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 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT02821832
Description:
None
Frequency Threshold:
5
Time Frame:
72 weeks
Study:
NCT02821832
Study Brief:
Using Biomarkers to Predict TB Treatment Duration
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A | Expected high risk of relapse based on radiographic criteria, bacterial load criterion, and/or adherence criterion standard of care treatment for 6 months: 2 months Isoniazid, Rifampicin, Pyrazinamide and Ethambutol + 4 months Isoniazid, Rifampicin | 4 | None | 20 | 251 | 0 | 251 | View |
| Arm B | Expected low risk of relapse based on radiographic criteria, bacterial load criterion, and/or adherence criterion standard of care treatment for 6 months: 2 months Isoniazid, Rifampicin, Pyrazinamide and Ethambutol + 4 months Isoniazid, Rifampicin | 3 | None | 5 | 154 | 0 | 154 | View |
| Arm C | Expected low risk of relapse based on radiographic criteria, bacterial load criterion, and/or adherence criterion shortened treatment: 2 months Isoniazid, Rifampicin, Pyrazinamide and Ethambutol + 2 months Isoniazid, Rifampicin | 0 | None | 3 | 141 | 0 | 141 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Alcoholic pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Bartholin's cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cor pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Foetal death | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gunshot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Head trauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Leg amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumothorax traumatic | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Stab wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Stillbirth | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Urethral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):