Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV) |
Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required. |
Within 72 hours after administration of the last dose of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV. |
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV. |
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC |
The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU) |
The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC) |
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU) |
The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC |
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU. |
The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. |
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Within 72 hours after administration of the last dose of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Clinical Response in the ME Analysis Set at TOC |
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Clinical Response in the ME Analysis Set at LFU. |
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at EOIV. |
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Within 72 hours after administration of the last dose of inpatient IV study drug |
|
Secondary |
Favorable Microbiological Response in the mMITT Analysis Set at TOC. |
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at LFU. |
The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug. |
|
Secondary |
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at EOIV. |
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
Within 72 hours after administration of the last dose of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at TOC. |
The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU |
The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Infection-related Mortality in the MITT Analysis Set at TOC |
The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Infection-related Mortality in the MITT Analysis Set at LFU |
The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC |
The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). |
21 to 28 days after the start of inpatient IV study drug |
|
Secondary |
Number of Participants With Infection-related Mortality in the mMITT Analysis Set at LFU. |
The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). |
35 to 42 days after the start of inpatient IV study drug |
|
Secondary |
30 Day All-cause Mortality in the MITT Analysis Set |
The secondary efficacy outcome is all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. |
30 days after the last dose of inpatient IV study drug |
|
Secondary |
30 Day All-cause Mortality in the mMITT Analysis Set |
The secondary efficacy outcome is all-cause mortality of the patients in the mMITT (microbiological Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug. |
30 days after the last dose of inpatient IV study drug |
|