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 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
NCT ID:
NCT00359632
Description:
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
Through and including 28 calendar days after the last administration of the investigational product
Study:
NCT00359632
Study Brief:
Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel. | None | None | 0 | 9 | 1 | 9 | View |
| Linezolid | Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days). | None | None | 6 | 24 | 20 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | None | General disorders | MedDRA v16.1 | View |
| Erythropoiesis abnormal | None | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Sideroblastic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Condition aggravated | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v16.1 | View |
| General physical health deterioration | None | General disorders | MedDRA v16.1 | View |
| Sepsis | None | Infections and infestations | MedDRA v16.1 | View |
| Polyneuropathy | None | Nervous system disorders | MedDRA v16.1 | View |
| Hypertension | None | Vascular disorders | MedDRA v16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Leukopenia | None | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Neutropenia | None | Blood and lymphatic system disorders | MedDRA v16.1 | View |
| Diabetic retinal oedema | None | Eye disorders | MedDRA v16.1 | View |
| Narrow anterior chamber angle | None | Eye disorders | MedDRA v16.1 | View |
| Optic neuropathy | None | Eye disorders | MedDRA v16.1 | View |
| Retinal disorder | None | Eye disorders | MedDRA v16.1 | View |
| Toxic optic neuropathy | None | Eye disorders | MedDRA v16.1 | View |
| Visual impairment | None | Eye disorders | MedDRA v16.1 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Gastrointestinal disorder | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Tooth discolouration | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA v16.1 | View |
| Asthenia | None | General disorders | MedDRA v16.1 | View |
| Chest pain | None | General disorders | MedDRA v16.1 | View |
| Fatigue | None | General disorders | MedDRA v16.1 | View |
| Malaise | None | General disorders | MedDRA v16.1 | View |
| Oedema peripheral | None | General disorders | MedDRA v16.1 | View |
| Folliculitis | None | Infections and infestations | MedDRA v16.1 | View |
| Oral candidiasis | None | Infections and infestations | MedDRA v16.1 | View |
| Vulvovaginal mycotic infection | None | Infections and infestations | MedDRA v16.1 | View |
| Complications of transplant surgery | None | Injury, poisoning and procedural complications | MedDRA v16.1 | View |
| Blood lactic acid increased | None | Investigations | MedDRA v16.1 | View |
| Haemoglobin decreased | None | Investigations | MedDRA v16.1 | View |
| Hepatic enzyme increased | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Platelet count increased | None | Investigations | MedDRA v16.1 | View |
| Protein total increased | None | Investigations | MedDRA v16.1 | View |
| Vitamin B1 decreased | None | Investigations | MedDRA v16.1 | View |
| Vitamin B12 decreased | None | Investigations | MedDRA v16.1 | View |
| Weight decreased | None | Investigations | MedDRA v16.1 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Folate deficiency | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Hyperkalaemia | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Malnutrition | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Vitamin B1 deficiency | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Vitamin B12 deficiency | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Vitamin B6 deficiency | None | Metabolism and nutrition disorders | MedDRA v16.1 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA v16.1 | View |
| Headache | None | Nervous system disorders | MedDRA v16.1 | View |
| Neuropathy peripheral | None | Nervous system disorders | MedDRA v16.1 | View |
| Paraesthesia | None | Nervous system disorders | MedDRA v16.1 | View |
| Polyneuropathy | None | Nervous system disorders | MedDRA v16.1 | View |
| Sinus headache | None | Nervous system disorders | MedDRA v16.1 | View |
| Somnolence | None | Nervous system disorders | MedDRA v16.1 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | View |