Comparison · NCT04983901-sae
Imipenem-Relebactam Arm vs Group II (Cefepime, Meropenem, Piperacillin/Tazobactam): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Imipenem-Relebactam Arm vs Group II (Cefepime, Meropenem, Piperacillin/Tazobactam): serious adverse events. Trial comparisons, record NCT04983901-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04983901-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.612 | 0.472 | 0.736 | wilson | |
| Risk in group 2 | 0.58 | 0.442 | 0.706 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0322 | -0.156 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.763 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.512 | 2.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Imipenem-Relebactam Arm than on Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | 31 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | 30 | 49 | EG000 |
| Group 2 | Group II (Cefepime, Meropenem, Piperacillin/Tazobactam) | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. | 29 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of the start of inpatient IV study drug to 35 to 42 days after the start of inpatient IV study drug
Source ClinicalTrials.gov
Trial
- Title
- PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
- NCT number
- NCT04983901
- Phases
- PHASE2
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Interventions
- Imipenem/Cilastatin/Relebactam, Cefepime, Meropenem, Piperacillin-Tazobactam, Vancomycin, Daptomycin, Linezolid
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2024-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04983901?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04983901-sae