Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia
Conditions
Brief summary
This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) \[IMI/REL, MK-7655A\] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.
Interventions
DRUGIMI/REL FDC
500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial
DRUGPIP/TAZ FDC
4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial
DRUGLinezolid
Open-label 600 mg Linezolid
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Requires treatment with IV antibiotic therapy for HABP or VABP * Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP) * Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture * Has an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy * Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage * Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period * Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study * If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin
Exclusion criteria
* Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only * Has confirmed or suspected community-acquired bacterial pneumonia (CABP) * Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology * Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction * Has a carcinoid tumor or carcinoid syndrome * Has active immunosuppression * Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy * Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response * Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors * Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years * Is currently undergoing hemodialysis or peritoneal dialysis * A WOCBP who has a positive urine pregnancy test at screening * Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours * Is anticipated to be treated with any of the prohibited medications during the course of study therapy * Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial * Has previously participated in this study at any time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | Up to approximately 28 days | For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | Up to approximately 27 days | Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented. |
| Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | Up to approximately 14 days | Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy was required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented. |
| Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | Up to approximately 14 days | Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy is required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented. |
| Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population | Up to approximately 14 days | Favorable overall microbiological response rates were defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented. |
| Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | Up to approximately 27 days | Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented. |
| Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population | Up to approximately 14 days | Favorable overall microbiological response rates was defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented. |
| Percentage of Participants Experiencing Adverse Events (AEs) | Up to approximately 98 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm. |
| Percentage of Participants Discontinuing Study Drug Due to AEs | Up to approximately 14 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm. |
| Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population. | Up to approximately 27 days | A favorable by-pathogen microbiological response at EFU visit required eradication (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented. |
Countries
Brazil, China, France, Mexico, Philippines, Romania, Russia, Ukraine
Participant flow
Recruitment details
This study was conducted at 54 centers in 8 countries.
Pre-assignment details
Participants were randomized 1:1 to receive either FDC of imipenem/cilastatin (IMI) and relebactam (REL) \[IMI/REL, MK-7655A\], or piperacillin/tazobactam (PIP/TAZ).
Participants by arm
| Arm | Count |
|---|---|
| IMI/REL FDC Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total. | 138 |
| PIP/TAZ FDC Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total. | 136 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 7 |
| Overall Study | Participant Conducted Day 28 Visit Prior to the Required Time Window | 8 | 6 |
| Overall Study | Physician Decision | 3 | 2 |
| Overall Study | Withdrawal by Parent/Guardian | 16 | 10 |
| Overall Study | Withdrawal by Subject | 9 | 5 |
Baseline characteristics
| Characteristic | IMI/REL FDC | Total | PIP/TAZ FDC |
|---|---|---|---|
| Age, Continuous | 55.9 Years STANDARD_DEVIATION 15.1 | 57.5 Years STANDARD_DEVIATION 14.9 | 59.2 Years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 262 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 110 Participants | 212 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 60 Participants | 33 Participants |
| Randomization strata: Acute Physiology and Chronic Health Evaluation (APACHE) II score at baseline APACHE II Score <15 | 65 Participants | 126 Participants | 61 Participants |
| Randomization strata: Acute Physiology and Chronic Health Evaluation (APACHE) II score at baseline APACHE II Score ≥15 | 73 Participants | 148 Participants | 75 Participants |
| Randomization strata: Pneumonia type at baseline Non-ventilated HABP | 74 Participants | 154 Participants | 80 Participants |
| Randomization strata: Pneumonia type at baseline Ventilated HABP/VABP | 64 Participants | 120 Participants | 56 Participants |
| Sex: Female, Male Female | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Male | 101 Participants | 201 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 18 / 138 | 11 / 136 |
| other Total, other adverse events | 81 / 134 | 66 / 136 |
| serious Total, serious adverse events | 29 / 134 | 21 / 136 |
Outcome results
Primary
Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population
For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.
Time frame: Up to approximately 28 days
Population: The MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | 11.2 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population | 5.9 Percentage of Participants |
p-value: 0.02495% CI: [-1.5, 12.4]Miettinen & Nurminen method
p-value: 0.93895% CI: [-1.5, 12.4]Miettinen & Nurminen
Secondary
Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population
Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.
Time frame: Up to approximately 27 days
Population: MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | 50.7 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population | 47.8 Percentage of Participants |
95% CI: [-8.7, 14.9]
Secondary
Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population
Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.
Time frame: Up to approximately 27 days
Population: MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EFU visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | 64.6 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population | 62.2 Percentage of Participants |
95% CI: [-12.4, 16.8]
Secondary
Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population
Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy was required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.
Time frame: Up to approximately 14 days
Population: MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | 71.6 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population | 68.4 Percentage of Participants |
95% CI: [-7.6, 14.3]
Secondary
Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population
Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy is required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.
Time frame: Up to approximately 14 days
Population: MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EOT visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | 77.4 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population | 82.3 Percentage of Participants |
95% CI: [-15.8, 6.6]
Secondary
Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.
A favorable by-pathogen microbiological response at EFU visit required eradication (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.
Time frame: Up to approximately 27 days
Population: All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EFU.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population. | 80.0 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population. | 78.4 Percentage of Participants |
95% CI: [-16.5, 19.8]
Secondary
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population
Favorable overall microbiological response rates were defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.
Time frame: Up to approximately 14 days
Population: The MITT population consisted of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci. The microbiological modified intention-to-treat (mMITT) population was a subset of the MITT population that possessed a baseline bacterial pathogen isolated from a lower respiratory tract (LRT) specimen that was identified as the cause of HABP/VABP and against which IMI/REL has been shown to have antibacterial activity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population | 57.5 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population | 60.3 Percentage of Participants |
95% CI: [-17.8, 13.1]
Secondary
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population
Favorable overall microbiological response rates was defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.
Time frame: Up to approximately 14 days
Population: All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EOT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population | 71.9 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population | 74.5 Percentage of Participants |
95% CI: [-19.8, 14.4]
Secondary
Percentage of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.
Time frame: Up to approximately 14 days
Population: All randomized participants who received at least 1 dose of IV study therapy were assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Discontinuing Study Drug Due to AEs | 3.7 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Discontinuing Study Drug Due to AEs | 8.1 Percentage of Participants |
95% CI: [-10.7, 1.4]
Secondary
Percentage of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.
Time frame: Up to approximately 98 days
Population: All randomized participants who received at least 1 dose of IV study therapy were assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMI/REL FDC | Percentage of Participants Experiencing Adverse Events (AEs) | 86.6 Percentage of Participants |
| PIP/TAZ FDC | Percentage of Participants Experiencing Adverse Events (AEs) | 84.6 Percentage of Participants |
95% CI: [-6.5, 10.6]