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 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
NCT ID:
NCT01864603
Description:
This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Frequency Threshold:
0
Time Frame:
Phase I: 3 years Phase II: 3 years
Study:
NCT01864603
Study Brief:
Sustainable East Africa Research in Community Health
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention Arm Stage 1 | Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care Adverse events monitored among persons initiating ART outside of National guidelines | 1217 | None | 89 | 1671 | 80 | 1671 | View |
| Intervention Arm Stage II | Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP Adverse events monitored among persons initiating PrEP | 18 | None | 50 | 5447 | 17 | 5447 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | DAIDS Vers Nov 2014 | View |
| Altered Mental Status | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS Nov 2014 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NIH DAIDS Nov 2014 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NIH DAIDS Nov 2014 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | View |
| Cutaneous Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NIH DAIDS Nov 2014 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Elevated AST | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Elevated Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | View |
| Genital Ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | NIH DAIDS Nov 2014 | View |
| Hemoptysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Intoxication | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Neuromuscular weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Pre-term Labor | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Soft Tissue Injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | View |
| Spontaneous Abortion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Temperature | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Unintentional Weight Loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NIH DAIDS Nov 2014 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| UTI | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | View |
| Wound | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Fetal Demise | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Blood clot in brain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Cesarean Infant Delivery | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Uterine Fibroids | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | DAIDS Vers Nov 2014 | View |
| Injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Pulmonary Tuberculosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | View |
| Ruptured Ectopic Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | NIH DAIDS Nov 2014 | View |
| Seroconversion | SYSTEMATIC_ASSESSMENT | Infections and infestations | NIH DAIDS Nov 2014 | View |
| Stillbirth | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Uterine Prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NIH DAIDS Nov 2014 | View |
| Typhoid | SYSTEMATIC_ASSESSMENT | Infections and infestations | NIH DAIDS Nov 2014 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Altered Mental Status | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | DAIDS Vers Nov 2014 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS Vers Nov 2014 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NIH DAIDS Nov 2014 | View |
| Eye Discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | NIH DAIDS Nov 2014 | View |
| Elevated AST | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Elevated Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Gynaecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NIH DAIDS Nov 2014 | View |
| Leucopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS Nov 2014 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | DAIDS Vers Nov 2014 | View |
| Uterine Bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | DAIDS Vers Nov 2014 | View |
| Stillbirth | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Dizzinesss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS Nov 2014 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | DAIDS Vers Nov 2014 | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NIH DAIDS Nov 2014 | View |
| Spontaneous Abortion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | View |
| Unintentional Weight Loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NIH DAIDS Nov 2014 | View |
| Elevated Bilirubin | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS Nov 2014 | View |