Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD6765 (150 mg) / Placebo | Experimental | Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. |
|
| Placebo / AZD6765 (150 mg) | Placebo Comparator | Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | Single IV infusion of 150 mg AZD6765. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos A Zarate, MD | National Institute of Mental Health (NIMH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bethesda | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34510411 | Derived | Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3. | |
| 27914292 |
| Label | URL |
|---|---|
| D6702C00015 Clinical Study Report Synopsis | View source |
Not provided
Screening for eligibility and washout of restricted medications.
A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD6765 (150 mg) | Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. |
| FG001 | Placebo | Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD6765 (150 mg)/ Placebo | Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. |
| BG001 |
| 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 | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
Not provided
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 | AZD6765 (150 mg) | Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| C585977 | AZD6765 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo to AZD6765 |
| Drug |
Single IV infusion of Placebo to AZD6765 |
|
| 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Scale for Suicide Ideation (SSI) Total Score. | Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst. | 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
| Visual Analogue Scale (VAS) Depressed Score | The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
| Clinician-Administered Dissociative States Scale (CADSS) Score. | Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
| Brief Psychiatric Rating Scale (BPRS) Score. | The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Beck Depression Inventory (BDI) Score. | Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Young Mania Rating Scale (YMRS) Score. | Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Visual Analogue Scale (VAS) Anxious Score. | The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Brief Psychiatric Rating Scale (BPRS) Positive Score. | Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28. | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
| Lepow L, Luckenbaugh DA, Park L, Henter ID, Zarate CA Jr. Case series: Antidepressant effects of low-affinity and low-trapping NMDA receptor antagonists did not predict response to ketamine in seven subjects. J Psychiatr Res. 2017 Mar;86:55-57. doi: 10.1016/j.jpsychires.2016.10.023. Epub 2016 Nov 22. No abstract available. |
| 23206319 | Derived | Zarate CA Jr, Mathews D, Ibrahim L, Chaves JF, Marquardt C, Ukoh I, Jolkovsky L, Brutsche NE, Smith MA, Luckenbaugh DA. A randomized trial of a low-trapping nonselective N-methyl-D-aspartate channel blocker in major depression. Biol Psychiatry. 2013 Aug 15;74(4):257-64. doi: 10.1016/j.biopsych.2012.10.019. Epub 2012 Dec 1. |
| NOT COMPLETED |
|
| Placebo/AZD6765 (150 mg) |
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. |
|
|
| Secondary | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Number | Participants | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Number | Participants | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Scale for Suicide Ideation (SSI) Total Score. | Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
|
|
|
| Secondary | Visual Analogue Scale (VAS) Depressed Score | The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
|
|
|
| Secondary | Clinician-Administered Dissociative States Scale (CADSS) Score. | Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) Score. | The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Beck Depression Inventory (BDI) Score. | Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Young Mania Rating Scale (YMRS) Score. | Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Visual Analogue Scale (VAS) Anxious Score. | The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. | ITT population including all randomized patients who were given study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28. | Posted | Least Squares Mean | Standard Error | Units on a scale | 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. |
|
|
|
| 0 |
| 22 |
| 21 |
| 22 |
| EG001 | Placebo | Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. | 0 | 20 | 20 | 20 |
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Decreased apetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Increased apetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Thirst | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weight increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Libido increased | Nervous system disorders | Systematic Assessment |
|
| Felt faint | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tic | Psychiatric disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Malignant dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Disturbance in attention | Psychiatric disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | Systematic Assessment |
|
| Somnolence | Psychiatric disorders | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
|
| Irritability | Nervous system disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Hypokinesia | Nervous system disorders | Systematic Assessment |
|
| Psychomotor activity | Psychiatric disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Suicidal behaviour | Nervous system disorders | Systematic Assessment |
|
| Suicidal ideation | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Body temperature decreased | Investigations | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | Systematic Assessment |
|
| Euphoric mood | Nervous system disorders | Systematic Assessment |
|
| Social avoindant behaviour | Psychiatric disorders | Systematic Assessment |
|
| Abnormal behaviour | Nervous system disorders | Systematic Assessment |
|
| Feeling abnormal | Psychiatric disorders | Systematic Assessment |
|
| Body temperature increased | Investigations | Systematic Assessment |
|
| Energy increased | General disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fear of falling | Psychiatric disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Visual impairment | Eye disorders | Systematic Assessment |
|
| Abnormal dreams | Nervous system disorders | Systematic Assessment |
|
| False Sensation | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|
| 110 minutes |
|
| 230 minutes |
|
| Day 1 |
|
| Day 2 |
|
| Day 3 |
|
| Day 7 |
|