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| Name | Class |
|---|---|
| Veeda Clinical Research | INDUSTRY |
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This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with rheumatic disease | Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Physician's Assessment of Disease Activity Over Time | Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity. | Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in Tender Joints Over Time | A total of 28 joints were assessed for tenderness. | Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in Swollen Joints Over Time | A total of 28 joints were assessed for swelling. | Baseline, Months 3, 6, 12, 24, 60 |
| Inflammatory Parameter: Change From Baseline in CRP Over Time | Baseline, Months 3, 6, 12, 24, 60 | |
| Inflammatory Parameter: Change From Baseline in ESR Over Time | Baseline, Months 3, 6, 12, 24, 60 | |
| Physical Function: Change From Baseline in HAQ% Over Time | The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement. |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatologists
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 5940 participants (2845 with rheumatoid arthritis [RA], 1128 with psoriatic arthritis [PsA], and 1967 with ankylosing spondylitis [AS]) were enrolled. Twenty of these participants were younger than 18 years old (9 RA participants, 1 PsA participant, and 10 AS participants); these participants were not included in any analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With RA | Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| FG001 | Participants With PsA | Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| FG002 | Participants With AS | Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With RA | Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| BG001 | Participants With PsA | Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant in the AS arm had missing 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 Physician's Assessment of Disease Activity Over Time | Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity. | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 3, 6, 12, 24, 60 |
|
up to Month 60
The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants diagnosed with RA, PsA or AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2006 | Dec 17, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2018 | Dec 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in DAS28 Over Time: RA Participants | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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, Months 3, 6, 12, 24, 60 |
| DAS28 Category Over Time: RA Participants | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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, Months 3, 6, 12, 24, 60 |
| BSA With PsA Over Time: PsA Participants | Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | Baseline, Months 3, 6, 12, 24, 60 |
| Change From Baseline in BASDAI Over Time: AS Participants | BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms. | Baseline, Months 3, 6, 12, 24, 60 |
| Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified. | up to 60 months |
| BG002 | Participants With AS | Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Physician's Assessment of Disease Activity | Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity. | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | units on a scale |
|
| Tender Joints | A total of 28 joints were assessed for tenderness. | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | tender joints |
|
| Swollen Joints | A total of 28 joints were assessed for swelling. | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | swollen joints |
|
| Inflammatory Parameter: C-Reactive Protein (CRP) | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | mg/dL |
|
| Inflammatory Parameter: Erythrocyte Sedimentation Rate (ESR) | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | mm/hour |
|
| Health Assessment Questionnaire (HAQ%) | The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement. | Includes all participants with a Baseline assessment. | Mean | Standard Deviation | percentage of maximum HAQ score |
|
| Disease Activity Score for 28 Joints (DAS28): RA Participants | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. | Includes all RA participants with a Baseline assessment. | Mean | Standard Deviation | score on a scale |
|
| DAS28 Category | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. | Includes all RA participants with a Baseline assessment. | Count of Participants | Participants |
|
| Body Surface Area (BSA) with PsA | Includes all PsA participants with a Baseline assessment. | Count of Participants | Participants |
|
| Patient's Numerical Rating Scale for Oligarticular PsA Participants | Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | Includes all oligoarticular PsA participants with a Baseline assessment. | Mean | Standard Deviation | units on a scale |
|
| Physician's Numerical Rating Scale for Oligoarticular PsA Participants | Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | Includes all oligoarticular PsA participants with a Baseline assessment by the physican. | Mean | Standard Deviation | units on a scale |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS Participants | BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms. | Includes all AS participants with a Baseline assessment. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Participants With AS | Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. |
|
|
| Primary | Change From Baseline in Tender Joints Over Time | A total of 28 joints were assessed for tenderness. | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | tender joints | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Change From Baseline in Swollen Joints Over Time | A total of 28 joints were assessed for swelling. | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | swollen joints | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Inflammatory Parameter: Change From Baseline in CRP Over Time | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Inflammatory Parameter: Change From Baseline in ESR Over Time | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | mm/hour | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Physical Function: Change From Baseline in HAQ% Over Time | The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement. | All participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | percentage of maximum HAQ score | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Change From Baseline in DAS28 Over Time: RA Participants | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. | All RA participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | DAS28 Category Over Time: RA Participants | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. | All RA participants with a Baseline and post-baseline assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | BSA With PsA Over Time: PsA Participants | All PsA participants with a Baseline and post-baseline assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. | All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Change From Baseline in BASDAI Over Time: AS Participants | BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms. | All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Months 3, 6, 12, 24, 60 |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified. | Posted | Count of Participants | Participants | up to 60 months |
|
|
|
| 54 |
| 5,920 |
| 934 |
| 5,920 |
| 0 |
| 5,920 |
| Antiphospholipid syndrome | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Normochromic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pseudolymphoma | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arteritis coronary | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac asthma | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac hypertrophy | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiomyopathy alcoholic | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coronary artery dilatation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diastolic dysfunction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dilatation atrial | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intracardiac mass | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mitral valve calcification | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mitral valve prolapse | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myocardial calcification | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pleuropericarditis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rheumatic heart disease | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular flutter | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dolichocolon | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thalassaemia | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Trisomy 18 | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Truncus arteriosus persistent | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acromegaly | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Addison's disease | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Basedow's disease | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cushing's syndrome | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Altered visual depth perception | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arcus lipoides | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Exophthalmos | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal symptom | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal melanosis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ileal ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mouth swelling | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Small intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spigelian hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tongue oedema | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vasculitis gastrointestinal | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Catheter site phlebitis | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Crepitations | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cyst | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Drug effect decreased | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hernia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Inflammatory pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Local reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mass | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Microlithiasis | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Multiple-drug resistance | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Necrosis | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| No adverse event | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nodule | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Papillitis | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Paradoxical drug reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Therapy non-responder | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Treatment noncompliance | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Unevaluable event | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Biliary cyst | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cryptogenic cirrhosis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fatty liver alcoholic | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Allergic oedema | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Autoimmune disorder | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Immune system disorder | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Immunosuppression | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Arthritis salmonella | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bursitis infective staphylococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Cranial nerve infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Cystitis klebsiella | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Enterobacter infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Haematoma infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Hepatitis B reactivation | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Legionella infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Leishmaniasis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Meningitis herpes | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Meningitis tuberculous | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Nocardiosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Ophthalmic herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Ovarian abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Papilloma viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pericarditis tuberculous | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Proteus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Purulent discharge | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pyuria | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Sepsis syndrome | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Septic arthritis staphylococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Serratia infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tick-borne viral encephalitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Toxic shock syndrome | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Toxoplasmosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Uterine infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Vaginal abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Varicella zoster virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Drug dose omission | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Foetal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Gastroparesis postoperative | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Nerve injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Albumin globulin ratio increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Alpha 2 globulin increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Angiogram peripheral abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Anti-cyclic citrullinated peptide antibody | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Antibody test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Biopsy breast abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Biopsy skin abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood immunoglobulin M increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood thyroid stimulating hormone abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Body temperature decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Bronchoscopy abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| C-reactive protein abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Carcinoembryonic antigen increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac murmur functional | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Colonoscopy abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Double stranded DNA antibody positive | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Drug level increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Ejection fraction abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Electrocardiogram Q wave abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Epstein-Barr virus antibody positive | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Exercise electrocardiogram abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| General physical condition abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Heart sounds abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic enzyme abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Immunology test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Inflammatory marker increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| International normalised ratio abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Lipids abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Lymphocyte count abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Nuclear magnetic resonance imaging abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary function test decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Pulse abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Pulse absent | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Rheumatoid factor increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Sleep study | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Sputum abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Synovial fluid analysis | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Total lung capacity abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Ultrasound Doppler abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Venous pressure jugular increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cell death | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Central obesity | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fluid intake reduced | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperinsulinaemic hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyposideraemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Increased insulin requirement | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Insulin-requiring type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bone erosion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Calcification of muscle | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eosinophilic fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Inguinal mass | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc space narrowing | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteoporosis postmenopausal | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Osteosclerosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Polychondritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Still's disease | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tendon calcification | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vertebral lesion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Anaplastic large cell lymphoma T- and null-cell types recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Angioimmunoblastic T-cell lymphoma refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign neoplasm of adrenal gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Bladder transitional cell carcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Bronchial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Cervix carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Chronic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Cystadenocarcinoma ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Follicle centre lymphoma, follicular grade I, II, III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Follicular thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Large cell lung cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Linitis plastica | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Lobular breast carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Medullary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Mesenteric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Metastases to adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Metastases to vagina | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Paraproteinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Rectal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Tumour invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Uterine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Waldenstrom's macroglobulinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Acute disseminated encephalomyelitis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anosognosia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Axonal neuropathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Brain compression | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Carotid artery thrombosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cervical radiculopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Complex regional pain syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dysstasia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Encephalitis autoimmune | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intracranial haematoma | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Locked-in syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Meningoradiculitis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Micrographia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neurodegenerative disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Radicular pain | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Spinal claudication | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vasculitis cerebral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (21.0) | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (21.0) | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA (21.0) | Systematic Assessment |
|
| Device loosening | Product Issues | MedDRA (21.0) | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bruxism | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Emotional disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Psychiatric decompensation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bladder irritation | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Calculus urethral | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cystitis interstitial | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diabetic end stage renal disease | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal atrophy | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Epididymal cyst | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic haemorrhage | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chronic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pleural disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary hilum mass | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory tract irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acanthosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Excessive skin | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypersensitivity vasculitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Parakeratosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin dystrophy | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Alcoholic | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Bedridden | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Impaired driving ability | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Impaired work ability | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Loss of personal independence in daily activities | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Poor personal hygiene | Social circumstances | MedDRA (21.0) | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Arterial catheterisation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Arterial stent insertion | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Bladder operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Bone debridement | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Breast prosthesis removal | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Corneal transplant | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Debridement | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Elbow operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Joint stabilisation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Mammoplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Metabolic surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Metatarsal excision | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Nasal operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral nerve decompression | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral nerve operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Plastic surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Prosthesis implantation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Salpingo-oophorectomy unilateral | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Steroid therapy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Suture insertion | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Urinary tract operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Vascular operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Vascular stent insertion | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aneurysm ruptured | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Aortitis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arterial disorder | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arteritis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemodynamic instability | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vascular insufficiency | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vascular occlusion | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vasculitis necrotising | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vein disorder | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Venous aneurysm | Vascular disorders | MedDRA (21.0) | 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 |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
|
| Month 3 DAS28 < 3.2 |
|
|
| Month 6 DAS28 < 2.6 |
|
|
| Month 6 DAS28 ≥ 2.6 to ≤ 3.2 |
|
|
| Month 6 DAS28 < 3.2 |
|
|
| Month 12 DAS28 < 2.6 |
|
|
| Month 12 DAS28 ≥ 2.6 to ≤ 3.2 |
|
|
| Month 12 DAS28 < 3.2 |
|
|
| Month 24 DAS28 < 2.6 |
|
|
| Month 24 DAS28 ≥ 2.6 to ≤ 3.2 |
|
|
| Month 24 DAS28 < 3.2 |
|
|
| Month 60 DAS28 < 2.6 |
|
|
| Month 60 DAS28 ≥ 2.6 to ≤ 3.2 |
|
|
| Month 60 DAS28 < 3.2 |
|
|
| Title | Measurements |
|---|---|
|
| Month 3: 11% to 20% of BSA |
|
|
| Month 3: > 20% of BSA |
|
|
| Month 6: < 3% of BSA |
|
|
| Month 6: 3% to 10% of BSA |
|
|
| Month 6: 11% to 20% of BSA |
|
|
| Month 6: > 20% of BSA |
|
|
| Month 12: < 3% of BSA |
|
|
| Month 12: 3% to 10% of BSA |
|
|
| Month 12: 11% to 20% of BSA |
|
|
| Month 12: > 20% of BSA |
|
|
| Month 24: < 3% of BSA |
|
|
| Month 24: 3% to 10% of BSA |
|
|
| Month 24: 11% to 20% of BSA |
|
|
| Month 24: > 20% of BSA |
|
|
| Month 60: < 3% of BSA |
|
|
| Month 60: 3% to 10% of BSA |
|
|
| Month 60: 11% to 20% of BSA |
|
|
| Month 60: > 20% of BSA |
|
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 60 |
|
|
| Title | Measurements |
|---|---|
|
| Any Fatal AE |
|
| Any AE Leading to Study Drug Discontinuation |
|