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 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
NCT ID:
NCT00108433
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00108433
Study Brief:
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vancomycin/Cefazolin | Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours. | None | None | 3 | 31 | 9 | 31 | View |
| Linezolid | Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days. | None | None | 7 | 30 | 12 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiopulmonary failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Psoas abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Bladder outlet obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Jugular vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Subclavian vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |