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 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
NCT ID:
NCT04311502
Description:
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017. An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution.
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Frequency Threshold:
0
Time Frame:
From entry through Week 65
Study:
NCT04311502
Study Brief:
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm1 | Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks. Doses (administered orally once daily): rifapentine, 1200mg; isoniazid, 300mg; pyrazinamide, 40 to \<55kg 1000mg, 55to \<71kg 1500mg; ≥71kg 2000mg; ethambutol, 40 to \<55kg 800mg, 55to \<71kg 1200mg; ≥71 kg 1600mg Rifapentine: 1200 mg once daily Isoniazid: 300 mg once daily Pyrazinamide: 1000mg once daily if weight is 40 to \<55kg 1500mg once daily if weight is 55to \<71kg 2000mg once if weight is ≥71kg Ethambutol: 800 mg once daily if weight is 40 to \<55kg 1200 mg once daily if weight is 55 to \<71kg 1600mg once if weight is ≥71kg Clofazimine: 300 mg once daily for 2 weeks (loading dose). 100 mg once daily | 1 | None | 8 | 58 | 25 | 58 | View |
| Arm2 | Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks. Doses (administered orally once daily): rifampicin, 600mg; isoniazid, 300mg; pyrazinamide, 40 to \<55kg 1000mg, 55to \<71kg 1500mg; ≥71 kg 2000mg; ethambutol, 40 to \<55kg 800mg, 55to \<71kg 1200mg; ≥71 kg 1600mg Rifampicin: 600 mg once daily Isoniazid: 300 mg once daily Pyrazinamide: 1000mg once daily if weight is 40 to \<55kg 1500mg once daily if weight is 55to \<71kg 2000mg once if weight is ≥71kg Ethambutol: 800 mg once daily if weight is 40 to \<55kg 1200 mg once daily if weight is 55 to \<71kg 1600mg once if weight is ≥71kg | 1 | None | 2 | 31 | 7 | 31 | View |
| ArmC | Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks). Doses (for on study medications; administered orally once daily): rifapentine, 1200mg; isoniazid, 300mg; pyrazinamide, 40 to \<55kg 1000mg, 55to \<71kg 1500mg; ≥71 kg 2000mg; ethambutol, 40 to \<55kg 800mg, 55to \<71kg 1200mg; ≥71 kg 1600mg Rifapentine: 1200 mg once daily Isoniazid: 300 mg once daily Pyrazinamide: 1000mg once daily if weight is 40 to \<55kg 1500mg once daily if weight is 55to \<71kg 2000mg once if weight is ≥71kg Ethambutol: 800 mg once daily if weight is 40 to \<55kg 1200 mg once daily if weight is 55 to \<71kg 1600mg once if weight is ≥71kg Clofazimine: 300 mg once daily for 2 weeks (loading dose). 100 mg once daily | 1 | None | 2 | 15 | 3 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ocular icterus | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 28.0 | View |
| Cerebral toxoplasmosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Disseminated tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Immune reconstitution inflammatory syndrome associated tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Cor pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 28.0 | View |
| Incarcerated inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 28.0 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 28.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 28.0 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 28.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 28.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 28.0 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 28.0 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 28.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 28.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Scabies | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 28.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 28.0 | View |
| Abnormal loss of weight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 28.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 28.0 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 28.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 28.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 28.0 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 28.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 28.0 | View |