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 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
NCT ID:
NCT01574651
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT01574651
Study Brief:
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol | QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use. | None | None | 30 | 476 | 72 | 476 | View |
| Tiotropium Plus Formoterol and Placebo to QVA149 | Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use. | None | None | 24 | 458 | 79 | 458 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Congestive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cor pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Amblyopia | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Cataract cortical | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Cataract nuclear | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 16.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 16.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Chest injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Cervical spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Osteochondrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | View |
| Oropharyngeal cancer stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | View |
| Brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Inguinal hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 16.0 | View |
| Laryngeal fistula repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 16.0 | View |
| Mastectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 16.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Stress cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Synovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Umbilical hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 16.0 | View |
Other Events(If Any):