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 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
NCT ID:
NCT05645757
Description:
None
Frequency Threshold:
5
Time Frame:
AEs were documented from the time of starting study drug administration through the time of Final Visit (Day 11 + 3 days)
Study:
NCT05645757
Study Brief:
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 7 - WCK 6777 6 g | WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. | 0 | None | 0 | 6 | 4 | 6 | View |
| Placebo | Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort. | 0 | None | 0 | 10 | 9 | 10 | View |
| Cohort 1 - WCK 6777 2 g | WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days. | 0 | None | 0 | 6 | 6 | 6 | View |
| Cohort 2 - ERT 2 g | Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days. | 0 | None | 0 | 6 | 6 | 6 | View |
| Cohort 3 - ZID 2 g | Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 4 - WCK 6777 4 g | WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 5 - ERT 3 g | Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. | 0 | None | 0 | 6 | 4 | 6 | View |
| Cohort 6 - ZID 3 g | Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. | 0 | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Infusion site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site papule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site phlebitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Infusion site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Injection site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Injection site phlebitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Vessel puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Vessel puncture site phlebitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Heart rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Pharyngeal erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Photosensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |