Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B7A-MC-MBCM | Other Identifier | Eli Lilly and Company |
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
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruboxistaurin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ruboxistaurin | Drug | 32-mg tablet, orally, daily, up to 42 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100. | Baseline through 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karl Beutner | Chromaderm, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT -5 hours, EST) or speak with your personal physician. | Indianapolis | Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18708615 | Derived | Davis MD, Sheetz MJ, Aiello LP, Milton RC, Danis RP, Zhi X, Girach A, Jimenez MC, Vignati L; PKC-DRS2 Study Group. Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):1-4. doi: 10.1167/iovs.08-2473. Epub 2008 Aug 15. |
Not provided
Not provided
This study consisted of a 36-month treatment phase and a 0 to 6-month extended treatment phase. Completers are those who completed the 36-month treatment phase.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ruboxistaurin | One 32-milligram (mg) tablet, orally, daily, for up to 42 months |
| FG001 | Placebo | 1 tablet, orally, daily, for up to 42 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ruboxistaurin | One 32-mg tablet, orally, daily, for up to 42 months |
| BG001 | Placebo | 1 tablet, orally, daily, for up to 42 months |
| 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 | Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period | SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100. | All randomized participants. | Posted | Number | percentage of participants | Baseline through 36 months |
|
Not provided
Not provided
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 | Ruboxistaurin | One 32-mg tablet, orally, daily, for up to 42 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| info@chroma-derm.com | Chromaderm | info@chroma-derm.com |
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C099154 | ruboxistaurin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | 1 tablet, orally, daily, up to 42 months |
|
| Baseline through 36 months |
| Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100. | Baseline through 36 months |
| Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome). | Baseline, up to 36 months |
| Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health. | Baseline, up to 36 months |
| United States |
| Death |
|
| Adverse Event |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
One 32-mg tablet, orally, daily, for 36 months |
| OG001 | Placebo | 1 tablet, orally, daily, for 36 months |
|
|
|
| Secondary | Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) | DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100. | All randomized participants who had no center involved or imminently threatened DME at baseline. | Posted | Number | percentage of participants | Baseline through 36 months |
|
|
|
| Secondary | Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) | Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100. | All randomized participants. | Posted | Number | percentage of participants | Baseline through 36 months |
|
|
|
| Secondary | Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) | NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome). | All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, up to 36 months |
|
|
|
| Secondary | Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire | SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health. | All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values | Posted | Mean | Standard Deviation | units on a scale | Baseline, up to 36 months |
|
|
|
| 145 |
| 345 |
| 314 |
| 345 |
| EG001 | Placebo | 1 tablet, orally, daily, for up to 42 months | 157 | 340 | 322 | 340 |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Aortic valve disease mixed | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cor pulmonale chronic | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Coronary artery atherosclerosis | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Coronary artery insufficiency | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Torsade de pointes | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Inner ear disorder | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Endophthalmitis | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Retinal neovascularisation | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Coeliac disease | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Colonic haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Uvulitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Portal hypertensive gastropathy | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis acute | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Clostridium colitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Fungal cystitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Postoperative infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Septic embolus | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Chemical burn of skin | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Closed head injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Haemothorax | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Lung injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Blood glucose fluctuation | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Coagulation time abnormal | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lower limb deformity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Spinal meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Squamous endometrial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 8.0 | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | MedDRA 8.0 | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA 8.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoperfusion | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Peripheral occlusive disease | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
Not provided
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |