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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
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This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).
This is a prospective, observational, post-marketing safety surveillance registry of UC participants treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 participants (1000 Remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. Participants who started the registry on standard therapy may switch over to Remicade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade Group | Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion. |
| |
| Standard Therapy Group | Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab | Biological | The treating physician will determine the treatment regimen and dose of Remicade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities. | Up to 5 years. |
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Inclusion Criteria:
18 years of age, of either sex, and of any race.
Moderate-to-severe active UC, as defined by assessment by the treating physician.
Must, within 30 days of Baseline, either:
Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.
Exclusion Criteria:
In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.
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Adult participants, ages 18 years and older, with a diagnosis of moderate-to-severe active UC will be eligible to enroll in the registry.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30809631 | Derived | Panes J, Lindsay JO, Teich N, Lindgren S, Colombel JF, Cornillie F, Flynn HA, Huyck S, Stryszak P, Yao R, Philip G, Reinisch W. Five-year Safety Data From OPUS, a European Observational Safety Registry for Adults With Ulcerative Colitis Treated With Originator Infliximab [Remicade(R)] or Conventional Therapy. J Crohns Colitis. 2019 Sep 19;13(9):1148-1157. doi: 10.1093/ecco-jcc/jjz048. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remicade Group | Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion. |
| FG001 | Standard Therapy Group | Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for Ulcerative Colitis (UC) or any other condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remicade Group | Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion. |
| 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 Within Each of Nine Pre-specified Adverse Event (AE) Categories | The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities. | All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade. | Posted | Number | Percentage of participants | Up to 5 years. |
Up to 5 years
All enrolled participants.The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remicade Group | Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Standard Therapy | Drug | The standard therapy group will consist of participants receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy participant will be left to the discretion of the treating physician and may change during the course of a participant's participation in the registry. |
|
| Withdrawal by Subject |
|
| Administrative |
|
| BG001 | Standard Therapy Group | Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 439 |
| 1,059 |
| 321 |
| 1,059 |
| EG001 | Standard Therapy Group | Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition. | 294 | 1,180 | 173 | 1,180 |
| EG002 | Switched to Remicade Group | Participants who started in the Standard Therapy Group but switched over to Remicade. AEs were counted after the switch to Remicade. | 102 | 296 | 70 | 296 |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bone Marrow Failure | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Immune Thrombocytopenic Purpura | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Normochromic Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Aortic Valve Incompetence | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Heart Valve Incompetence | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Prinzmetal Angina | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sinus Node Dysfunction | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Meniere's Disease | Ear and labyrinth disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Basedow's Disease | Endocrine disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Conjunctivitis Allergic | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Corneal Scar | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Endocrine Ophthalmopathy | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Eye Disorder | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Hernia Obstructive | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Wall Haematoma | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Abdomen | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Incontinence | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Stenosis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Ulcer | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anorectal Discomfort | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anorectal Disorder | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Colon Dysplasia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Diarrhoea Haemorrhagic | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Diverticular Perforation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Enterocolitis Haemorrhagic | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Eosinophilic Oesophagitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastric Atony | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastric Polyps | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Dysplasia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Polyp Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemorrhoids Thrombosed | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ileal Stenosis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Inflammatory Bowel Disease | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Dilatation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Perforation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Stenosis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intra-Abdominal Fluid Collection | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intra-Abdominal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Jejunal Perforation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Large Intestinal Stenosis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Megacolon | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Mesenteric Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Oedematous Pancreatitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Oesophageal Food Impaction | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Peritoneal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pouchitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Lesion | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Prolapse | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Stenosis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Small Intestinal Perforation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Catheter Site Inflammation | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Drug Ineffective | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Drug Intolerance | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dysplasia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gait Disturbance | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Obstruction | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Strangulated Hernia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sudden Death | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Surgical Failure | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Treatment Failure | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Vascular Stent Restenosis | General disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Autoimmune Hepatitis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholangitis Acute | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholangitis Sclerosing | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholestasis Of Pregnancy | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Drug-Induced Liver Injury | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hepatitis Cholestatic | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hepatitis Toxic | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Liver Injury | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Portal Vein Thrombosis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Serum Sickness | Immune system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominal Wall Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Abscess Jaw | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Acinetobacter Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Anal Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Arthritis Bacterial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Atypical Pneumonia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Bartholinitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Biliary Sepsis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Breast Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Campylobacter Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Candida Endophthalmitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Candida Sepsis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Clostridial Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Clostridium Difficile Colitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cytomegalovirus Colitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Device Related Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Eczema Infected | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Encephalitis Cytomegalovirus | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Enterococcal Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Escherichia Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Gallbladder Empyema | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastroenteritis Clostridial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Incision Site Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Infectious Mononucleosis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Keratitis Bacterial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Klebsiella Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Listeria Sepsis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Lung Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Meningitis Viral | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Perineal Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pilonidal Cyst | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumonia Escherichia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumonia Legionella | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Post Procedural Sepsis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Postoperative Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Proctitis Infectious | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pulmonary Tuberculosis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Purulent Discharge | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyelitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Relapsing Fever | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Respiratory Moniliasis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Retinitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Rotavirus Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Pelvic Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Streptococcal Bacteraemia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Tick-Borne Viral Encephalitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Tonsillitis Streptococcal | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Tubo-Ovarian Abscess | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Tularaemia | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Wound Infection Bacterial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Anastomotic Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Anastomotic Fistula | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Anastomotic Stenosis | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Decompression Sickness | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Intestinal Anastomosis Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Open Globe Injury | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumothorax Traumatic | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Post Procedural Diarrhoea | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Post Procedural Inflammation | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Postoperative Hernia | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Scar | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Stoma Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Stoma Site Discomfort | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Stoma Site Inflammation | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Stomal Hernia | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Wound Evisceration | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
|
| Biopsy Lymph Gland | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Blood Magnesium Decreased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Blood Parathyroid Hormone Increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Clostridium Test Positive | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cytomegalovirus Test Positive | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Endobronchial Ultrasound | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Foetal Heart Rate Abnormal | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ankylosing Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Connective Tissue Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dupuytren's Contracture | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Lupus-Like Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Morphoea | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Osteoporotic Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Spinal Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Clear Cell Sarcoma Of Soft Tissue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Colon Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Lung Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Metastases To Bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Metastases To Large Intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Rectal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Small Cell Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Vaginal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Central Nervous System Lesion | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cerebellar Infarction | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cerebellar Syndrome | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Gliosis | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Optic Neuritis | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyramidal Tract Syndrome | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Quadriparesis | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Trigeminal Neuralgia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Foetal Death | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemorrhage In Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Labour Complication | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Labour Pain | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Placenta Praevia Haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Psychosis | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Eating Disorder | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Major Depression | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Mental Fatigue | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Prerenal Failure | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bladder Diverticulum | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bladder Neck Obstruction | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Calculus Bladder | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Renal Infarct | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Tubulointerstitial Nephritis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ureteric Stenosis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Urethral Stenosis | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Noninfective Oophoritis | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Perineal Fistula | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Scrotal Mass | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Vaginal Fistula | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bronchial Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Lung Consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pulmonary Sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Tonsillar Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Dermatitis Bullous | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Lentigo | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pyoderma Gangrenosum | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Solar Lentigo | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Abdominoplasty | Surgical and medical procedures | MedDRA Version 19.1 | Systematic Assessment |
|
| Colectomy | Surgical and medical procedures | MedDRA Version 19.1 | Systematic Assessment |
|
| Female Sterilisation | Surgical and medical procedures | MedDRA Version 19.1 | Systematic Assessment |
|
| Ileostomy | Surgical and medical procedures | MedDRA Version 19.1 | Systematic Assessment |
|
| Ileostomy Closure | Surgical and medical procedures | MedDRA Version 19.1 | Systematic Assessment |
|
| Aortic Stenosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Circulatory Collapse | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Embolism Arterial | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Iliac Artery Occlusion | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Pelvic Venous Thrombosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Peripheral Ischaemia | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Peripheral Vascular Disorder | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Shock Haemorrhagic | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Subclavian Vein Thrombosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Temporal Arteritis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Venous Thrombosis | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |