| Primary | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| | | Title | Denominators | Categories |
|---|
| Symptomatic resolution | | | | Symptom persistence | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin | Unstratified Miettinen & Nurminen method | | | | Difference of symp resolution rates | 4.0 | | | 2-Sided | 95 | -2.39 | 10.42 | | | | | Non-Inferiority or Equivalence | | |
|
| Primary | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Primary | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV)) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Number of patients with a favorable per patient microbiological response at TOC | Microbiological evaluable analysis set at TOC (ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | Microbiological evaluable analysis set at LFU (ME at LFU) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Number of patients with a favorable per-patient microbiological response at EOT (IV) | Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV)) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Number of patients with a favorable per patient microbiological response at TOC | Extended microbiological evaluable analysis set at TOC (Extended ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Number of patients with a favorable per patient microbiological response at LFU | Extended microbiological evaluable analysis set at LFU (Extended ME at LFU) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV)) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological evaluable analysis set at TOC (ME at TOC ) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Microbiological evaluable analysis set at LFU (ME at LFU) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV)) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Extended microbiological evaluable analysis set at TOC (Extended ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Extended microbiological evaluable analysis set at LFU (Extended ME at LFU) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV)) | Posted | | Number | | Participants | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Clinically evaluable analysis set at TOC (CE at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. | Clinically evaluable analysis set at LFU (CE at LFU) | Posted | | Number | | Participants | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | Microbiological evaluable analysis set at TOC(ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. | Extended microbiological evaluable analysis set at TOC(Extended ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. | Microbiological evaluable analysis set at TOC(ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. | Extended microbiological evaluable analysis set at TOC(Extended ME at TOC) | Posted | | Number | | Participants | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participants | | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. | Microbiological evaluable analysis set at TOC(ME at TOC) | Posted | | Number | | Participants | | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. | Extended microbiological evaluable analysis set at TOC(Extended ME at TOC) | Posted | | Number | | Participants | | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. | Clinically evaluable analysis set at TOC(CE at TOC) | Posted | | Number | | Participants | | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set | Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV)) | Posted | | Number | | Participant | | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set | Extended microbiological evaluable analysis set at TOC (EME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set | Extended microbiological evaluable analysis set at LFU (EME at LFU) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set | Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV)) | Posted | | Number | | Participant | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set | Microbiological evaluable analysis set at TOC (ME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set | Microbiological evaluable analysis set at LFU (ME at LFU) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only | Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV)) | Posted | | Number | | Participant | | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only | Extended microbiological evaluable analysis set at TOC (EME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only | Extended microbiological evaluable analysis set at LFU (EME at LFU) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only | Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV)) | Posted | | Number | | Participant | | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only | Microbiological evaluable analysis set at TOC (ME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only | Microbiological evaluable analysis set at LFU (ME at LFU) | Posted | | Number | | Participant | | At LFU visit. LFU visit is 45 to 52 days from Randomization. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set | Extended microbiological evaluable analysis set at TOC (EME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set | Microbiological evaluable analysis set at TOC (ME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set | Microbiological modified intent to treat analysis set (mMITT) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set | Extended microbiological evaluable analysis set at TOC (EME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set | Microbiological evaluable analysis set at TOC (ME at TOC) | Posted | | Number | | Participant | | At TOC visit. TOC visit is 21 to 25 days from Randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group | | OG001 | Doripenem | Doripenem treatment group |
| |
| Secondary | Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (ceftazidime within 15 minutes before/after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | within 15 minutes before/after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |
| Secondary | Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (ceftazidime between 30 to 90 minutes after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | Between 30 to 90 minutes after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |
| Secondary | Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (ceftazidime between 300 to 360 minutes after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | Between 300 to 360 minutes after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |
| Secondary | Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (avibactam within 15 minutes before/after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | within 15 minutes before/after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |
| Secondary | Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (avibactam between 30 to 90 minutes after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | Between 30 to 90 minutes after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |
| Secondary | Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. | PK analysis set (avibactam between 300 to 360 minutes after dose) | Posted | | Geometric Mean | Full Range | NG/ML | | Between 300 to 360 minutes after dose | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | Ceftazidime-avibactam treatment group |
| | |