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 @ 1:42 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
NCT ID:
NCT02068495
Description:
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Participants may be represented in more than 1 category.
Frequency Threshold:
0.3
Time Frame:
Up to 12 Months
Study:
NCT02068495
Study Brief:
Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Candesartan Cilexetil/Amlodipine | Candesartan cilexetil/Amlodipine 8 mg/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. | None | None | 63 | 3300 | 97 | 3300 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Bile duct cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Plasma cell myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Liver carcinoma ruptured | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Marasmus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Motor neurone disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Myocardial ischaemial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Diverticulitis intestinal haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Renal artery stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Renal disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Pubis fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |