Trial Outcomes & Findings for A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease (NCT NCT05432167)
NCT ID: NCT05432167
Last Updated: 2025-05-20
Results Overview
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
At Week 26
Results posted on
2025-05-20
Participant Flow
This study was conducted from 29 April 2022 to 02 May 2024 at 78 sites in the United States.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
CIN-107 Low Dosing Strategy Group
Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
|
CIN-107 High Dosing Strategy Group
Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
|
Placebo
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
66
|
|
Overall Study
COMPLETED
|
53
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
15
|
Reasons for withdrawal
| Measure |
CIN-107 Low Dosing Strategy Group
Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
|
CIN-107 High Dosing Strategy Group
Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
|
Placebo
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
|
Overall Study
Inclusion/exclusion criteria not met
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
11
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
CIN-107 Low Dosing Strategy Group
n=65 Participants
Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
|
CIN-107 High Dosing Strategy Group
n=64 Participants
Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
|
Placebo
n=66 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
67.2 Years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
66.5 Years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
65.6 Years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
66.4 Years
STANDARD_DEVIATION 11.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 26Population: Modified Intent-to-treat (mITT) population included all participants in the ITT population who received at least 1 dose of any study drug. Here, 'overall number of participants analyzed' means the number of participants with non-missing data.
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
Outcome measures
| Measure |
CIN-107 Treatment Groups Pooled
n=105 Participants
Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.
|
Placebo
n=48 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
Placebo
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
|
-15.22 Millimeters of mercury (mmHg)
Standard Error 1.532
|
-7.15 Millimeters of mercury (mmHg)
Standard Error 2.231
|
—
|
SECONDARY outcome
Timeframe: At Week 26Population: mITT population included all participants in the ITT population who received at least 1 dose of any study drug.
Mean change in seated SBP from baseline to Week 26 of high-dose CIN-107 dosing group and placebo was assessed.
Outcome measures
| Measure |
CIN-107 Treatment Groups Pooled
n=63 Participants
Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.
|
Placebo
n=64 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
Placebo
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
|
-14.37 mmHg
Standard Error 2.117
|
-7.16 mmHg
Standard Error 2.233
|
—
|
SECONDARY outcome
Timeframe: At Week 26Population: mITT population included all participants in the ITT population who received at least 1 dose of any study drug.
The mean change in seated SBP from baseline to Week 26 of low-dose CIN-107 dosing group and placebo was assessed.
Outcome measures
| Measure |
CIN-107 Treatment Groups Pooled
n=65 Participants
Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.
|
Placebo
n=64 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
Placebo
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
|
-16.14 mmHg
Standard Error 2.186
|
-7.16 mmHg
Standard Error 2.233
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization (Day 1) until the end of Follow up period (approximately 8 months)Population: Safety population included all participants who received at least one dose of any study drug.
The safety and tolerability of CIN-107 in participants with uncontrolled hypertension (uHTN) and chronic kidney disease (CKD) was assessed. Adverse events of special interest (AESI) include any hypotension events, abnormal potassium or sodium laboratory values that require clinical intervention.
Outcome measures
| Measure |
CIN-107 Treatment Groups Pooled
n=65 Participants
Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.
|
Placebo
n=63 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
Placebo
n=64 Participants
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All TEAEs
|
48 Participants
|
52 Participants
|
35 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All TEAEs, related to treatment
|
23 Participants
|
31 Participants
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE with outcome = Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE with outcome = Death, related to treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to dose interruption
|
20 Participants
|
23 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to dose interruption, related to treatment
|
10 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation of treatment
|
10 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation of treatment, related to treatment
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation of study
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation of study, related to treatment
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All treatment emergent serious adverse events (TESAEs)
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All TESAEs, related to treatment
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE with outcome = Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE with outcome = Death, related to treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to dose interruption
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to dose interruption, related to treatment
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to discontinuation of treatment
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to discontinuation of treatment, related to treatment
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to discontinuation of study
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TESAE leading to discontinuation of study, related to treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment emergent AESIs
|
11 Participants
|
12 Participants
|
4 Participants
|
Adverse Events
CIN-107 Low Dosing Strategy Group
Serious events: 7 serious events
Other events: 47 other events
Deaths: 0 deaths
CIN-107 High Dosing Strategy Group
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CIN-107 Low Dosing Strategy Group
n=65 participants at risk
Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
|
CIN-107 High Dosing Strategy Group
n=63 participants at risk
Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
|
Placebo
n=64 participants at risk
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Eye infection
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Toxic encephalopathy
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.6%
3/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Chest pain
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Generalised oedema
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
Other adverse events
| Measure |
CIN-107 Low Dosing Strategy Group
n=65 participants at risk
Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
|
CIN-107 High Dosing Strategy Group
n=63 participants at risk
Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
|
Placebo
n=64 participants at risk
Participants received oral tablets of Placebo for 26 weeks.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
32.3%
21/65 • Number of events 30 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
50.8%
32/63 • Number of events 52 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.7%
3/64 • Number of events 4 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
4/65 • Number of events 5 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood creatinine increased
|
16.9%
11/65 • Number of events 14 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
23.8%
15/63 • Number of events 20 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
7.8%
5/64 • Number of events 7 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
6.3%
4/63 • Number of events 4 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
7.8%
5/64 • Number of events 6 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Lipase increased
|
3.1%
2/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.8%
3/63 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood potassium increased
|
6.2%
4/65 • Number of events 4 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood urea increased
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Amylase increased
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood bicarbonate decreased
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Cardiac murmur
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Electrocardiogram QRS complex shortened
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Electrocardiogram QT interval abnormal
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Liver function test abnormal
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
3/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 5 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.8%
3/63 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
COVID-19
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Cystitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Cellulitis
|
3.1%
2/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Folliculitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Tinea capitis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Trichomoniasis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Renal impairment
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
7.9%
5/63 • Number of events 5 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.7%
3/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.7%
3/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
6.2%
4/64 • Number of events 4 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Dysuria
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
7.9%
5/63 • Number of events 5 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
2/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
6.2%
4/64 • Number of events 4 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Hypotension
|
4.6%
3/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Hypertension
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
3/65 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.8%
3/63 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.7%
3/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Dental caries
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Oedema peripheral
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Fatigue
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Chest pain
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Malaise
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Mass
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
General disorders
Swelling
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Arrhythmia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
Palpitations
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.7%
3/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
4.8%
3/63 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.2%
2/63 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Syncope
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
3.1%
2/64 • Number of events 3 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
2/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Eye disorders
Diplopia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eye
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.5%
1/65 • Number of events 2 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/64 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Endocrine disorders
Hypoparathyroidism
|
1.5%
1/65 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/63 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/65 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
1.6%
1/63 • Number of events 1 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
0.00%
0/64 • From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Safety population included all participants who received at least one dose of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER