| Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS; VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483. |
Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Beck Scale for Suicide Ideation (BSI) | This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome. | Missing values | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory (BDI) | This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. | Missing values | Mean | Standard Deviation | units on a scale |
|
| VR-36 Mental Component Summary (MCS) | Standardized scoring ranging from 0-100. A higher score represents a better outcome | Missing value | Mean | Standard Deviation | units on a scale |
|
| VR-36 Physical Component Summary (PCS) | Standardized scoring ranging from 0-100. A higher score represents a better outcome | Missing value | Mean | Standard Deviation | units on a scale |
|
| Montgomery Asberg Depression Rating Scale (MADRS) | As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). | Mean | Standard Deviation | units on a scale |
|
Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
|
|
| Secondary | Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) | To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome. | ITT minus participants with missing values | Posted | Mean | Standard Deviation | units on a scale | End of acute treatment 4-6 weeks, then end of F/U 6 months |
|
|
|
| Secondary | Mean Depression Score as Assessed by Beck Depression Inventory (BDI) | This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state. | ITT minus participants with missing values | Posted | Mean | Standard Deviation | units on a scale | Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months |
|
|
|
| Secondary | Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. | ITT minus participants with missing values | Posted | Mean | Standard Deviation | units on a scale | End of acute treatment 4-6 weeks, then end of F/U 6 months |
|
|
|
| Secondary | Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. | ITT minus participants with missing values | Posted | Mean | Standard Deviation | units on a scale | End of acute treatment 4-6 weeks, then end of F/U 6 months |
|
|
|
| Secondary | Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) | As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome. | ITT minus participants with missing values | Posted | Mean | Standard Deviation | units on a scale | End of acute treatment 4-6 weeks, then end of F/U 6 months |
|
|
|
| 0 |
| 81 |
| 22 |
| 81 |
| 71 |
| 81 |
| EG001 | Sham rTMS | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment | 0 | 83 | 18 | 83 | 69 | 83 |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Persistent depressive disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acoustic stimulation tests abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hernia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oral bacterial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Vaginitis gardnerella | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mononeuropathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Phantom pain | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest wall mass | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acoustic stimulation tests abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Animal scratch | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Ear canal abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Incorrect dosage administered | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Penis injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Agitated depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Derealisation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flashback | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Parasomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nodule | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sensation of blood flow | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Episcleritis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Elective procedure | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Papilloma excision | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D064419 |
| Chemically-Induced Disorders |
| D010549 | Personal Satisfaction |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|