Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1Y-JE-HCLV | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in Japanese adult participants with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg Fluoxetine | Experimental | 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks |
|
| 40 mg Fluoxetine | Experimental | 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo (capsules) administered orally, once daily, for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 471-8513 |
This study consisted of 3 periods: a single-blind screening period (1 week of placebo), a double-blind short-term treatment period (1 week of placebo followed by randomization in a 2:1:3 fashion to 20 milligrams [mg] fluoxetine, 40 mg fluoxetine, or placebo, respectively, for 6 weeks), and a single-blind discontinuation period (2 weeks of placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 mg Fluoxetine | Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks |
| FG001 | 40 mg Fluoxetine | Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks |
| FG002 | Placebo | Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| ||||||||||||||||||||||||
| Discontinuation Period |
|
All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 mg Fluoxetine | 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| BG001 | 40 mg Fluoxetine | 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| 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 | Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score. | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 6 weeks |
|
Not provided
Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Treatment Period) | Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
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| Placebo | Drug |
|
| Baseline, 6 weeks |
| Percentage of Participants Achieving a Response at 6-Week Endpoint | The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100. | up to 6 weeks |
| Percentage of Participants Achieving a Remission at 6-Week Endpoint | The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100. | up to 6 weeks |
| Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale | CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score. | Baseline, 6 weeks |
| Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores | SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score. | Baseline, up to 6 weeks |
| Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. | Baseline through 6 weeks |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 270-0014 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | 800-0226 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukushima | 961-0021 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hiroshima | 737-0143 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | 065-0012 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 651-0097 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 238-0042 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | 616-8421 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nagano | 390-0303 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Okayama | 700-0907 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 586-0012 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | 339-0057 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shiga | 525-0037 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tochigi | 321-0953 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 170-0002 | Japan |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Sponsor Decision |
|
| Lack of Efficacy |
|
| NOT COMPLETED |
|
|
| BG002 | Placebo | Placebo (capsules) administered orally, once daily, for 6 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| OG001 | 40 mg Fluoxetine | 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| OG002 | Placebo | Placebo (capsules) administered orally, once daily, for 6 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score. | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving a Response at 6-Week Endpoint | The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100. | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | Posted | Number | percentage of participants | up to 6 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving a Remission at 6-Week Endpoint | The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100. | Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | Posted | Number | percentage of participants | up to 6 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale | CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score. | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores | SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score. | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, up to 6 weeks |
|
|
|
| Secondary | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. | Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period. | Posted | Number | participants | Baseline through 6 weeks |
|
|
|
| 2 |
| 259 |
| 75 |
| 259 |
| EG001 | 20 mg Fluoxetine (Treatment Period) | AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period | 0 | 168 | 49 | 168 |
| EG002 | 40 mg Fluoxetine (Treatment Period) | AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period | 0 | 83 | 30 | 83 |
| EG003 | Placebo (Discontinuation From Placebo) | AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period | 1 | 145 | 5 | 145 |
| EG004 | Placebo (Discontinuation From 20 mg Fluoxetine) | AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period | 0 | 87 | 5 | 87 |
| EG005 | Placebo (Discontinuation From 40 mg Fluoxetine) | AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period | 0 | 38 | 2 | 38 |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Infertility male | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gingival inflammation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Electrocardiogram st segment depression | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Endoscopy large bowel | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Protein urine | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Qrs axis abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Duodenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anterograde amnesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Impatience | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
|
| Anxiety/Somatization subscale score |
|
| Retardation/Somatization subscale score |
|
| Sleep subscale score |
|
|
| Social/Leisure subscale score (n=167, 81, 259) |
|
| Family/Home subscale score (n=167, 81, 259) |
|
| Title | Measurements |
|---|---|
|