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 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
NCT ID:
NCT00447902
Description:
None
Frequency Threshold:
5
Time Frame:
Screening through the duration of the trial (Week 48 planned).
Study:
NCT00447902
Study Brief:
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard of Care | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules | None | None | 1 | 4 | 3 | 4 | View |
| Therapeutic Drug Monitoring | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules | None | None | 2 | 6 | 2 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| cardio respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 11.1 WHO-DD | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 11.1 WHO-DD | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 11.1 WHO-DD | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 11.1 WHO-DD | View |
| hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 11.1 WHO-DD | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 11.1 WHO-DD | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 11.1 WHO-DD | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 11.1 WHO-DD | View |
| vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 11.1 WHO-DD | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 11.1 WHO-DD | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 11.1 WHO-DD | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 11.1 WHO-DD | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 11.1 WHO-DD | View |
| muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 11.1 WHO-DD | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 11.1 WHO-DD | View |
| adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| injection site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 11.1 WHO-DD | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 11.1 WHO-DD | View |
| blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 11.1 WHO-DD | View |
| haemoglobin decrease | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 11.1 WHO-DD | View |
| Skin nodules | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 11.1 WHO-DD | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 11.1 WHO-DD | View |
| oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 11.1 WHO-DD | View |