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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
NCT ID:
NCT00876733
Description:
None
Frequency Threshold:
5
Time Frame:
36 months
Study:
NCT00876733
Study Brief:
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. | None | None | 12 | 203 | 33 | 203 | View |
| Patients With Baseline Viral Load Not Documented | Patients who could not be assigned to one of the three subgroups and had no documented viral load value. | None | None | 0 | 21 | 3 | 21 | View |
| Treatment-naive Patients | Patients who were not pretreated with HIV therapy. | None | None | 17 | 288 | 51 | 288 | View |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL. | None | None | 5 | 93 | 22 | 93 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Somatoform disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Laser therapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 17.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 17.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Meningoencephalitis herpetic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Myelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Biopsy | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Hepatic enzyme abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Juvenile idiopathic arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Anogenital warts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Hypopharyngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Hypopharyngeal cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Abortion incomplete | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MEDDRA 17.0 | View |
| Acute stress disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Alcoholism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Acute prerenal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 17.0 | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 17.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 17.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Bursa removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 17.0 | View |
| Laparoscopic surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 17.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Transaminase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 17.0 | View |