Trial Outcomes & Findings for Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021) (NCT NCT03969901)
NCT ID: NCT03969901
Last Updated: 2026-02-05
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs are presented.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
115 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2026-02-05
Participant Flow
Participant milestones
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younge Children (2 to <6 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5 Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
31
|
11
|
22
|
8
|
15
|
5
|
8
|
3
|
|
Overall Study
Treated
|
10
|
2
|
31
|
11
|
21
|
8
|
15
|
4
|
8
|
3
|
|
Overall Study
COMPLETED
|
10
|
2
|
31
|
11
|
21
|
8
|
15
|
4
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younge Children (2 to <6 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5 Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
Baseline characteristics by cohort
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=22 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=5 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
12 Participants
|
4 Participants
n=140 Participants
|
5 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
43 Participants
n=12 Participants
|
|
Age, Continuous
|
15.1 Years
STANDARD_DEVIATION 2.0 • n=41 Participants
|
16.5 Years
STANDARD_DEVIATION 0.7 • n=1581 Participants
|
8.4 Years
STANDARD_DEVIATION 1.7 • n=4626 Participants
|
8.0 Years
STANDARD_DEVIATION 1.7 • n=72 Participants
|
3.5 Years
STANDARD_DEVIATION 1.1
|
4.3 Years
STANDARD_DEVIATION 1.2 • n=140 Participants
|
0.9 Years
STANDARD_DEVIATION 0.5 • n=58 Participants
|
0.7 Years
STANDARD_DEVIATION 0.6 • n=12 Participants
|
0.1 Years
STANDARD_DEVIATION 0.1 • n=12 Participants
|
0.1 Years
STANDARD_DEVIATION 0.1 • n=12 Participants
|
5.8 Years
STANDARD_DEVIATION 4.7 • n=12 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
8 Participants
n=72 Participants
|
12 Participants
|
3 Participants
n=140 Participants
|
7 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
56 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
10 Participants
|
5 Participants
n=140 Participants
|
8 Participants
n=58 Participants
|
4 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
59 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
10 Participants
|
4 Participants
n=140 Participants
|
9 Participants
n=58 Participants
|
4 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
70 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
1 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
27 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
19 Participants
|
4 Participants
n=140 Participants
|
11 Participants
n=58 Participants
|
5 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
94 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
2 Participants
n=140 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Infection Type
cIAI
|
5 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
14 Participants
|
5 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
0.0 Participants
n=12 Participants
|
0.0 Participants
n=12 Participants
|
54 Participants
n=12 Participants
|
|
Infection Type
cUTI
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
6 Participants
|
2 Participants
n=140 Participants
|
14 Participants
n=58 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
55 Participants
n=12 Participants
|
|
Infection Type
HABP/VABP
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
1 Participants
n=140 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs are presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With One or More Adverse Event (AE)
|
60.0 Percentage of Participants
|
50.0 Percentage of Participants
|
64.5 Percentage of Participants
|
36.4 Percentage of Participants
|
71.4 Percentage of Participants
|
62.5 Percentage of Participants
|
93.3 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
66.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study medication due to an AE are presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
12.9 Percentage of Participants
|
9.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
6.7 Percentage of Participants
|
25.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
For each participant, survival status was assessed at Day 28 post-randomization. The percentage of participants with all-cause mortality through Day 28 is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With All-cause Mortality Through Day 28
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 5 up to Day 14Population: The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
A favorable clinical response at EOT requires an assessment of "cure" or "improved". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Improved is defined as the majority of preintervention signs and symptoms of the index infection have improved or resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required. The percentage of participants with a favorable clinical response at EOT is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)
|
90.0 Percentage of Participants
Interval 57.4 to 100.0
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
77.4 Percentage of Participants
Interval 59.9 to 88.9
|
81.8 Percentage of Participants
Interval 51.2 to 96.0
|
90.5 Percentage of Participants
Interval 69.9 to 98.6
|
87.5 Percentage of Participants
Interval 50.8 to 99.9
|
53.3 Percentage of Participants
Interval 30.1 to 75.2
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
87.5 Percentage of Participants
Interval 50.8 to 99.9
|
33.3 Percentage of Participants
Interval 5.6 to 79.8
|
SECONDARY outcome
Timeframe: Day 12 up to Day 28Population: The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
A favorable clinical response at EFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at EFU is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU)
|
90.0 Percentage of Participants
Interval 57.4 to 100.0
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
77.4 Percentage of Participants
Interval 59.9 to 88.9
|
81.8 Percentage of Participants
Interval 51.2 to 96.0
|
85.7 Percentage of Participants
Interval 64.5 to 95.9
|
87.5 Percentage of Participants
Interval 50.8 to 99.9
|
26.7 Percentage of Participants
Interval 10.5 to 52.4
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
62.5 Percentage of Participants
Interval 30.4 to 86.5
|
33.3 Percentage of Participants
Interval 5.6 to 79.8
|
SECONDARY outcome
Timeframe: Baseline and Day 19 up to Day 42Population: The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.
A favorable clinical response at LFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at LFU is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)
|
90.0 Percentage of Participants
Interval 57.4 to 100.0
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
74.2 Percentage of Participants
Interval 56.5 to 86.5
|
81.8 Percentage of Participants
Interval 51.2 to 96.0
|
81.0 Percentage of Participants
Interval 59.4 to 92.9
|
87.5 Percentage of Participants
Interval 50.8 to 99.9
|
33.3 Percentage of Participants
Interval 15.0 to 58.5
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
62.5 Percentage of Participants
Interval 30.4 to 86.5
|
33.3 Percentage of Participants
Interval 5.6 to 79.8
|
SECONDARY outcome
Timeframe: Day 5 up to Day 14Population: For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
A favorable microbial response is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EOT visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EOT visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EOT visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EOT is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=7 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=1 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=27 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=10 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=16 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=5 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=11 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=7 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)
|
100.0 Percentage of Participants
Interval 59.6 to 100.0
|
100.0 Percentage of Participants
Interval 16.7 to 100.0
|
100.0 Percentage of Participants
Interval 85.2 to 100.0
|
100.0 Percentage of Participants
Interval 67.9 to 100.0
|
100.0 Percentage of Participants
Interval 77.3 to 100.0
|
100.0 Percentage of Participants
Interval 51.1 to 100.0
|
72.7 Percentage of Participants
Interval 42.9 to 90.8
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
100.0 Percentage of Participants
Interval 59.6 to 100.0
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
SECONDARY outcome
Timeframe: Day 12 up to Day 28Population: For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
A favorable microbiological response at EFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EFU visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EFU is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=7 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=1 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=27 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=10 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=16 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=5 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=11 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=7 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)
|
71.4 Percentage of Participants
Interval 35.2 to 92.4
|
100.0 Percentage of Participants
Interval 16.7 to 100.0
|
96.3 Percentage of Participants
Interval 80.2 to 100.0
|
100.0 Percentage of Participants
Interval 67.9 to 100.0
|
93.8 Percentage of Participants
Interval 69.7 to 100.0
|
100.0 Percentage of Participants
Interval 51.1 to 100.0
|
63.6 Percentage of Participants
Interval 35.2 to 85.0
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
71.4 Percentage of Participants
Interval 35.2 to 92.4
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
SECONDARY outcome
Timeframe: Day 19 up to Day 42Population: For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
A favorable microbiological response at LFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the LFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the LFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the LFU visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at LFU is presented.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=7 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=1 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=27 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=10 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=16 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=5 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=11 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=7 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=2 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)
|
85.7 Percentage of Participants
Interval 46.7 to 99.5
|
0.0 Percentage of Participants
Interval 0.0 to 83.3
|
96.3 Percentage of Participants
Interval 80.2 to 100.0
|
100.0 Percentage of Participants
Interval 67.9 to 100.0
|
87.5 Percentage of Participants
Interval 62.7 to 97.8
|
100.0 Percentage of Participants
Interval 51.1 to 100.0
|
72.7 Percentage of Participants
Interval 42.9 to 90.8
|
75.0 Percentage of Participants
Interval 28.9 to 96.6
|
71.4 Percentage of Participants
Interval 35.2 to 92.4
|
50.0 Percentage of Participants
Interval 9.5 to 90.5
|
SECONDARY outcome
Timeframe: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.Population: The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Blood samples were collected to determine the AUC0-24 of imipenem.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=31 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=15 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL
|
610 µM*hr
Geometric Coefficient of Variation 55.5
|
720 µM*hr
Geometric Coefficient of Variation 25.8
|
692 µM*hr
Geometric Coefficient of Variation 23.5
|
788 µM*hr
Geometric Coefficient of Variation 28.4
|
795 µM*hr
Geometric Coefficient of Variation 19.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.Population: The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Blood samples were collected to determine the AUC0-24 of relebactam.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=31 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=15 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Relebactam Following Administration of IMI/REL
|
399 µM*hr
Geometric Coefficient of Variation 64
|
469 µM*hr
Geometric Coefficient of Variation 30.9
|
459 µM*hr
Geometric Coefficient of Variation 30.4
|
634 µM*hr
Geometric Coefficient of Variation 56.8
|
605 µM*hr
Geometric Coefficient of Variation 50.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the end of the first infusion on Day 1.Population: The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
Ceoi is the concentration of the drug at the end of infusion. Blood samples for analysis were collected within 10 minutes of the end of infusion to determine the Ceoi of imipenem.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=31 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=15 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL
|
79.2 µM
Geometric Coefficient of Variation 17.6
|
103 µM
Geometric Coefficient of Variation 15
|
101 µM
Geometric Coefficient of Variation 12.7
|
109 µM
Geometric Coefficient of Variation 14.1
|
117 µM
Geometric Coefficient of Variation 5.51
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the end of the first infusion on Day 1.Population: The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
Ceoi is the concentration of the drug at the end of infusion. Blood samples for analysis were collected within 10 minutes of the end of infusion to determine the Ceoi of relebactam.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=31 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=21 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=15 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=8 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration at End of Infusion (Ceoi) of Relebactam Following Administration of IMI/REL
|
43.4 µM
Geometric Coefficient of Variation 28.6
|
56.1 µM
Geometric Coefficient of Variation 18.6
|
56.1 µM
Geometric Coefficient of Variation 16.2
|
67.1 µM
Geometric Coefficient of Variation 27.4
|
67.9 µM
Geometric Coefficient of Variation 22.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.Population: The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample for %T\>MIC.
Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T\>MIC) is defined as the cumulative percentage the drug concentration exceeds the MIC at steady state pharmacokinetic conditions. Blood samples were collected to determine %T\>MIC of imipenem. %T\>MIC is calculated using baseline microbiological response values.
Outcome measures
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=6 Participants
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Cohort 1: Adolescents: (12 to <18 Years)
n=22 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=15 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=8 Participants
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=6 Participants
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T>MIC of Imipenem) Following Administration of IMI/REL
|
100.0 Percentage of time
Standard Deviation 0.0
|
93.4 Percentage of time
Standard Deviation 22.1
|
83.6 Percentage of time
Standard Deviation 23.1
|
79.6 Percentage of time
Standard Deviation 35.3
|
83.5 Percentage of time
Standard Deviation 25.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Active Control Age Cohort 2: Older Children (6 to <12 Years)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 participants at risk
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
n=2 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.5%
2/31 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Drug intolerance
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Neonatal infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)
n=10 participants at risk
Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 1: Adolescents (12 to <18 Years)
n=2 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 2: Older Children (6 to <12 Years)
n=31 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 2: Older Children (6 to <12 Years)
n=11 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)
n=21 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 3: Younger Children (2 to <6 Years)
n=8 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=15 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)
n=4 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=8 participants at risk
Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
|
Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)
n=3 participants at risk
Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
pH urine increased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.5%
2/31 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
25.0%
2/8 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.9%
4/31 • Number of events 4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.9%
4/31 • Number of events 4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
14.3%
3/21 • Number of events 3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
16.1%
5/31 • Number of events 15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
16.1%
5/31 • Number of events 5 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
19.0%
4/21 • Number of events 5 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
37.5%
3/8 • Number of events 5 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.5%
2/31 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Thirst
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.1%
1/11 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.7%
3/31 • Number of events 3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Creatinine urine decreased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Urine uric acid increased
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.5%
2/31 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urethral fistula
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/31 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
3.2%
1/31 • Number of events 1 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/11 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/15 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/8 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 42 days
All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER