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| ID | Type | Description | Link |
|---|---|---|---|
| B9R-MC-GDGA | Other Identifier | Eli Lilly and Company |
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The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician.
While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin replacement treatment | Adult participants with growth hormone deficiency receiving somatropin replacement treatment. |
| |
| No treatment | Adult participants with growth hormone deficiency receiving no somatropin replacement treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin (rDNA origin) | Drug | Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Adverse Events | A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record. | Baseline to study completion (approximately 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) | Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. | Baseline, interim time point (5 years), and study completion (10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died While in the Study | Study enrollment up to approximately 10 years |
Inclusion Criteria:
- Adult growth hormone deficiency as per the local Humatrope label and as judged by the attending physician
Exclusion Criteria:
- As per the local Humatrope label and as judged by the attending physician
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Clinics, private practices
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25233155 | Derived | Mo D, Blum WF, Rosilio M, Webb SM, Qi R, Strasburger CJ. Ten-year change in quality of life in adults on growth hormone replacement for growth hormone deficiency: an analysis of the hypopituitary control and complications study. J Clin Endocrinol Metab. 2014 Dec;99(12):4581-8. doi: 10.1210/jc.2014-2892. | |
| 24122237 | Derived |
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Participants were initially enrolled in 2 regional observational studies (B9R-EW-GDDQ [GDDQ] initiated in 1997 and B9R-MC-GDEE [GDEE] in 1998) which were merged into the global Study B9R-MC-GDGA (GDGA, NCT01088399) in 2002. This record spans approximately 15 years from the initial enrollment in regional studies to completion of Study GDGA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin Treated | Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants. |
| FG001 | Untreated | Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants. |
| FG002 | It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin Treated | Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants. |
| BG001 | Untreated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Clinically Significant Adverse Events | A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record. | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated). | Posted | Number | percentage of participants | Baseline to study completion (approximately 10 years) |
|
Study enrollment up to approximately 10 years.
All participants with baseline and at least 1 post-baseline visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somatropin Treated | Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D007018 | Hypopituitarism |
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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DNA Addendum - implemented in Germany only. Germany: DNA sample is kept, if participant consented to German DNA Addendum
|
| Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) |
Change in SBP and DBP were used as an indicator of cardiovascular risk. |
| Baseline, interim time point (5 years), and study completion (10 years) |
| Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides | Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented. | Baseline, interim time point (5 years), and study completion (10 years) |
| Cardiovascular Risk Factor-Change From Baseline in Waist Circumference | Change in waist circumference was used as an indicator of cardiovascular risk. | Baseline, interim time point (5 years), and study completion (10 years) |
| Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence) | Baseline through 10 years |
| Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). | QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction). | Baseline, interim time point (5 years), and study completion (10 years) |
| Mo D, Hardin DS, Erfurth EM, Melmed S. Adult mortality or morbidity is not increased in childhood-onset growth hormone deficient patients who received pediatric GH treatment: an analysis of the Hypopituitary Control and Complications Study (HypoCCS). Pituitary. 2014 Oct;17(5):477-85. doi: 10.1007/s11102-013-0529-6. |
| 23823978 | Derived | Shimatsu A, Tai S, Imori M, Ihara K, Taketsuna M, Funai J, Tanaka T, Teramoto A, Irie M, Chihara K. Efficacy and safety of growth hormone replacement therapy in Japanese adults with growth hormone deficiency: a post-marketing observational study. Endocr J. 2013;60(10):1131-44. doi: 10.1507/endocrj.ej13-0083. Epub 2013 Jul 4. |
| 21543424 | Derived | Attanasio AF, Jung H, Mo D, Chanson P, Bouillon R, Ho KK, Lamberts SW, Clemmons DR; HypoCCS International Advisory Board. Prevalence and incidence of diabetes mellitus in adult patients on growth hormone replacement for growth hormone deficiency: a surveillance database analysis. J Clin Endocrinol Metab. 2011 Jul;96(7):2255-61. doi: 10.1210/jc.2011-0448. Epub 2011 May 4. |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Change to or start of somatropin therapy |
|
| Sponsor decision |
|
| Protocol Violation |
|
| Enrollment criteria not met |
|
| Study summary visit not completed |
|
Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
| BG002 | Unknown | It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Growth Hormone Deficiency (GHD) Onset Type | Number | participants |
|
| Insulin-like Growth Factor-I (IGF-I) | Participants with available IGF-I data at baseline (n=5531, 1009, 194 with 6734 total participants). IGF-I is primary mediator of growth hormone (GH) and is used to monitor GH effectiveness, treatment adherence and IGF-I excess. | Mean | Standard Deviation | micrograms per liter (mcg/L) |
|
| IGF-I Standard Deviations Score (SDS) | Participants with available IGF-I SDS data at baseline (n=3743, 645, 113 with 4501 total participants). IGF-I is primary mediator of growth hormone (GH) and is used to monitor GH effectiveness, treatment adherence and IGF-I excess. As endogenous levels of GH, thereby IGF-I, decline throughout adulthood values are converted to age and gender adjusted standard deviation scores (SDS) based on general population normal data. The SDS is the number of standard deviations a subjects IGF-I concentration is different from the general population mean, either positive or negative. | Mean | Standard Deviation | standard deviation scores |
|
| Maximum Growth Hormone (GH) Peak on Stimulation Test | Participants with available maximum GH peak data at baseline (N=1175, 103, 51 with 1329 total participants analyzed). Maximum GH peak levels in response to medication (such as insulin or growth hormone releasing hormone (GHRH) plus arginine) or other intervention (such as exercise) was used to measure the ability of the pituitary gland to release GH and to diagnose and determine severity of GH deficiency. Severe GH deficiency in adults is a peak GH response of <3 milligrams/liter in response to an insulin tolerance test and is an accepted criterion for GH replacement therapy in adults. | Mean | Standard Deviation | nanograms per milliliter (ng/mL) |
|
| Body Mass Index (BMI) | Participants with available BMI data at baseline (n=8263, 1452, 268, with 9983 total participants). Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Diagnosis Leading to GHD | Participants with available diagnosis designation at baseline (n=8670, 1616, 276, with 10562 total participants). Other less common specified diagnoses contains participants who had histories including cranial irradiation, empty sella, hypophysitis, congenital defect resulting in GHD. | Number | participants |
|
Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
|
|
| Secondary | Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) | Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data. | Posted | Mean | Standard Deviation | kilogram per square meter (kg/m^2) | Baseline, interim time point (5 years), and study completion (10 years) |
|
|
|
| Secondary | Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) | Change in SBP and DBP were used as an indicator of cardiovascular risk. | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, interim time point (5 years), and study completion (10 years) |
|
|
|
| Secondary | Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides | Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented. | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, interim time point (5 years), and study completion (10 years) |
|
|
|
| Secondary | Cardiovascular Risk Factor-Change From Baseline in Waist Circumference | Change in waist circumference was used as an indicator of cardiovascular risk. | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, interim time point (5 years), and study completion (10 years) |
|
|
|
| Secondary | Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence) | All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information. | Posted | Number | percentage of participants | Baseline through 10 years |
|
|
|
| Secondary | Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). | QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction). | All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score. | Posted | Mean | Standard Deviation | Z-score | Baseline, interim time point (5 years), and study completion (10 years) |
|
|
|
| Other Pre-specified | Number of Participants Who Died While in the Study | All participants with baseline and at least 1 post-baseline visit. | Posted | Number | participants | Study enrollment up to approximately 10 years |
|
|
|
| 1,602 |
| 8,420 |
| 4,912 |
| 8,420 |
| EG001 | Untreated | Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants. | 288 | 1,269 | 591 | 1,269 |
| EG002 | It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants. | 0 | 4 | 0 | 4 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrioventricular dissociation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Subendocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ventricular hypertrophy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Wolff-parkinson-white syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arnold-chiari malformation | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diencephalic syndrome of infancy | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysmorphism | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gene mutation | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Porphyria | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Endolymphatic hydrops | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Addison's disease | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adrenal disorder | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carcinoid syndrome | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperadrenocorticism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypophysitis | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypothalamo-pituitary disorder | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphocytic hypophysitis | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nelson's syndrome | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary cyst | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary enlargement | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary haemorrhage | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary-dependent cushing's syndrome | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retinal vein thrombosis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Scotoma | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Appendix disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetic enteropathy | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ileitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mesenteric occlusion | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophageal dilatation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatic necrosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Salivary gland mass | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Device failure | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fibrosis | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Implant site irritation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Medical device pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Multi-organ disorder | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Polyp | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pseudocyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Biliary dilatation | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal wall infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Appendiceal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Breast cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Colostomy infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Corneal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Creutzfeldt-jakob disease | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cystitis klebsiella | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cytomegalovirus mononucleosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Echinococciasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Encephalitic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gallbladder empyema | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infectious peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Joint abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Meningoencephalitis bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia herpes viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Purulent discharge | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Subacute endocarditis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viral pericarditis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Delayed effects of radiation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Graft complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Joint dislocation postoperative | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis chemical | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Mountain sickness acute | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Poisoning deliberate | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Postoperative adhesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Uterine rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Amniotic fluid volume increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Anticoagulation drug level below therapeutic | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Aspiration bone marrow | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Aspiration pleural cavity | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Band neutrophil count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood cortisol decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood cortisol increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood electrolytes abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchoscopy | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Cortisol free urine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Drug level below therapeutic | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Drug level increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Endoscopy | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Haematocrit increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hysteroscopy | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Immunosuppressant drug level decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Nuclear magnetic resonance imaging brain abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Smear cervix abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Ureteroscopy | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hip deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pelvic deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| B-cell lymphoma stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Benign neoplasm of testis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Benign oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Benign respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Carotid body tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Cns germinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colon cancer stage ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Craniopharyngioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Craniopharyngioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Dermatofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Endometrial cancer stage i | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Ewing's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Germ cell cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lip neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung adenocarcinoma stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Malignant glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Malignant neoplasm of islets of langerhans | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Malignant soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Mantle cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Medulloblastoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Mixed oligo-astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Neurofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Non-hodgkin's lymphoma stage ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Non-secretory adenoma of pituitary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Optic nerve neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatic sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Penis carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pleural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Rhabdomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Secretory adenoma of pituitary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Basilar artery thrombosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carotid aneurysm rupture | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carotid artery aneurysm | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral cyst | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral thrombosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Coma hepatic | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Guillain-barre syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hemianopia heteronymous | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intracranial hypotension | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ivth nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mononeuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Moyamoya disease | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Quadriplegia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal cord oedema | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Viith nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Visual pathway disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vith nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abnormal labour | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug dependence, postpartum | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Crush syndrome | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hydroureter | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vesical fistula | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Artificial menopause | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Breast enlargement | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Endometrial disorder | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Menopausal disorder | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian mass | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prostatism | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rectocele | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Testicular atrophy | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Broncholithiasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neonatal hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alcohol use | Social circumstances | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal hernia repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal panniculectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Adhesiolysis | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Adrenalectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Aneurysm repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Arterial bypass operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Bladder operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Brain operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Breast lump removal | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Carotid artery bypass | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Central venous catheterisation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Cholelithotomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Colectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Colostomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Craniotomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Enterostomy closure | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Ethmoid sinus surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Explorative laparotomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Foraminotomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Gallbladder operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Haematoma evacuation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Haemodialysis | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Hernia hiatus repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| High frequency ablation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Hypophysectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Ileostomy closure | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Incisional drainage | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Incisional hernia repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Intestinal resection | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Lipoma excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Lithotripsy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Liver transplant | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Lung transplant | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Malignant breast lump removal | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Mechanical ventilation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Medical device implantation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Meningeal repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Meningioma surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Meniscus operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Nasal polypectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Open reduction of fracture | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Osteosynthesis | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Ovarian cystectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Parathyroidectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral nerve decompression | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary gland radiotherapy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Pituitary tumour removal | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Plastic surgery to the face | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Preoperative care | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Prostatic operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Rectal prolapse repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Renal tumour excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Salivary gland operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Salpingo-oophorectomy bilateral | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Sigmoidectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Sinus antrostomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Skin graft | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Sphenoid sinus operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Spinal decompression | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Splenectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Stent placement | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Subdural haematoma evacuation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Thyroid operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Tumour excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Urethral repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Wound closure | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Wound treatment | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic occlusion | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Artery dissection | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthostatic hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vein disorder | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Change in DBP at 5 years (n=2740, 272) |
|
| Change in DBP at 10 years (n=955, 73) |
|
| Change in HDL-C at 5 years (n=1667, 176) |
|
| Change in HDL-C at 10 years (n=615, 51) |
|
| Change in LDL-C at 5 years (1435, 166) |
|
| Change in LDL-C at 10 years (n=522, 47) |
|
| Change in Triglycerides at 5 years (n=1581, 178) |
|
| Change in Triglycerides at 10 years (n=571, 51) |
|