Trial Outcomes & Findings for Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) (NCT NCT02092350)
NCT ID: NCT02092350
Last Updated: 2018-09-24
Results Overview
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
237 participants
Primary outcome timeframe
Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
Results posted on
2018-09-24
Participant Flow
This multi-site study enrolled adult, male and female participants with hepatitis C virus (HCV) genotype (GT) 1 with chronic kidney disease (CKD).
The screening period lasted for up to 60 days.
Participant milestones
| Measure |
Immediate Treatment + Intensive PK
Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
|
Deferred Treatment
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
114
|
|
Overall Study
COMPLETED
|
113
|
102
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Immediate Treatment + Intensive PK
Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
|
Deferred Treatment
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Screen Failure
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Baseline characteristics by cohort
| Measure |
Immediate Treatment + Intensive PK
n=123 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=114 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
55.2 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
55.9 Years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)Population: The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Immediate Treatment + Intensive PK
n=116 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=99 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
98.0 Percentage of participants
Interval 92.9 to 99.8
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Outcome measures
| Measure |
Immediate Treatment + Intensive PK
n=122 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=113 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods
|
93 Participants
|
96 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: The APaT population includes all enrolled participants who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Outcome measures
| Measure |
Immediate Treatment + Intensive PK
n=122 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=113 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)Population: The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
SVR24 was defined as HCV RNA \<LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Immediate Treatment + Intensive PK
n=114 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=99 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
|
97.4 Percentage of participants
Interval 92.5 to 99.5
|
98.0 Percentage of participants
Interval 92.9 to 99.8
|
SECONDARY outcome
Timeframe: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)Population: The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
SVR4 was defined as HCV RNA \<LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Immediate Treatment + Intensive PK
n=118 Participants
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment
n=101 Participants
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)
|
100.00 Percentage of participants
Interval 96.9 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
Adverse Events
Immediate Treatment + Intensive PK
Serious events: 30 serious events
Other events: 67 other events
Deaths: 0 deaths
Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks
Serious events: 22 serious events
Other events: 68 other events
Deaths: 0 deaths
Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
Serious events: 25 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Treatment + Intensive PK
n=122 participants at risk
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks
n=113 participants at risk
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
|
Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
n=102 participants at risk
Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.0%
2/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Cardiac arrest
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Myocardial infarction
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Constipation
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
1.8%
2/113 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Chest pain
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Death
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Non-cardiac chest pain
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Pyrexia
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Abscess limb
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Appendicitis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Citrobacter sepsis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Enterobacter sepsis
|
0.82%
1/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Infected fistula
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Osteomyelitis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Pneumonia
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Postoperative wound infection
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Sepsis
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Genital injury
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Investigations
Electrocardiogram abnormal
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Investigations
Lipase increased
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Headache
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Hemiparesis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Presyncope
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
1.8%
2/113 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Cryoglobulinaemia
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Extremity necrosis
|
0.82%
1/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Hypertension
|
1.6%
2/122 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Hypertensive crisis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Nocardiosis
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Pneumonia bacterial
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Septic shock
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Infections and infestations
Urinary tract infection
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.82%
1/122 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal effusion
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.88%
1/113 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/102 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Aortic stenosis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Seizure
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.00%
0/113 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
Other adverse events
| Measure |
Immediate Treatment + Intensive PK
n=122 participants at risk
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
|
Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks
n=113 participants at risk
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
|
Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
n=102 participants at risk
Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
2/122 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
10/122 • Number of events 13 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.7%
3/113 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Constipation
|
6.6%
8/122 • Number of events 8 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 7 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
6/122 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
13.3%
15/113 • Number of events 22 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
4.9%
5/102 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Nausea
|
14.8%
18/122 • Number of events 24 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
15.9%
18/113 • Number of events 21 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
10.8%
11/102 • Number of events 12 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
9/122 • Number of events 13 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
8.0%
9/113 • Number of events 11 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
6.9%
7/102 • Number of events 10 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Asthenia
|
5.7%
7/122 • Number of events 9 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
3.9%
4/102 • Number of events 4 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Fatigue
|
10.7%
13/122 • Number of events 15 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
15.0%
17/113 • Number of events 17 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
9.8%
10/102 • Number of events 10 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
General disorders
Pyrexia
|
4.9%
6/122 • Number of events 7 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.9%
3/102 • Number of events 4 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
7/122 • Number of events 8 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.7%
3/113 • Number of events 3 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
3.9%
4/102 • Number of events 4 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/122 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
7.1%
8/113 • Number of events 9 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.0%
2/102 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Dizziness
|
6.6%
8/122 • Number of events 9 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
15.9%
18/113 • Number of events 22 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
3.9%
4/102 • Number of events 4 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Nervous system disorders
Headache
|
18.9%
23/122 • Number of events 26 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
15.9%
18/113 • Number of events 23 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
6.9%
7/102 • Number of events 8 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Psychiatric disorders
Insomnia
|
8.2%
10/122 • Number of events 10 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
10.6%
12/113 • Number of events 12 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.0%
2/102 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
9/122 • Number of events 10 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
1.8%
2/113 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
4.9%
5/102 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
4/122 • Number of events 4 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
10.6%
12/113 • Number of events 12 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
0.98%
1/102 • Number of events 1 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
|
Vascular disorders
Hypertension
|
5.7%
7/122 • Number of events 7 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
5.3%
6/113 • Number of events 6 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
2.0%
2/102 • Number of events 2 • Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER