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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ceftaroline Fosamil: Young Infants | Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | 0 | None | 0 | 4 | 1 | 4 | View |
| Ceftaroline Fosamil: Term Neonates | Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | 0 | None | 0 | 5 | 3 | 5 | View |
| Ceftaroline Fosamil: Preterm Neonates | Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | 0 | None | 1 | 2 | 1 | 2 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Salmonellosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.0 | View |
| Pyelocaliectasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.0 | View |
| Cerebral cyst | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.0 | View |