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The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Adults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. | Baseline and 6, 12, 24, 36, 48, and 60 months |
| Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. | Baseline, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Physician Visits in Past 6 Months | Participants self-reported the number of physician visits they had in the past 6 months. | Baseline, 6, 12, 24, 36, 48, and 60 months |
| Number of Inpatient Hospitalizations in Past 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample: Patients with rheumatoid arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Henning Kleine, PhD | AbbVie Deutschland GmbH & Co. KG, Medical Department | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32206973 | Derived | Behrens F, Tony HP, Koehm M, Schwaneck EC, Gnann H, Greger G, Burkhardt H, Schmalzing M. Sustained improvement in work outcomes in employed patients with rheumatoid arthritis during 2 years of adalimumab therapy: an observational cohort study. Clin Rheumatol. 2020 Sep;39(9):2583-2592. doi: 10.1007/s10067-020-05038-y. Epub 2020 Mar 23. | |
| 31867564 |
| Label | URL |
|---|---|
| Related Info | View source |
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Adults with rheumatoid arthritis (RA) were enrolled at 326 clinical centers in Germany and seen during regular visits for routine clinical care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety set included all enrolled participants who received at least one dose of adalimumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants with available data |
| 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 | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at baseline and each time point. | Posted | Mean | Standard Deviation | days | Baseline and 6, 12, 24, 36, 48, and 60 months |
|
60 months
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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 | Adalimumab | Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: original | Oct 28, 2008 | Sep 7, 2018 | Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: amendment | Mar 6, 2012 | Sep 7, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Work Activity Index (WAI) | The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best). | Baseline and 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Tender Joint Count | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Swollen Joint Count | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Erythrocyte Sedimentation Rate | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in C-reactive Protein | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| EuroQol-5 Dimensions (EQ-5D) Scores | The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):
For each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Change From Baseline in Euroqol Visual Analog Scale (VAS) | EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine." | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
Participants self-reported the number of hospitalizations they had in the past 6 months.
| Baseline, 6, 12, 24, 36, 48, and 60 months |
| Duration of Inpatient Hospitalizations in Past 6 Months | Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months. | Baseline, 6, 12, 24, 36, 48, and 60 months |
| Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days. | Baseline, 6, 12, 24, 36, 48, and 60 months |
| Duration of Morning Stiffness | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Participant's Assessment of Pain | Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain). | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Participant's Assessment of Fatigue | Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly). | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
| Percentage of Participants Taking Concomitant RA Medications | Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others. | Baseline to month 60 |
| Patient Assessment of Adalimumab Therapy | Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:
| Months 3, 6, 12, 24, 36, 48, and 60 |
| Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Use of a "critical difference" statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis. BMC Rheumatol. 2019 Dec 10;3:51. doi: 10.1186/s41927-019-0095-2. eCollection 2019. |
| Unknown Reason |
|
| Lost to Follow-up |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Participants with available data | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Duration of Disease | Participants with available data | Mean | Standard Deviation | years |
|
| Number of Missed Work Days in Last 6 Months | Participants who were employed part-time or full-time | Mean | Standard Deviation | days |
|
| Work Productivity and Activity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Participants with available WPAI data; The first 3 scores were assessed in participants who were employed. | Mean | Standard Deviation | percent impairment |
|
| Work Activity Index | The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days. WAI scores range from 7 (worst) to 49 (best). | Participants who were employed part-time or full-time | Mean | Standard Deviation | units on a scale |
|
| Disease Activity Score - 28 Joints (DAS28) | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission. | Participants with available data | Mean | Standard Deviation | units on a scale |
|
| Tender Joint Count | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | Participants with available data | Mean | Standard Deviation | joints |
|
| Swollen Joint Count | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | Participants with available data | Mean | Standard Deviation | joints |
|
| Erythrocyte Sedimentation Rate | Participants with available data | Mean | Standard Deviation | mm/hr |
|
| C-reactive Protein | Participants with available data | Mean | Standard Deviation | mg/L |
|
| Health-Assessment Questionnaire-Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week on the following scale: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Participants with available data | Mean | Standard Deviation | units on a scale |
|
| Euroqol Visual Analog Scale (VAS) | EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The VAS is a vertical scale ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine." | Participants with available data | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at each time point. | Posted | Number | percentage of participants | Baseline, 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data. | Posted | Mean | Standard Deviation | percent impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data. | Posted | Mean | Standard Deviation | percent impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
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| Primary | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data. | Posted | Mean | Standard Deviation | percent impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and with available WPAI data. | Posted | Mean | Standard Deviation | percent impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
|
|
| Primary | Change From Baseline in Work Activity Index (WAI) | The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best). | Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WAI data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
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| Primary | Change From Baseline in Tender Joint Count | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | joints | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in Swollen Joint Count | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | joints | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
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| Primary | Change From Baseline in Erythrocyte Sedimentation Rate | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | mm/hr | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Primary | Change From Baseline in C-reactive Protein | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | mg/L | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
|
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| Primary | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
|
|
| Primary | EuroQol-5 Dimensions (EQ-5D) Scores | The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):
For each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Count of Participants | Participants | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
|
|
| Primary | Change From Baseline in Euroqol Visual Analog Scale (VAS) | EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine." | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Secondary | Number of Physician Visits in Past 6 Months | Participants self-reported the number of physician visits they had in the past 6 months. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | visits | Baseline, 6, 12, 24, 36, 48, and 60 months |
|
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| Secondary | Number of Inpatient Hospitalizations in Past 6 Months | Participants self-reported the number of hospitalizations they had in the past 6 months. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | hospitalizations | Baseline, 6, 12, 24, 36, 48, and 60 months |
|
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| Secondary | Duration of Inpatient Hospitalizations in Past 6 Months | Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | days | Baseline, 6, 12, 24, 36, 48, and 60 months |
|
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| Secondary | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | days | Baseline, 6, 12, 24, 36, 48, and 60 months |
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| Secondary | Duration of Morning Stiffness | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | minutes | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
|
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| Secondary | Participant's Assessment of Pain | Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain). | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
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| Secondary | Participant's Assessment of Fatigue | Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly). | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, 24, 36, 48, and 60 months |
