Trial Outcomes & Findings for A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE) (NCT NCT05781750)

Last Updated: 2025-12-05

Results Overview

Proportion of patients achieving complete renal response (CRR), defined as: * A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points) * An eGFR ≥60 mL/min/1.73 m\^2 or no confirmed decrease of \>20% from Baseline eGFR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Week 37

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Zetomipzomib 30 mg + Standard-of-care Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 60 mg + Standard-of-care Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Overall Study STARTED	27	29	28
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	27	29	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zetomipzomib 30 mg + Standard-of-care n=27 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 60 mg + Standard-of-care n=29 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=28 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.	Total n=84 Participants Total of all reporting groups
Age, Continuous	31.0 years STANDARD_DEVIATION 10.54 • n=37 Participants	32.5 years STANDARD_DEVIATION 9.44 • n=37 Participants	32.8 years STANDARD_DEVIATION 9.10 • n=74 Participants	32.1 years STANDARD_DEVIATION 9.61 • n=267 Participants
Sex: Female, Male Female	25 Participants n=37 Participants	28 Participants n=37 Participants	25 Participants n=74 Participants	78 Participants n=267 Participants
Sex: Female, Male Male	2 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants	6 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=37 Participants	10 Participants n=37 Participants	13 Participants n=74 Participants	28 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=37 Participants	19 Participants n=37 Participants	15 Participants n=74 Participants	56 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants	5 Participants n=37 Participants	2 Participants n=74 Participants	8 Participants n=267 Participants
Race (NIH/OMB) Asian	19 Participants n=37 Participants	15 Participants n=37 Participants	13 Participants n=74 Participants	47 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants	5 Participants n=267 Participants
Race (NIH/OMB) White	6 Participants n=37 Participants	7 Participants n=37 Participants	9 Participants n=74 Participants	22 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants	2 Participants n=267 Participants
Average 24-hour UPCR at Screening ≤3.0 mg/mg	13 Participants n=37 Participants	15 Participants n=37 Participants	13 Participants n=74 Participants	41 Participants n=267 Participants
Average 24-hour UPCR at Screening >3.0 mg/mg	14 Participants n=37 Participants	14 Participants n=37 Participants	15 Participants n=74 Participants	43 Participants n=267 Participants
Average 24-hour UPCR at Baseline	3.7 mg/mg STANDARD_DEVIATION 2.0 • n=37 Participants	3.6 mg/mg STANDARD_DEVIATION 2.1 • n=37 Participants	3.1 mg/mg STANDARD_DEVIATION 1.6 • n=74 Participants	3.5 mg/mg STANDARD_DEVIATION 1.9 • n=267 Participants
SLEDAI-2K	11.8 score on a scale STANDARD_DEVIATION 5.28 • n=37 Participants	11.7 score on a scale STANDARD_DEVIATION 5.48 • n=37 Participants	10.5 score on a scale STANDARD_DEVIATION 5.02 • n=74 Participants	11.3 score on a scale STANDARD_DEVIATION 5.23 • n=267 Participants
Time from SLE diagnosis to Screening	4.7 years STANDARD_DEVIATION 5.0 • n=37 Participants	8.1 years STANDARD_DEVIATION 6.2 • n=37 Participants	6.7 years STANDARD_DEVIATION 5.8 • n=74 Participants	6.5 years STANDARD_DEVIATION 5.8 • n=267 Participants
Time from LN diagnosis to Screening	1.8 years STANDARD_DEVIATION 2.3 • n=37 Participants	5.0 years STANDARD_DEVIATION 5.4 • n=37 Participants	4.3 years STANDARD_DEVIATION 4.5 • n=74 Participants	3.7 years STANDARD_DEVIATION 4.5 • n=267 Participants
LN Class Class III/IV ± V	23 participants n=37 Participants	26 participants n=37 Participants	24 participants n=74 Participants	73 participants n=267 Participants
LN Class Pure Class V	4 participants n=37 Participants	3 participants n=37 Participants	4 participants n=74 Participants	11 participants n=267 Participants

PRIMARY outcome

Timeframe: Week 37

Population: Participants in the intent to treat analysis set who reached Week 37 of treatment. Intent-to-treat set was defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the 37 week timepoint for efficacy analysis.

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=6 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=4 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=6 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Proportion of Patients Achieving Complete Renal Response	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 25 and Week 37

Population: Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.

Proportion of patients achieving PRR, defined as a: ≥50% reduction of UPCR from Baseline, and to \<1.0 if the Baseline UPCR was \<3.0 or to \<3.0 if the Baseline value was ≥3.0.

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=15 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=16 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=15 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Proportion of Patients Achieving Partial Renal Response (PRR) Week 25	8 Participants	5 Participants	6 Participants
Proportion of Patients Achieving Partial Renal Response (PRR) Week 37	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 25

Proportion of patients achieving complete renal response (CRR)

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=15 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=16 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=15 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Proportion of Patients Achieving Complete Renal Response	4 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 13, Week 25, and Week 37

Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=24 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Change in UPCR Week 13	-46.33 percent change in 24-hr UPCR value Standard Deviation 55.16	-33.08 percent change in 24-hr UPCR value Standard Deviation 34.37	-32.27 percent change in 24-hr UPCR value Standard Deviation 35.24
Change in UPCR Week 25	-61.56 percent change in 24-hr UPCR value Standard Deviation 50.85	-37.27 percent change in 24-hr UPCR value Standard Deviation 45.00	-40.33 percent change in 24-hr UPCR value Standard Deviation 42.47
Change in UPCR Week 37	-72.59 percent change in 24-hr UPCR value Standard Deviation 29.91	-68.39 percent change in 24-hr UPCR value Standard Deviation NA Only one participant receiving 30 mg zetomipzomib was analyzed.	-23.08 percent change in 24-hr UPCR value Standard Deviation 17.43

SECONDARY outcome

Timeframe: Baseline through Week 37

The comparison of the time to Complete Renal Response and Partial Renal Response for the zetomipzomib treatment groups (zetomipzomib 30mg and zetomipzomib 60mg) versus placebo. Hazard ratio (HR) and associated two-sided CIs are estimated using the Cox proportional hazards model. The model includes terms for treatment, the randomization stratification factors, and baseline UPCR (continuous).

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=24 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Time to Complete Renal Response and Partial Renal Response Complete Renal Response	26.9 weeks Interval 24.1 to NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.	NA weeks NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.	NA weeks NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.
Time to Complete Renal Response and Partial Renal Response Partial Renal Response	12.6 weeks Interval 12.1 to 24.0	24.3 weeks Interval 12.6 to NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.	25.1 weeks Interval 12.4 to NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.

SECONDARY outcome

Timeframe: Week 13, Week 25, and Week 37

Proportion of patients with UPCR ≤0.5

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=24 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Proportion of Patients With UPCR ≤0.5 Week 13	5 Participants	2 Participants	2 Participants
Proportion of Patients With UPCR ≤0.5 Week 25	5 Participants	1 Participants	3 Participants
Proportion of Patients With UPCR ≤0.5 Week 37	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 13, Week 25, and Week 37

Percent change from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=24 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) Week 25	-59.2 percent change of SLEDAI-2K score Standard Deviation 33.6	-18.6 percent change of SLEDAI-2K score Standard Deviation 45.9	-27.2 percent change of SLEDAI-2K score Standard Deviation 32.6
Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) Week 37	-36.4 percent change of SLEDAI-2K score Standard Deviation 51.4	-28.6 percent change of SLEDAI-2K score Standard Deviation NA Only one participant reached this timepoint.	-5.0 percent change of SLEDAI-2K score Standard Deviation 32.8
Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) Week 13	-56.4 percent change of SLEDAI-2K score Standard Deviation 24.1	-14.0 percent change of SLEDAI-2K score Standard Deviation 45.4	-19.5 percent change of SLEDAI-2K score Standard Deviation 33.7

POST_HOC outcome

Timeframe: Week 13, Week 25, and Week 37

Population: Participants in the intent to treat set defined as the participants with Class III/IV ± Class V lupus nephritis including the participant who was actually diagnosed as Class IV and was mistakenly stratified to Pure Class V. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.

Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=25 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Change in UPCR Week 13	-46.33 percent change in 24-hr UPCR value Standard Deviation 55.16	-33.08 percent change in 24-hr UPCR value Standard Deviation 34.37	-34.63 percent change in 24-hr UPCR value Standard Deviation 36.01
Change in UPCR Week 25	-61.56 percent change in 24-hr UPCR value Standard Deviation 50.85	-37.27 percent change in 24-hr UPCR value Standard Deviation 45.00	-40.33 percent change in 24-hr UPCR value Standard Deviation 42.47
Change in UPCR Week 37	-72.59 percent change in 24-hr UPCR value Standard Deviation 29.91	-68.39 percent change in 24-hr UPCR value Standard Deviation NA Only one participant receiving 30 mg zetomipzomib was analyzed.	-23.08 percent change in 24-hr UPCR value Standard Deviation 17.43

POST_HOC outcome

Timeframe: Week 13, Week 25, and Week 37

Proportion of Participants With UPCR ≤0.5

Outcome measures

Outcome measures
Measure	Zetomipzomib 60 mg + Standard-of-care n=26 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 30 mg + Standard-of-care n=23 Participants Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=25 Participants Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Proportion of Participants With UPCR ≤0.5 Week 13	5 Participants	2 Participants	2 Participants
Proportion of Participants With UPCR ≤0.5 Week 25	5 Participants	1 Participants	3 Participants
Proportion of Participants With UPCR ≤0.5 Week 37	1 Participants	0 Participants	0 Participants

Adverse Events

Zetomipzomib 30 mg + Standard-of-care

Serious events: 5 serious events

Other events: 23 other events

Deaths: 2 deaths

Zetomipzomib 60 mg + Standard-of-care

Serious events: 8 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo + Standard-of-care

Serious events: 3 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Regulatory Affairs

Kezar Life Sciences, Inc.

Phone: 650-822-5600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Zetomipzomib 30 mg + Standard-of-care n=27 participants at risk Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Zetomipzomib 60 mg + Standard-of-care n=29 participants at risk Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Placebo + Standard-of-care n=28 participants at risk Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
Cardiac disorders Cardiac failure	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Gastrointestinal disorders Gastritis	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Gastrointestinal disorders Nausea	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
General disorders Chills	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
General disorders Generalised oedema	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
General disorders Pyrexia	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Dengue fever	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Gastroenteritis salmonella	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Infections and infestations Gastroenteritis viral	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Herpes zoster	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Pneumonia	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Pneumonia bacterial	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Pseudomonas infection	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Infections and infestations Urinary tract infection	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Injury, poisoning and procedural complications Injection related reaction	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Investigations Blood pressure increased	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Metabolism and nutrition disorders Dehydration	0.00% 0/27 • Through end of study visit, up to 52 weeks	6.9% 2/29 • Number of events 2 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Nervous system disorders Cerebral ischaemia	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Psychiatric disorders Bipolar disorder	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Renal and urinary disorders Acute kidney injury	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	3.7% 1/27 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/27 • Through end of study visit, up to 52 weeks	0.00% 0/29 • Through end of study visit, up to 52 weeks	3.6% 1/28 • Number of events 1 • Through end of study visit, up to 52 weeks
Vascular disorders Hypovolaemic shock	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks
Vascular disorders Lupus vasculitis	0.00% 0/27 • Through end of study visit, up to 52 weeks	3.4% 1/29 • Number of events 1 • Through end of study visit, up to 52 weeks	0.00% 0/28 • Through end of study visit, up to 52 weeks