Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TREAT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.
Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Volume and dose frequency changes resembling dosing in the active treatment group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| Time to All-cause Mortality | Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21212421 | Background | Lewis EF, Pfeffer MA, Feng A, Uno H, McMurray JJ, Toto R, Gandra SR, Solomon SD, Moustafa M, Macdougall IC, Locatelli F, Parfrey PS; TREAT Investigators. Darbepoetin alfa impact on health status in diabetes patients with kidney disease: a randomized trial. Clin J Am Soc Nephrol. 2011 Apr;6(4):845-55. doi: 10.2215/CJN.06450710. Epub 2011 Jan 6. | |
| 21982669 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
First Subject Enrolled: 25 Aug 2004 Last Subject Enrolled: 04 Dec 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL. |
| FG001 | Darbepoetin Alfa | Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin Alfa | Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
Differential follow-up up to 4.6 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
4047 subjects were enrolled, but before unblinding, all information from 9 subjects was excluded from two sites (3 and 6 subjects, respectively) that did not adhere to Good Clinical Practice guidelines. 4038 subjects were analyzed and reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| darbepoetin alfa |
| Drug |
Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL |
|
| Time to Cardiovascular Mortality | Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Time to Myocardial Infarction | Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Time to Cerebrovascular Accident | Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Time to Congestive Heart Failure | Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Time to End Stage Renal Disease | Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline | GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| Change in Patient Reported Fatigue Relative to Baseline at Week 25 | Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) - Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue | Baseline and week 25 |
| Time to Hospitalization Due to Acute Myocardial Ischemia | Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
| McMurray JJ, Uno H, Jarolim P, Desai AS, de Zeeuw D, Eckardt KU, Ivanovich P, Levey AS, Lewis EF, McGill JB, Parfrey P, Parving HH, Toto RM, Solomon SD, Pfeffer MA. Predictors of fatal and nonfatal cardiovascular events in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia: an analysis of the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin-alfa) Therapy (TREAT). Am Heart J. 2011 Oct;162(4):748-755.e3. doi: 10.1016/j.ahj.2011.07.016. |
| 15864229 | Background | Mix TC, Brenner RM, Cooper ME, de Zeeuw D, Ivanovich P, Levey AS, McGill JB, McMurray JJ, Parfrey PS, Parving HH, Pereira BJ, Remuzzi G, Singh AK, Solomon SD, Stehman-Breen C, Toto RD, Pfeffer MA. Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease. Am Heart J. 2005 Mar;149(3):408-13. doi: 10.1016/j.ahj.2004.09.047. |
| 19880844 | Background | Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R; TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009 Nov 19;361(21):2019-32. doi: 10.1056/NEJMoa0907845. Epub 2009 Oct 30. |
| 20843249 | Background | Solomon SD, Uno H, Lewis EF, Eckardt KU, Lin J, Burdmann EA, de Zeeuw D, Ivanovich P, Levey AS, Parfrey P, Remuzzi G, Singh AK, Toto R, Huang F, Rossert J, McMurray JJ, Pfeffer MA; Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med. 2010 Sep 16;363(12):1146-55. doi: 10.1056/NEJMoa1005109. |
| 37651553 | Derived | Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2. |
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. |
| 26299230 | Derived | Lewis EF, Claggett B, Parfrey PS, Burdmann EA, McMurray JJ, Solomon SD, Levey AS, Ivanovich P, Eckardt KU, Kewalramani R, Toto R, Pfeffer MA. Race and ethnicity influences on cardiovascular and renal events in patients with diabetes mellitus. Am Heart J. 2015 Aug;170(2):322-9. doi: 10.1016/j.ahj.2015.05.008. Epub 2015 May 22. |
| 25452859 | Derived | Bello NA, Pfeffer MA, Skali H, McGill JB, Rossert J, Olson KA, Weinrauch L, Cooper ME, de Zeeuw D, Rossing P, McMurray JJ, Solomon SD. Retinopathy and clinical outcomes in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia. BMJ Open Diabetes Res Care. 2014 Apr 6;2(1):e000011. doi: 10.1136/bmjdrc-2013-000011. eCollection 2014. |
| 22104547 | Derived | Skali H, Parving HH, Parfrey PS, Burdmann EA, Lewis EF, Ivanovich P, Keithi-Reddy SR, McGill JB, McMurray JJ, Singh AK, Solomon SD, Uno H, Pfeffer MA; TREAT Investigators. Stroke in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia treated with Darbepoetin Alfa: the trial to reduce cardiovascular events with Aranesp therapy (TREAT) experience. Circulation. 2011 Dec 20;124(25):2903-8. doi: 10.1161/CIRCULATIONAHA.111.030411. Epub 2011 Nov 21. |
| 19501439 | Derived | Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill J, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R, Uno H; TREAT Investigators. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). Am J Kidney Dis. 2009 Jul;54(1):59-69. doi: 10.1053/j.ajkd.2009.04.008. Epub 2009 Jun 5. |
| 17329707 | Derived | Pfeffer MA; TREAT Executive Committee. An ongoing study of anemia correction in chronic kidney disease. N Engl J Med. 2007 Mar 1;356(9):959-61. doi: 10.1056/NEJMc066568. No abstract available. |
| Death |
|
| Placebo |
Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| History of cardiovascular disease | Cardiovascular disease history is based on the cardiovascular medical history case report form. | Number | Participant |
|
| Baseline proteinuria level | Baseline proteinuria level (g/g creat). Baseline proteinuria is defined as the last non-missing measurement prior or on the day of first investigational product. | Number | Participants |
|
| OG001 | Darbepoetin Alfa | Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed. |
|
|
|
| Primary | Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to All-cause Mortality | Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to Cardiovascular Mortality | Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to Myocardial Infarction | Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to Cerebrovascular Accident | Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to Congestive Heart Failure | Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Time to End Stage Renal Disease | Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline | GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model. | Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| Secondary | Change in Patient Reported Fatigue Relative to Baseline at Week 25 | Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) - Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue | Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and week 25 |
|
|
|
|
| Secondary | Time to Hospitalization Due to Acute Myocardial Ischemia | Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Posted | Number | Participants | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first |
|
|
|
|
| 1,219 |
| 2,019 |
| 1,547 |
| 2,019 |
| EG001 | Darbepoetin Alfa | 1,235 | 2,004 | 1,571 | 2,004 |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| AV dissociation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac valve sclerosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac valve vegetation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diastolic dysfunction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Electromechanical dissociation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Microvascular angina | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nodal arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pacemaker generated arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pleuropericarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Torsade de pointes | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urachal abnormality | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematotympanum | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Otosalpingitis | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cataract cortical | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cataract diabetic | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic blindness | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinal artery thrombosis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinopathy proliferative | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bezoar | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Colonic atony | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal polyp | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatic cyst | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tongue oedema | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Brain death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemic ulcer | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Necrobiosis | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Polyp | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wound necrosis | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatorenal failure | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Acute endocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous graft site infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Breast cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis fungal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cellulitis gangrenous | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cervicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Corynebacterium infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Creutzfeldt-Jakob disease | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Embolic pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Emphysematous cystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Endocarditis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gas gangrene | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Infected bunion | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Intraspinal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Meningitis pneumococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Osteomyelitis acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis fungal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis syndrome | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Subacute endocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Toxic shock syndrome | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection fungal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Uterine abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Wound abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Crush injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Dialysis device complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Eschar | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Eyeball rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Haematuria traumatic | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Heart injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Implantable defibrillator malfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Intraocular lens dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Pacemaker complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Carotid bruit | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Coagulation time prolonged | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Medical observation | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Methicillin-resistant staphylococcal aureus test positive | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acidosis hyperchloraemic | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enzyme abnormality | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperosmolar state | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Adrenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lentigo maligna stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Non-small cell lung cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Paget's disease of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Rectal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Brain mass | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Carotid artery disease | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebellar ischaemia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cervical myelopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic coma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Global amnesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intracranial haematoma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Leukoaraiosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stroke in evolution | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Uraemic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Impaired self-care | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atonic urinary bladder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bladder diverticulum | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bladder stenosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Kidney enlargement | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal artery occlusion | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal papillary necrosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stag horn calculus | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract inflammation | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast calcifications | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast haematoma | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urogenital prolapse | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Laryngeal polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Non-cardiogenic pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wegener's granulomatosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin graft failure | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Social stay hospitalisation | Social circumstances | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal cavity drainage | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Arteriovenous graft | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac pacemaker battery replacement | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Catheterisation cardiac | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Coronary revascularisation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Foot amputation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Removal of inert matter from skin or subcutaneous tissue | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Skin graft | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aorto-duodenal fistula | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arterial disorder | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arterial stenosis limb | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiovascular insufficiency | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic microangiopathy | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Microangiopathy | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Varicophlebitis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vascular insufficiency | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vascular stenosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |