Ceftazidime-Avibactam Compared With Doripenem Followed by... | NCT01595438

NCT01595438

ID	Type	Description	Link
2011-005721-43

Status Module

Name	Class
Forest Laboratories	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ceftazidime - Avibactam ( CAZ-AVI)	Experimental	IV treatment	Drug: Ceftazidime - Avibactam ( CAZ-AVI) Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Doripenem	Active Comparator	IV treatment	Drug: Doripenem Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftazidime - Avibactam ( CAZ-AVI)	Drug	Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)).	At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
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)).	At TOC visit. TOC visit is 21 to 25 days from Randomization.
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.	At TOC visit. TOC visit is 21 to 25 days from Randomization.

Secondary Outcomes

Measure	Description	Time Frame
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)	Number of patients with a favorable per-patient microbiological response at EOT (IV)	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

Eligibility Module

Name	Affiliation	Role
Paul Newell, MBBS, MRCP	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Sylmar	California		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32602065	Derived	Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
30221827	Derived	Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

Results Section

Participant Flow Module

ID	Title	Description
FG000	CAZ-AVI	Ceftazidime-avibactam treatment group
FG001	Doripenem	Doripenem treatment group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00051.6± 19.76(18 to 89) BG00152.3± 18.83(18 to 86) BG00252.0± 19.29(18 to 89)

Age, Customized

Number

Participants

Title

Denominators

Categories

18-45

Title	Measurements
	BG000192 BG001172 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000349 BG001357 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

American Indian Or Alaska Native

Title	Measurements
	BG0001 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Units	Counts
Participants	OG000393 OG001417

Title

Denominators

Categories

Symptomatic resolution

Title	Measurements
	OG000276 OG001276

Symptom persistence

Title	Measurements
	OG000

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
OG000 OG001	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	-12.5%

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

Units	Counts
Participants

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at TOC (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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at TOC (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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

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

Units	Counts
Participants	OG000

Secondary

Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000

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

Units	Counts
Participants	OG000480

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

Units	Counts
Participants	OG000483

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

Units	Counts
Participants	OG000481

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

Units	Counts
Participants	OG000489

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

Units	Counts
Participants	OG000490

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

Units	Counts
Participants	OG000488

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected509 at risk
Angina unstable	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected509 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Coronary artery aneurysm	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Abdominal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Chronic hepatitis C	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Diverticulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Orchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Tension headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected511 at risk EG0010 events0 affected509 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Renal impairment	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected509 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected509 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00011 events11 affected511 at risk EG0018 events7 affected509 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00014 events13 affected511 at risk EG0016 events6 affected509 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00016 events15 affected511 at risk EG00110 events10 affected509 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00041 events38 affected511 at risk EG00141 events40 affected509 at risk

Ancestor Terms

ID	Term
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D013424	Sulfanilamides
D000814	Aniline Compounds
D000588	Amines
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Term
C000595613	avibactam, ceftazidime drug combination
D000077726	Doripenem
D002939	Ciprofloxacin
D013420	Sulfamethoxazole
D014295	Trimethoprim

ID	Title	Description
BG000	CAZ-AVI	Ceftazidime-avibactam treatment group
BG001	Doripenem	Doripenem treatment group
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CAZ-AVI	Ceftazidime-avibactam treatment group			21	511	67	511
EG001	Doripenem	Doripenem treatment group			12	509	57	509