Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
NCT ID:
NCT02539368
Description:
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Frequency Threshold:
0
Time Frame:
From baseline to follow-up period (up to a maximum duration of 2 years)
Study:
NCT02539368
Study Brief:
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CT-P13 | Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. | 4 | None | 256 | 1522 | 442 | 1522 | View |
| Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. | 2 | None | 43 | 494 | 100 | 494 | View |
| Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. | 1 | None | 57 | 358 | 90 | 358 | View |
| Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. | 0 | None | 10 | 67 | 7 | 67 | View |
| Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. | 0 | None | 15 | 102 | 21 | 102 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Bicytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Cardiovascular disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Adrenocorticotropic hormone deficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v21.1 | View |
| Steroid withdrawal syndrome | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v21.1 | View |
| Thyroid mass | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v21.1 | View |
| Abdominal incarcerated hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Anal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Diarrhoea haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Diverticulum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Duodenal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Duodenitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Enterocutaneous fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Fistula of small intestine | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Gastrointestinal anastomotic stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Ileal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Ileal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Inflammatory bowel disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Large intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Malabsorption | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Obstruction gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Pancreatitis chronic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Peptic ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Small intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Adhesion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Administration site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Alcohol withdrawal syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Condition aggravated | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Multiple organ dysfunction syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Paradoxical drug reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Stenosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholangitis sclerosing | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Hepatitis cholestatic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Hepatocellular injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Lupus hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Sarcoidosis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Type I hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Abscess intestinal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Anal fistula infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Beta haemolytic streptococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Biliary sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Brain abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Breast abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Chronic tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cryptosporidiosis infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cytomegalovirus colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cytomegalovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Disseminated tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Epstein-Barr virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Escherichia urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Febrile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Hepatitis C | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Infected fistula | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Liver abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Measles | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pneumonia influenzal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pneumonia legionella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Post procedural infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Post procedural sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Rotavirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Subdiaphragmatic abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Anastomotic fistula | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Anastomotic ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Gastrointestinal stoma complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Incisional hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Ligament rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Maternal exposure during pregnancy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Post procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| CSF pressure | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Drug specific antibody present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v21.1 | View |
| Angiomyolipoma | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Ankylosing spondylitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Arthritis enteropathic | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Fistula | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Intervertebral disc disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Muscle rupture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Sarcopenia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Spondylitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Breast cancer in situ | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Chronic lymphocytic leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Gastrointestinal stromal tumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Intraductal proliferative breast lesion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Invasive ductal breast carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Seminoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Tongue neoplasm malignant stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Meningioma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Migraine with aura | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | View |
| Foetal death | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Psychiatric decompensation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Schizophrenia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Kidney congestion | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Nephrotic syndrome | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Tubulointerstitial nephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Female genital tract fistula | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Uterine polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Alveolitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Pulmonary mass | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Respiratory symptom | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Cutaneous vasculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dermatitis psoriasiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Hidradenitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Palmoplantar pustulosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Caesarean section | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v21.1 | View |
| Colectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v21.1 | View |
| Ventriculo-peritoneal shunt | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v21.1 | View |
| Aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Aortic aneurysm rupture | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Behcet's syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Circulatory collapse | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Femoral artery embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Poor venous access | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Vasculitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Microcytic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Abdominal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Lung adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Bladder disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| IgA nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Fibrocystic breast disease | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Gynaecomastia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Ovarian cyst torsion | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Pustular psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Pyoderma gangrenosum | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v21.1 | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Cardiovascular insufficiency | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v21.1 | View |
| Neurosensory hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v21.1 | View |
| Thyroiditis | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v21.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v21.1 | View |
| Retinal vein occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v21.1 | View |
| Scleritis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v21.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v21.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Abdominal tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Anal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Gastrointestinal anastomotic stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Gastrointestinal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Large intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Obstruction gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Pancreatic failure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Pouchitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Dysplasia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Feeling abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Fibrosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Unevaluable event | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Autoimmune hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Cholestasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Hepatocellular injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Non-alcoholic steatohepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v21.1 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Serum sickness | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Type I hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v21.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Gastrointestinal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Genital herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Genital herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Groin abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Herpes virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Latent tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Nail infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Ophthalmic herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Opportunistic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Oral fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Parvovirus B19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pertussis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tinea cruris | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tinea versicolour | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Ureteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Varicella zoster virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Vulval abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Vulvovaginal mycotic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Exposure to communicable disease | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Maternal exposure during pregnancy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Medication error | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Suture related complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Blood count abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Colonoscopy | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Drug specific antibody present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Cell death | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v21.1 | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v21.1 | View |
| Vitamin B12 deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v21.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Lupus-like syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Malignant melanoma in situ | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Malignant melanoma stage III | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Skin cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Facial paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Meningioma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | View |
| Gestational trophoblastic detachment | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | View |
| Abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Nasal discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Actinic keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Drug eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dyshidrotic eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Erythema nodosum | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Hidradenitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Rebound psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Abortion induced | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v21.1 | View |
| Intestinal resection | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v21.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Ileal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Anal fistula infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Campylobacter gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Papilloma viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Mean cell volume decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Demyelination | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v21.1 | View |
| Dermatitis atopic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Dermatitis psoriasiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Poor venous access | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v21.1 | View |
| Demyelinating polyneuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |