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 @ 4:38 PM
Ignite Modification Date:
2025-12-25 @ 2:28 PM
NCT ID:
NCT00865566
Description:
None
Frequency Threshold:
0
Time Frame:
Reporting of all AEs occurred during 2 periods for each participant: 1) from enrollment through 28 days after the third vaccination, and 2) from the fourth vaccination through 28 days after the fourth vaccination. Between and after these time periods, only SAEs, new chronic conditions requiring medical intervention of more than 30 days, and newly diagnosed/treated STIs were reported. Events requiring expedited reporting (protocol section 12.3) were reported through the study, up to 60 months.
Study:
NCT00865566
Study Brief:
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vaccine | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | 1 | None | 77 | 1253 | 833 | 1253 | View |
| Placebo | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid | 11 | None | 95 | 1251 | 828 | 1251 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Anaemias NEC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Ischaemic coronary artery disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Coronary artery disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Heart failures NEC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Supraventricular arrhythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Ventricular arrhythmias and cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 20.1 | View |
| Colitis (excl infective) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Acute and chronic pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Duodenal ulcers and perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Intestinal ulcers and perforation NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal hernias NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastric ulcers and perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal atonic and hypomotility disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal stenosis and obstruction NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Non-site specific gastrointestinal haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Oesophageal ulcers and perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Rectal inflammations NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pain and discomfort NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Death and sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Withdrawal and rebound effects | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Allergies to foods, food additives, drugs and other chemicals | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Abdominal and gastrointestinal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bacterial infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Lower respiratory tract and lung infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Upper respiratory tract infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Clostridia infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Sepsis, bacteraemia, viraemia and fungaemia NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Skin structures and soft tissue infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Staphylococcal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Streptococcal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bone and joint infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Borrelial infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Breast infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Limb fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Skull fractures, facial bone fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Non-site specific injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Overdoses NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Poisoning and toxicity | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Site specific injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Skin injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Spinal fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Abdominal injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Cardiac and vascular procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Cardiovascular injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Cerebral injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Muscle, tendon and ligament injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Pathways and sources of exposure | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Liver function analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Metabolism tests NEC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Potassium imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Bursal disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Intervertebral disc disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle weakness conditions | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Myopathies | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Prostatic neoplasms malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Colorectal neoplasms malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Gastric neoplasms malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Leukaemias acute lymphocytic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Testicular neoplasms malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Seizures and seizure disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Central nervous system haemorrhages and cerebrovascular accidents | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Encephalopathies NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Mononeuropathies | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Neurological signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Optic nerve disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Transient cerebrovascular events | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 20.1 | View |
| Device malfunction events NEC | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Suicidal and self-injurious behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Depressive disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Substance related and addictive disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Bipolar disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Anxiety symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Psychotic disorder NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Confusion and disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Mental disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Schizoaffective and schizophreniform disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Schizophrenia NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Somatic symptom disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pulmonary thrombotic and embolic conditions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pneumothorax and pleural effusions NEC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Skin and subcutaneous tissue ulcerations | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Peripheral embolism and thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Non-site specific necrosis and vascular insufficiency NEC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Vascular hypertensive disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Vascular hypotensive disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Testicular and epididymal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Haemoglobinopathies congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Acute and chronic sarcoidosis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Herpes viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Infectious disorders carrier | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Urinary tract infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Viral infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Thermal burns | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Thyroid neoplasms malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Renal failure and impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Renal lithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Limb fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Site specific injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Neurological and psychiatric procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Bone and joint injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Thermal burns | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Exposures to agents or circumstances NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Anxiety disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Bipolar disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Photosensitivity and photodermatosis conditions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Hearing losses | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Tympanic membrane disorders (excl infections) | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.1 | View |
| Thyroid hypofunction disorders | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.1 | View |
| Endocrine abnormalities of gonadal function NEC | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.1 | View |
| Male gonadal function disorders | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.1 | View |
| Thyroid hyperfunction disorders | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Lid, lash and lacrimal infections, irritations and inflammations | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Ocular disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Conjunctival and corneal bleeding and vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Ocular sensation disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Visual disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Conjunctival infections, irritations and inflammations | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Eyelid movement disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Lacrimation disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Ocular infections, inflammations and associated manifestations | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Blindness (excl colour blindness) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Glaucomas (excl congenital) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Refractive and accommodative disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Retinal, choroid and vitreous infections and inflammations | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Diarrhoea (excl infective) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea and vomiting symptoms | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal and abdominal pains (excl oral and throat) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Stomatitis and ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal atonic and hypomotility disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Haemorrhoids and gastrointestinal varices (excl oesophageal) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Anal and rectal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dental pain and sensation disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dyspeptic signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Intestinal haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastritis (excl infective) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Colitis (excl infective) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Non-site specific gastrointestinal haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal hernias NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Anal and rectal signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dental and periodontal infections and inflammations | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Diaphragmatic hernias | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Flatulence, bloating and distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gingival disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gingival haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Oesophageal ulcers and perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Tongue disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Tongue signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Benign neoplasms gastrointestinal (excl oral cavity) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal inflammatory disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Oral dryness and saliva altered | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal findings abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Anal and rectal pains | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dental disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Faecal abnormalities NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal dyskinetic disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrointestinal fistulae | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Inguinal hernias | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Oral soft tissue pain and paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Peptic ulcers and perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Rectal inflammations NEC | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Injection site reactions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Asthenic conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Febrile disorders | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Feelings and sensations NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| General signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pain and discomfort NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Administration site reactions NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Oedema NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Therapeutic and nontherapeutic responses | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Vaccination site reactions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Mass conditions NEC | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Withdrawal and rebound effects | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Inflammations | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Hepatocellular damage and hepatitis NEC | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Cholecystitis and cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Cholestasis and jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Hepatobiliary signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Atopic disorders | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Allergies to foods, food additives, drugs and other chemicals | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Allergic conditions NEC | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Anaphylactic and anaphylactoid responses | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Upper respiratory tract infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Neisseria infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Viral infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Chlamydial infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Treponema infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Abdominal and gastrointestinal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Herpes viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Streptococcal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Urinary tract infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Lower respiratory tract and lung infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Papilloma viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bacterial infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Eye and eyelid infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Skin structures and soft tissue infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Dental and oral soft tissue infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Ectoparasitic infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Ear infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Staphylococcal infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Tinea infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Influenza viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Male reproductive tract infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Fungal infections NEC | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Hepatitis viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Candida infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Molluscum contagiosum viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Epstein-Barr viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Giardia infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Tuberculous infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Amoebic infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bone and joint infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Caliciviral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Clostridia infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Coxsackie viral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Cytomegaloviral infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Escherichia infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Haemophilus infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Helicobacter infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Nematode infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Skin injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Muscle, tendon and ligament injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Non-site specific injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Non-site specific procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Radiation injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Cerebral injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Fractures and dislocations NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Eye injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Skull fractures, facial bone fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Thoracic cage fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Chest and lung injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Gastrointestinal and hepatobiliary procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Ear injuries NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Overdoses NEC | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Poisoning and toxicity | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Reproductive system and breast injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Spinal fractures and dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Vaccination related complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Vascular tests NEC (incl blood pressure) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Reproductive hormone analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Liver function analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Red blood cell analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Carbohydrate tolerance analyses (incl diabetes) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Digestive enzymes | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Mineral and electrolyte analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Platelet analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Bacteria identification and serology (excl mycobacteria) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Cardiac auscultatory investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Coagulation and bleeding analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Heart rate and pulse investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Investigations NEC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Musculoskeletal and soft tissue tests NEC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Mycobacteria identification and serology | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Tissue enzyme analyses NEC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| White blood cell analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Diabetes mellitus (incl subtypes) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Fat soluble vitamin deficiencies and disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Appetite disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Elevated cholesterol | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Disorders of purine metabolism | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| General nutritional disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Potassium imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Fluid intake increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Food malabsorption and intolerance syndromes (excl sugar intolerance) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Lipid metabolism and deposit disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Water soluble vitamin deficiencies | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Elevated triglycerides | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hyperlipidaemias NEC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypoglycaemic conditions NEC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Magnesium metabolism disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Protein metabolism disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Sugar intolerance (excl glucose intolerance) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Total fluid volume decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Musculoskeletal and connective tissue pain and discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle pains | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Joint related signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle related signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Tendon disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Bone related signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Arthropathies NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Bone disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Bursal disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Intervertebral disc disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle weakness conditions | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle tone abnormalities | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Cartilage disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Extremity deformities | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Joint related disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Musculoskeletal and connective tissue infections and inflammations NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Osteoarthropathies | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Rheumatoid arthropathies | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Soft tissue disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Synovial disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Skin neoplasms benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Lip and oral cavity neoplasms benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Skin neoplasms malignant and unspecified (excl melanoma) | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Soft tissue neoplasms benign NEC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Nervous system neoplasms benign NEC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Reproductive neoplasms male benign NEC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Headaches NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Neurological signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Paraesthesias and dysaesthesias | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Migraine headaches | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Sensory abnormalities NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Disturbances in consciousness NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Mononeuropathies | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Peripheral neuropathies NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Lumbar spinal cord and nerve root disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Narcolepsy and hypersomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Seizures and seizure disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Cervical spinal cord and nerve root disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Coordination and balance disturbances | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Disturbances in sleep phase rhythm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Facial cranial nerve disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Memory loss (excl dementia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Mental impairment (excl dementia and memory loss) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Neurologic visual problems NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Sleep disturbances NEC | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Depressive disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Anxiety symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Disturbances in initiating and maintaining sleep | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Substance related and addictive disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Attention deficit and disruptive behaviour disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Panic attacks and disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Sexual desire disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Stress disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Emotional and mood disturbances NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Schizophrenia NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Behaviour and socialisation disturbances | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Fear symptoms and phobic disorders (incl social phobia) | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Fluctuating mood symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Mental disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Mood alterations with depressive symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Mood disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Schizoaffective and schizophreniform disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Sleep disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Somatic symptom disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Suicidal and self-injurious behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Bladder and urethral symptoms | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Renal lithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Urethral disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Urinary abnormalities | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Urinary tract signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Bladder neoplasms | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Penile disorders NEC (excl erection and ejaculation) | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Reproductive tract signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Erection and ejaculation conditions and disorders | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Prostate and seminal vesicles infections and inflammations | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Reproductive tract disorders NEC (excl neoplasms) | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Testicular and epididymal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Breast signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Scrotal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Breast disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Pelvic prolapse conditions | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Sexual function and fertility disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Spermatogenesis and semen disorders | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Testicular and epididymal neoplasms | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Upper respiratory tract signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Coughing and associated symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Nasal congestion and inflammations | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Paranasal sinus disorders (excl infections and neoplasms) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Bronchospasm and obstruction | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pharyngeal disorders (excl infections and neoplasms) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Breathing abnormalities | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Nasal disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Respiratory tract disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pulmonary oedemas | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Respiratory failures (excl neonatal) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Dermatitis and eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Rashes, eruptions and exanthems NEC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Apocrine and eccrine gland disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Dermal and epidermal conditions NEC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Pruritus NEC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Erythemas | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Psoriatic conditions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Acnes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Angioedemas | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Bullous conditions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Papulosquamous conditions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Pilar disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Purpura and related conditions | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Skin and subcutaneous tissue ulcerations | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Skin cysts and polyps | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Skin preneoplastic conditions NEC | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Alopecias | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Dermatitis ascribed to specific agent | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Hyperkeratoses | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Hyperpigmentation disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Rosaceas | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 20.1 | View |
| Crime victims | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Vascular hypertensive disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Peripheral vascular disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Haemorrhages NEC | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Lymphoedemas | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Peripheral embolism and thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Lymphatic system disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Anaemias NEC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Leukocytoses NEC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Red blood cell abnormal findings NEC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Spleen disorders | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Supraventricular arrhythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Cardiac signs and symptoms NEC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Rate and rhythm disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 20.1 | View |
| Male reproductive tract disorders congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Ear disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Inner ear signs and symptoms | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| External ear disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Middle ear disorders NEC | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Eustachian tube disorders | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Any event in SOC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |