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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
NCT ID:
NCT02453594
Description:
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Frequency Threshold:
5
Time Frame:
Up to approximately 99 months.
Study:
NCT02453594
Study Brief:
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 (First Course) | Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. | 21 | None | 15 | 69 | 68 | 69 | View |
| Cohort 2 (First Course) | Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. | 28 | None | 18 | 81 | 76 | 81 | View |
| Cohort 3 (First Course) | Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment. | 19 | None | 15 | 60 | 56 | 60 | View |
| Cohort 1 (Second Course) | Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year. | 2 | None | 0 | 10 | 10 | 10 | View |
| Cohort 2 (Second Course) | Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year. | 0 | None | 1 | 7 | 7 | 7 | View |
| Cohort 3 (Second Course) | Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year. | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Stress cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Alcoholic pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Acute graft versus host disease | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Myelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Varicella zoster virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Necrotising myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Diffuse large B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Myelodysplastic syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Chronic inflammatory demyelinating polyradiculoneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Ear congestion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.0 | View |
| Iritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Scleral hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Catheter site erosion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscle contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Tumour inflammation | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Tonsillar exudate | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |