Trial Outcomes & Findings for A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients. (NCT NCT03303521)

Last Updated: 2020-02-20

Results Overview

A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval and did not receive rescue therapy. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

196 participants

Primary outcome timeframe

Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.

Results posted on

2020-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Sodium Zirconium Cyclosilicate (SZC) Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Overall Study STARTED	97	99
Overall Study COMPLETED	92	96
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Zirconium Cyclosilicate (SZC) Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Overall Study Withdrawal by Subject	2	0
Overall Study Death	1	0
Overall Study Kidney transplantation	0	1
Overall Study Investigational product discontinuation	0	1
Overall Study Transferred to non-study dialysis center	1	0
Overall Study Non-comliance to study protocol	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Zirconium Cyclosilicate (SZC) n=97 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Total n=196 Participants Total of all reporting groups
Age, Continuous	55.7 Years STANDARD_DEVIATION 13.84 • n=5 Participants	60.4 Years STANDARD_DEVIATION 13.2 • n=7 Participants	58.1 Years STANDARD_DEVIATION 13.69 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized White	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alasa Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.

Population: Full Analysis Set (all randomized patients)

Outcome measures

Outcome measures
Measure	Sodium Zirconium Cyclosilicate (SZC) n=97 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Percentage of Responders	41.2 Percentage of participants	1.0 Percentage of participants

PRIMARY outcome

Population: Full Analysis Set (all randomized patients)

The sensitivity analysis assessed the impact of subjects classified as non-responders due to missing serum potassium (S-K) data. Missing central lab (c-lab) pre-dialysis values were imputed using corresponding pre-dialysis i-STAT (a portable blood analyser) measurements. In addition, a "last observation carried forward" (LOCF) approach was utilized to further impute missing values of pre-dialysis S-K during the evaluation period. This technique will replace missing c-lab S-K values with the last available non-missing pre-dialysis LIDI observation recorded for that patient (and this could be a c-lab value or an imputed c-lab value). The Primary endpoint analysis was repeated on the imputed data.

Outcome measures

Outcome measures
Measure	Sodium Zirconium Cyclosilicate (SZC) n=97 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data	42.3 Percentage of participants	2.0 Percentage of participants

SECONDARY outcome

Timeframe: An 8 week overall treatment period (a 4 week adjustment phase plus a 4 week evaluation phase) and a 2 week follow up period.

Population: Full Analysis Set (all randomized patients)

Patients requiring any urgent intervention consistent with local practice patterns to reduce serum potassium (S-K) including insulin/glucose, beta-adrenergic agonists, sodium bicarbonate, K binders or any form of renal replacement therapy.

Outcome measures

Outcome measures
Measure	Sodium Zirconium Cyclosilicate (SZC) n=97 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 Participants Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Percentage of Patients Needing Rescue Therapy	2.1 Percentage of participants	5.1 Percentage of participants

Adverse Events

Sodium Zirconium Cyclosilicate (SZC)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 1 deaths

Placebo

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sodium Zirconium Cyclosilicate (SZC) n=96 participants at risk Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 participants at risk Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Infections and infestations Bacteraemia	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Infections and infestations Gangrene	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Infections and infestations Gastroenteritis viral	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Infections and infestations Vascular device infection	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Metabolism and nutrition disorders Fluid overload	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	2.0% 2/99 • Number of events 2 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Metabolism and nutrition disorders Hyperkalaemia	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	3.0% 3/99 • Number of events 3 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Cardiac disorders Angina pectoris	2.1% 2/96 • Number of events 3 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Vascular disorders Peripheral arterial occlusive disease	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 2 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Gastrointestinal disorders Small intestinal obstruction	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	1.0% 1/96 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	0.00% 0/99 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/96 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	1.0% 1/99 • Number of events 1 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.

Other adverse events

Other adverse events
Measure	Sodium Zirconium Cyclosilicate (SZC) n=96 participants at risk Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.	Placebo n=99 participants at risk Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose). Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
Infections and infestations Nasopharyngitis	3.1% 3/96 • Number of events 4 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	5.1% 5/99 • Number of events 5 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
Gastrointestinal disorders Diarrhoea	4.2% 4/96 • Number of events 5 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.	6.1% 6/99 • Number of events 6 • Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent. Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=96 for SZC, N=99 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.

Additional Information

AstraZeneca Clinical

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place