Adverse Events Module

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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 @ 2:19 AM
Ignite Modification Date: 2025-12-26 @ 12:50 AM
NCT ID: NCT01505634
Description: AEs were reported for the All Participants as Treated Population that included all randomized participants who received ≥ 1 dose of study treatment. All-Cause Mortality included deaths outside the 14 day follow up period.
Frequency Threshold: 5
Time Frame: Up to 42 days following completion of all study therapy for drug-related serious adverse events (up to 56 days); and up to 14 days following completion of all study therapy for all-cause serious and non-serious adverse events (up to 28 days).
Study: NCT01505634
Study Brief: Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Relebactam 250 mg With Imipenem/Cilastatin Relebactam 250 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days. 2 None 5 99 11 99 View
Relebactam 125 mg With Imipenem/Cilastatin Relebactam 125 mg IV co-administered with 500 mg of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days. 0 None 2 99 9 99 View
Relebactam Placebo With Imipenem/Cilastatin Matching placebo for relebactam (0.9% normal saline) IV co-administered with 500 mg dose of imipenem/cilastatin once every 6 hours for a minimum of 96 hours. After 96 hours of IV treatment, participants may be switched to 500 mg ciprofloxacin (as optional oral therapy following minimum duration of IV study drug), administered orally, twice daily for the remainder of the study. Antibiotic therapy (IV and oral combined) should not exceed 14 days. 0 None 3 100 7 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Glomerulonephritis rapidly progressive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Renal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View