Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab (Humira) Treatment | Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Registry Treatment-Emergent Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below. | Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit | The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
Not provided
Not provided
Not provided
Patients with Crohn's disease who have been prescribed adalimumab according to the local label.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38216022 | Derived | Ahuja D, Luo J, Qi Y, Syal G, Boland BS, Chang J, Ma C, Jairath V, Xu R, Singh S. Impact of Treatment Response on Risk of Serious Infections in Patients With Crohn's Disease: Secondary Analysis of the PYRAMID Registry. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1286-1294.e4. doi: 10.1016/j.cgh.2024.01.003. Epub 2024 Jan 11. | |
| 29867173 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
A total of 6 participants less than 18 years of age were enrolled in the study. Participants were permitted to re-enroll after discontinuing the study. Of the 2811 participants who discontinued study, 339 re-enrolled in the study; 102 participants discontinued from the study after re-enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab (Humira) Treatment | Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Treated Population: All participants who received at least 1 injection of Humira in the registry
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab (Humira) Treatment | Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
| 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 | Number of Participants With Registry Treatment-Emergent Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below. | All Treated Population: All participants who received at least 1 injection of Humira in the registry | Posted | Count of Participants | Participants | No | Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years). |
Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Treatment-emergent AEs (TEAEs) of special interest were intended to be collected; however, if TEAEs were spontaneously reported by the participant, they were also analyzed.
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 | Adalimumab (Humira) Treatment | Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit | The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit | Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit | Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit | The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit | Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint.. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint. | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
| D'Haens G, Reinisch W, Panaccione R, Satsangi J, Petersson J, Bereswill M, Arikan D, Perotti E, Robinson AM, Kalabic J, Alperovich G, Thakkar R, Loftus EV. Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-Up in the Pyramid Registry. Am J Gastroenterol. 2018 Jun;113(6):872-882. doi: 10.1038/s41395-018-0098-4. Epub 2018 Jun 5. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit | The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit | The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit | Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements. | Posted | Mean | Standard Deviation | percentage of work time missed | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit | Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements. | Posted | Mean | Standard Deviation | percentage of impairment while working | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit | The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements. | Posted | Mean | Standard Deviation | percentage of overall work impairment | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit | Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements. | Posted | Mean | Standard Deviation | percentage of activity impairment | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office. | Posted | Mean | Standard Deviation | number of visits at physician's office | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room. | Posted | Mean | Standard Deviation | number of visits at emergency room | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint.. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for "total days in hospital" and at least one admission to hospital. | Posted | Mean | Standard Deviation | number of admissions to hospital | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| Secondary | Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint. | All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for "total days in hospital". | Posted | Mean | Standard Deviation | total days in hospital | Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months |
|
|
|
| 1,853 |
| 5,025 |
| 958 |
| 5,025 |
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| BONE MARROW OEDEMA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| IMMUNE THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SICKLE CELL ANAEMIA WITH CRISIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTERIOSPASM CORONARY | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| BRADYARRHYTHMIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CARDIAC VALVE DISEASE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CARDIOVASCULAR DISORDER | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CORONARY ARTERY EMBOLISM | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUPRAVENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| VITELLO-INTESTINAL DUCT REMNANT | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| BASEDOW'S DISEASE | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| GOITRE | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| CORNEAL DISORDER | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPISCLERITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| RETINOPATHY | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| SCLERITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| ULCERATIVE KERATITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL ADHESIONS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL HERNIA OBSTRUCTIVE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL MASS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL WALL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABNORMAL FAECES | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL SPHINCTER ATONY | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANOGENITAL DYSPLASIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| AUTOIMMUNE PANCREATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COELIAC ARTERY COMPRESSION SYNDROME | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COLON DYSPLASIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COLONIC FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEFAECATION URGENCY | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIEULAFOY'S VASCULAR MALFORMATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DUODENAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTERITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCOLONIC FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCUTANEOUS FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| EROSIVE OESOPHAGITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FAECAL INCONTINENCE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FAECALOMA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEMORAL HERNIA STRANGULATED | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA OF SMALL INTESTINE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FREQUENT BOWEL MOVEMENTS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FUNCTIONAL GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRIC FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL DYSPLASIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL NECROSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HERNIAL EVENTRATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ILEAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INCARCERATED UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFLAMMATORY BOWEL DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFREQUENT BOWEL MOVEMENTS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERNAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL DILATATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL FIBROSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL MASS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL MUCOSAL HYPERTROPHY | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL POLYP | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTRA-ABDOMINAL HAEMATOMA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTUSSUSCEPTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| JEJUNAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| JEJUNAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOCALISED INTRAABDOMINAL FLUID COLLECTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| MEGACOLON | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| MESENTERIC VEIN THROMBOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NARCOTIC BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OMENTAL INFARCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ORAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCREATIC PSEUDOCYST | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCREATITIS NECROTISING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANCREATITIS RELAPSING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAPILLA OF VATER STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERITONEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PHARYNGO-OESOPHAGEAL DIVERTICULUM | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMATOSIS INTESTINALIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| POUCHITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROCTITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PSEUDOPOLYPOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL DISCHARGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL SPASM | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SHORT-BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| VOLVULUS OF SMALL BOWEL | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CATHETER SITE DISCHARGE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CYST | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE DISLOCATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE ISSUE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE LEAKAGE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DISCOMFORT | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG EFFECT DECREASED | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG INTOLERANCE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPLASIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FIBROSIS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTHERMIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFLAMMATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOCAL SWELLING | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MASS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| NO THERAPEUTIC RESPONSE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| SENSATION OF FOREIGN BODY | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUDDEN DEATH | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| TREATMENT FAILURE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGITIS CHRONIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGITIS SCLEROSING | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLELITHIASIS OBSTRUCTIVE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CIRRHOSIS ALCOHOLIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| GALLBLADDER DISORDER | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC NECROSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATITIS ALCOHOLIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATORENAL SYNDROME | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| NODULAR REGENERATIVE HYPERPLASIA | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| PORTAL HYPERTENSION | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| PORTAL VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| AMYLOIDOSIS | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| KIDNEY TRANSPLANT REJECTION | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| TRANSPLANT REJECTION | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL WALL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS INTESTINAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS JAW | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS LIMB | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANAL FISTULA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BARTHOLIN'S ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BARTHOLINITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BILIARY SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRAIN ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CANDIDA PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGITIS INFECTIVE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DISSEMINATED TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ENDOCARDITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EPSTEIN-BARR VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FALLOPIAN TUBE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FUNGAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FUNGAL PERITONITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GAS GANGRENE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS NOROVIRUS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL HERPES | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GROIN ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| H1N1 INFLUENZA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HAEMATOMA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HELICOBACTER GASTRITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HELICOBACTER INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HEPATITIS C | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES OESOPHAGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES OPHTHALMIC | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES SIMPLEX | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES ZOSTER OTICUS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HIV INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| IMPETIGO | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INCISION SITE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTED CYST | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTION PARASITIC | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| KIDNEY INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LEGIONELLA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LISTERIOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LUNG ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LYMPHADENITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MASTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MASTOIDITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MENINGITIS VIRAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MUSCLE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OPHTHALMIC HERPES SIMPLEX | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OTITIS EXTERNA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OVERGROWTH BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PAROTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC INFLAMMATORY DISEASE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERINEAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIORBITAL CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERITONEAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERITONITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIUMBILICAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERTUSSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA CHLAMYDIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA MYCOPLASMAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA PSEUDOMONAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PSOAS ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RENAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RETROPERITONEAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RICKETTSIOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SALMONELLOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SALPINGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SCROTAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SIALOADENITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SKIN CANDIDA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STOMA SITE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STREPTOCOCCAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SUBDIAPHRAGMATIC ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SUPERINFECTION BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TORULOPSIS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TRACHEITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TRACHEOBRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TUBERCULOSIS GASTROINTESTINAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TUBO-OVARIAN ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VARICELLA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VARICELLA ZOSTER PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VIRAL PHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VULVAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VULVAL CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC FISTULA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC LEAK | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC STENOSIS | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC ULCER | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC ULCER HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| COLON INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| COMPLICATIONS OF TRANSPLANTED KIDNEY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL ANASTOMOSIS COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| NERVE INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMOTHORAX TRAUMATIC | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PROCEDURAL INTESTINAL PERFORATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PROCEDURAL NAUSEA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| SCAR | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| SPLENIC RUPTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| STOMA SITE INFLAMMATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| SUTURE RELATED COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| TRAUMATIC ULCER | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE RUPTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND DECOMPOSITION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND SECRETION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| BACTERIAL TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| CLOSTRIDIUM TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| CSF CULTURE POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| CULTURE URINE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| OXYGEN SATURATION DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| PROTEIN TOTAL ABNORMAL | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOPROTEINAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| OBESITY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| VITAMIN B12 DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA DISCHARGE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FRACTURE NONUNION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC COMPRESSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SERONEGATIVE ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACROCHORDON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ADENOID CYSTIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ANAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ANOGENITAL WARTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BLADDER CANCER STAGE I, WITHOUT CANCER IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BREAST CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CARCINOID TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CARCINOID TUMOUR OF THE APPENDIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| COLON CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| COLON CANCER STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| COLORECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| GALLBLADDER ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| GALLBLADDER CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| INTRADUCTAL PAPILLOMA OF BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| INTRAOCULAR MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LUNG ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| METASTASES TO PERITONEUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| METASTATIC LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MYCOSIS FUNGOIDES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| NEUROENDOCRINE CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| PARATHYROID TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SEMINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SMALL CELL LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINE ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF THE VULVA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| T-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| TESTIS CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| VULVAL CANCER STAGE 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| ARACHNOIDITIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ATAXIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CAROTID ARTERY ANEURYSM | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBRAL ARTERY EMBOLISM | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBRAL CYST | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CEREBROVASCULAR DISORDER | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEMYELINATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSARTHRIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| EXTRAPYRAMIDAL DISORDER | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEMIPARESIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERCOSTAL NEURALGIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTRACRANIAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEUROLOGICAL DECOMPENSATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| OPTIC NEURITIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYNEUROPATHY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| RUPTURED CEREBRAL ANEURYSM | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| UPPER MOTOR NEURONE LESION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABORTION | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| ABORTION SPONTANEOUS COMPLETE | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| COMPLICATION OF DELIVERY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| DELAYED DELIVERY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| FOETAL DEATH | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| HYDROPS FOETALIS | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| PRE-ECLAMPSIA | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| PREMATURE RUPTURE OF MEMBRANES | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| PROLONGED PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| RUPTURED ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| STILLBIRTH | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| AFFECTIVE DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG DEPENDENCE | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| EATING DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| OBSESSIVE-COMPULSIVE DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| GLOMERULONEPHRITIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| OBSTRUCTIVE UROPATHY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| PELVI-URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| STRESS URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URETERIC STENOSIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URGE INCONTINENCE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| BARTHOLIN'S CYST | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| BREAST DYSPLASIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| BREAST HYPERPLASIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| CERVIX DISORDER | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| CERVIX INFLAMMATION | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENDOMETRIAL HYPERPLASIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENDOMETRIAL THICKENING | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEMALE GENITAL TRACT FISTULA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL PAIN | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFERTILITY | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| OEDEMA GENITAL | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| OVARIAN CYST RUPTURED | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC ADHESIONS | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC FLUID COLLECTION | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERINEAL FISTULA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERINEAL PAIN | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL DISORDER | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL FISTULA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VARICOCELE | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHOLITHIASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL POLYPS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL TURBINATE ABNORMALITY | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PULMONARY SARCOIDOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| CUTANEOUS LUPUS ERYTHEMATOSUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| GUTTATE PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HENOCH-SCHONLEIN PURPURA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERTRIGO | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PUSTULAR PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PYODERMA GANGRENOSUM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH FOLLICULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| COLOSTOMY | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| DRUG DETOXIFICATION | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| HYSTERECTOMY | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL ANASTOMOSIS | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| AORTIC ANEURYSM | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| AORTIC DISSECTION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| AORTIC THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTERIAL THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| BEHCET'S SYNDROME | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| EMBOLISM | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHAGE | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOVOLAEMIC SHOCK | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERIPHERAL EMBOLISM | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYARTERITIS NODOSA | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| VASCULITIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERGAMMAGLOBULINAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LYMPHOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MACROCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPLENIC VEIN THROMBOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| THROMBOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| EXTRASYSTOLES | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEREDITARY FRUCTOSE INTOLERANCE | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTROPHIC CARDIOMYOPATHY | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOACUSIS | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| AUTOIMMUNE THYROIDITIS | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| BASEDOW'S DISEASE | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERPARATHYROIDISM | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHALAZION | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPISCLERITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| EYE INFLAMMATION | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRIDOCYCLITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| PUNCTATE KERATITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| SCLERITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL ADHESIONS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL MASS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL TENDERNESS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL INFLAMMATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL PRURITUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANAL ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANORECTAL SWELLING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHAPPED LIPS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHEILITIS GRANULOMATOSA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COELIAC DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DENTAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULUM | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DUODENAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DUODENITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTERITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCOLONIC FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCUTANEOUS FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FAECAL INCONTINENCE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA OF SMALL INTESTINE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| FREQUENT BOWEL MOVEMENTS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL MOTILITY DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GLOSSITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HERNIAL EVENTRATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ILEAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL FISTULA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| JEJUNAL ULCER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LIP SWELLING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOCALISED INTRAABDOMINAL FLUID COLLECTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUCOUS STOOLS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL FOOD IMPACTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ORAL LICHEN PLANUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ORAL MUCOSAL ERUPTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PALATAL DYSPLASIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERIANAL ERYTHEMA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROCTITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL LESION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL TENESMUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SMALL INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| TONGUE DISCOLOURATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| TOOTH LOSS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ADVERSE DRUG REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| APPLICATION SITE PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CYST | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG EFFECT DECREASED | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG INEFFECTIVE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG INTOLERANCE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEELING ABNORMAL | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| GRANULOMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| HERNIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFLAMMATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE INDURATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE INFLAMMATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE IRRITATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE OEDEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE PRURITUS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE RASH | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE SWELLING | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE WARMTH | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PARADOXICAL DRUG REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PERIPHERAL SWELLING | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PUNCTURE SITE REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| XEROSIS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLANGITIS SCLEROSING | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| FATTY LIVER ALCOHOLIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| GALLBLADDER DISORDER | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC CYST | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC FIBROSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATOSPLENOMEGALY | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| LIVER INJURY | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SERUM SICKNESS | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL WALL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ABSCESS LIMB | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ACUTE SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANGULAR CHEILITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BACTERIAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BARTHOLIN'S ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BARTHOLINITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BODY TINEA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BORRELIA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHLAMYDIAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC HEPATITIS C | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CRYPTOCOCCOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CRYPTOSPORIDIOSIS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DERMO-HYPODERMITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ECZEMA INFECTED | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROBIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCOCCAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ENTEROCOCCAL SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EPSTEIN-BARR VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EYE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EYE INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS NOROVIRUS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL HERPES | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL INFECTION FUNGAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GINGIVAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GROIN ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GYNAECOLOGICAL CHLAMYDIA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES OPHTHALMIC | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES SIMPLEX | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HIV INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INCISION SITE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTIOUS MONONUCLEOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFUSION SITE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MASTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MASTOIDITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MOLLUSCUM CONTAGIOSUM | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MYCOBACTERIUM MARINUM INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| NAIL CANDIDA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| NASAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ONYCHOMYCOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OPHTHALMIC HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ORAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OTITIS EXTERNA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| OVERGROWTH BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PAPILLOMA VIRAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PAROTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC INFLAMMATORY DISEASE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIODONTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA KLEBSIELLA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PURULENT DISCHARGE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SALPINGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SIALOADENITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SKIN BACTERIAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SKIN CANDIDA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STOMA SITE ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| STOMA SITE CANDIDA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SUPERINFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TRICHOPHYTOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UREAPLASMA INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION ENTEROCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VARICELLA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VULVOVAGINAL CANDIDIASIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ACCIDENT AT HOME | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC STENOSIS | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANASTOMOTIC ULCER | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| CHEST INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FOREIGN BODY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| POST PROCEDURAL INFLAMMATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| SEROMA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| STOMA SITE PAIN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| SUBCUTANEOUS HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND SECRETION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| ALPHA 1 FOETOPROTEIN INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| BLOOD IRON DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| CRYSTAL URINE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| DOUBLE STRANDED DNA ANTIBODY POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| GIARDIA TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| HUMAN PAPILLOMA VIRUS TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| RED BLOOD CELLS URINE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| SERUM FERRITIN DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| STOOL TRYPSIN | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| TUBERCULIN TEST POSITIVE | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| VITAMIN B12 DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMOCHROMATOSIS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| LATENT AUTOIMMUNE DIABETES IN ADULTS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYDIPSIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| VITAMIN B12 DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANKYLOSING SPONDYLITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FISTULA DISCHARGE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SJOGREN'S SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPINAL DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPONDYLOARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TEMPOROMANDIBULAR JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDON DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANOGENITAL WARTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CARCINOMA IN SITU OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| NEUROENDOCRINE TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| PENILE WART | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BENIGN INTRACRANIAL HYPERTENSION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| BURNING SENSATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| CLUSTER HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEMYELINATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MIGRAINE WITH AURA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPEECH DISORDER | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| TEMPORAL LOBE EPILEPSY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE CONTRACTIONS DURING PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| AGITATION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANTICIPATORY ANXIETY | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| MENTAL DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| PANIC REACTION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| STRESS | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| BLADDER SPASM | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| IGA NEPHROPATHY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URETHRAL DISORDER | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| BALANOPOSTHITIS | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| FEMALE GENITAL TRACT FISTULA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| MENOPAUSAL SYMPTOMS | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE DISORDER | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VULVAL ULCERATION | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VULVAR EROSION | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| VULVOVAGINAL ERYTHEMA | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA PAROXYSMAL NOCTURNAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOVENTILATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NASAL ULCER | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPUTUM DISCOLOURED | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| THROAT TIGHTNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| VOCAL CORD DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ALOPECIA AREATA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC PIGMENTED PURPURA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| CUTANEOUS LUPUS ERYTHEMATOSUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS BULLOUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| GRANULOMA SKIN | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| GUTTATE PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HENOCH-SCHONLEIN PURPURA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERSENSITIVITY VASCULITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERTRIGO | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| LICHEN PLANUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| LICHEN SCLEROSUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PALMOPLANTAR KERATODERMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PURPURA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PYODERMA GANGRENOSUM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH VESICULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ROSACEA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SEBORRHOEIC DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN IRRITATION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN MASS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN PLAQUE | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN REACTION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN TOXICITY | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TONSILLECTOMY | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| VASCULITIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
|
| Change from Baseline to Month 48 (N=969) |
|
| Change from Baseline to Month 60 (N=837) |
|
| Change from Baseline to Month 72 (N=748) |
|
|
| Change from Baseline to Month 48 (N=2403) |
|
| Change from Baseline to Month 60 (N=2162) |
|
| Change from Baseline to Month 72 (N=1983) |
|
|
| Change from Baseline to Month 48 (N=436) |
|
| Change from Baseline to Month 60 (N=368) |
|
| Change from Baseline to Month 72 (N=303) |
|
|
| Change from Baseline to Month 48 (N=493) |
|
| Change from Baseline to Month 60 (N=418) |
|
| Change from Baseline to Month 72 (N=361) |
|
|
| Change from Baseline to Month 48 (N=435) |
|
| Change from Baseline to Month 60 (N=365) |
|
| Change from Baseline to Month 72 (N=300) |
|
|
| Change from Baseline to Month 48 (N=944) |
|
| Change from Baseline to Month 60 (N=817) |
|
| Change from Baseline to Month 72 (N=718) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (N=1003) |
|
| Month 48 (N=869) |
|
| Month 60 (N=798) |
|
| Month 72 (N=711) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (N=134) |
|
| Month 48 (N=131) |
|
| Month 60 (N=124) |
|
| Month 72 (N=97) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (N=229) |
|
| Month 48 (N=180) |
|
| Month 60 (N=197) |
|
| Month 72 (N=180) |
|
| Title | Measurements |
|---|---|
|
| Month 36 (N=229) |
|
| Month 48 (N=180) |
|
| Month 60 (N=195) |
|
| Month 72 (N=180) |
|