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|
|
| Secondary | Percentage of Participants Taking Concomitant RA Medications | Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others. | Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set). | Posted | Number | percentage of participants | Baseline to month 60 |
|
|
|
| Secondary | Patient Assessment of Adalimumab Therapy | Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:
| Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), with available data at each time point. | Posted | Number | percentage of participants | Months 3, 6, 12, 24, 36, 48, and 60 |
|
|
|
| 23 |
| 7,229 |
| 932 |
| 7,229 |
| 831 |
| 7,229 |
| Knee arthroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Elective surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Therapy cessation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Therapy change | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Laparoscopic surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Osteosynthesis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Antibiotic therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arthroscopic surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Rheumatoid nodule removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Antibiotic prophylaxis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Bursa removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ankle arthroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Baker's cyst excision | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Fracture treatment | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Renal stone removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Abscess drainage | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ankle operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Breast conserving surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cancer surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Emergency care | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Gallbladder operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Haematoma evacuation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Meniscus operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pain management | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Sigmoidectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Skin graft | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Spinal decompression | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Stent placement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arterial stent insertion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Breast reconstruction | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cartilage operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Chemotherapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Infiltration anaesthesia | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint dislocation reduction | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Massage | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nasal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nasal polypectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Open reduction of fracture | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ovarian cystectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Postoperative care | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Prostatic operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary resection | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Removal of internal fixation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tendon sheath incision | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tenoplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Thyroid operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ureteral stent insertion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Wound treatment | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal hernia repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Adhesiolysis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Adrenocortical steroid therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Aneurysm repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Antiallergic therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Anticoagulant therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arterial aneurysm repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arterial bypass operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arterial catheterisation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Arthrotomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Bone operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Bronchial lesion excision | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Bursal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cerebrovascular operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Chest wall operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Coronary revascularisation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cryotherapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Cyst removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Debridement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Diabetes mellitus management | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Femoral hernia repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Fistula repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Fluid replacement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Fracture debridement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Frontal sinus operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Gastric operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Gingival operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Haemostasis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Infusion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Injection | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Intestinal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Jaw operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint debridement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint injection | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Joint stabilisation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Laparotomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ligament operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Lip repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Lithotripsy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Lung transplant | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Lymphoma operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nephroplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Nephrostomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Neurectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Oophorectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ossiculoplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ostectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatic operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Parotidectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Peritoneal lavage | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pharyngeal operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Polypectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pyeloplasty | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Radical prostatectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Radioactive iodine therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Rectal polypectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Renal artery stent placement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Resuscitation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Skin lesion removal | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Spinal cord operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Sternotomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Therapeutic embolisation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Thrombolysis | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Toe amputation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tongue operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Tumour excision | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Unevaluable therapy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ureterectomy | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Ureteric operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Urinary incontinence surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Venous operation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Vertebral body replacement | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Wound closure | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Wrist surgery | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infectious colitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Nasal herpes | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Abscess soft tissue | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Acne pustular | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Candida pneumonia | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Chronic hepatitis C | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Emphysematous cholecystitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gallbladder empyema | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Herpes simplex encephalitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infected seroma | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infection susceptibility increased | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Keratouveitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Meningoencephalitis herpetic | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Mycobacterium marinum infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia necrotising | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Poliomyelitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Pyonephrosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Septic encephalopathy | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Testicular abscess | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tuberculosis of genitourinary system | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tuberculosis of intrathoracic lymph nodes | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Wound infection bacterial | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Acquired claw toe | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spinal instability | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ankle impingement | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bursal haematoma | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Felty's syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hip deformity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ligament pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Meniscal degeneration | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| SAPHO syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Wrist deformity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Accident at work | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Accident at home | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Nerve injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatic duct rupture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Suture related complication | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Unevaluable event | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Perforated ulcer | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| No adverse event | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Granuloma | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Precancerous mucosal lesion | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Atypical fibroxanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Benign cardiac neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Bronchial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Ear neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Epiglottic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Gastric cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Gastric cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Hodgkin's disease mixed cellularity stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Renal cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Adams-Stokes syndrome | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tachycardia induced cardiomyopathy | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Complex regional pain syndrome | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gliosis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Post polio syndrome | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Spinal cord ischaemia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vertebral artery dissection | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Colitis microscopic | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Erosive duodenitis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gingival recession | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Leukoplakia oral | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatic duct stenosis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Salivary gland pain | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ulcerative gastritis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rheumatoid lung | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary hilum mass | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Bronchoscopy | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Biopsy bone marrow | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Biopsy liver | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Computerised tomogram thorax abnormal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Double stranded DNA antibody positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Angiogram peripheral | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Autoantibody test | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Biopsy lymph gland | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Blood bactericidal activity | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Blood calcium | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Colonoscopy normal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| DNA antibody positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Emergency care examination | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Endoscopic retrograde cholangiopancreatography | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Endoscopy | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Epstein-Barr virus antibody positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Laparoscopy | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Mediastinoscopy | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Mycobacterium tuberculosis complex test positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Neurological examination | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Proteus test positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Ultrasound abdomen abnormal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Wound healing normal | Investigations | MedDRA v20.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lividity | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Mucocutaneous ulceration | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Skin hypertrophy | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Urticarial vasculitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Aortic dilatation | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lymphatic fistula | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Microembolism | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bladder diverticulum | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bladder stenosis | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Renal artery arteriosclerosis | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Urinary tract inflammation | Renal and urinary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gallbladder perforation | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA v20.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Acute stress disorder | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Panic reaction | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tobacco abuse | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Shock hypoglycaemic | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ovarian adhesion | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Prostatic dysplasia | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA v20.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA v20.1 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA v20.1 | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA v20.1 | Systematic Assessment |
|
| Basedow's disease | Endocrine disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
|
| Otosclerosis | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Ophthalmic vein thrombosis | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA v20.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Immunosuppression | Immune system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA v20.1 | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA v20.1 | Systematic Assessment |
|
| Device breakage | Product Issues | MedDRA v20.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v20.1 | Systematic Assessment |
|
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v20.1 | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v20.1 | Systematic Assessment |
|
| Alcohol use | Social circumstances | MedDRA v20.1 | Systematic Assessment |
|
| Foreign travel | Social circumstances | MedDRA v20.1 | Systematic Assessment |
|
| Postmenopause | Social circumstances | MedDRA v20.1 | Systematic Assessment |
|
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA v20.1 | Systematic Assessment |
|
| Hereditary neuropathic amyloidosis | Congenital, familial and genetic disorders | MedDRA v20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v20.1 | Systematic Assessment |
|
| Therapy cessation | Surgical and medical procedures | MedDRA v20.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 48 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Self-care |
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| Usual activities |
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| Pain/discomfort |
|
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| Anxiety/depression |
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| Month 12 |
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| Month 24 |
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| Month 36 |
|
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| Month 48 |
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| Month 60 |
|
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| General practitioner |
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| Orthopedic specialist |
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| Other specialists |
|
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| Month 12 |
|
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| Month 24 |
|
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Child-rearing/parenting |
|
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| Educational |
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| Recreational |
|
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| Month 6 |
|
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 6 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
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| Month 6 |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| Month 48 |
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| Month 60 |
|
|
| Sulfasalazine |
|
| Analgesics |
|
| NSAIDs or coxibs |
|
| Systemic glucocorticoids |
|
| Other |
|
| Better |
|
| About the same |
|
| Worse |
|
| Noticeably worse |
|
| Some problems |
|
| Extreme problems |
|
| Some problems |
|
| Extreme problems |
|
| Some problems |
|
| Extreme problems |
|
| Some problems |
|
| Extreme problems |
|