Trial Outcomes & Findings for Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis (NCT NCT00858637)
NCT ID: NCT00858637
Last Updated: 2014-12-30
Results Overview
Percent Change from Week 16 to Week 20 (LOCF)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
week20 minus week16
Results posted on
2014-12-30
Participant Flow
Participant milestones
| Measure |
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
* There was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
* There was a gap of 2 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject did not take any study medication and excluded from "Baseline Participants".
* In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
|---|---|---|---|---|---|---|
|
Active Comparison Phase
STARTED
|
127
|
0
|
0
|
133
|
0
|
0
|
|
Active Comparison Phase
COMPLETED
|
103
|
0
|
0
|
115
|
0
|
0
|
|
Active Comparison Phase
NOT COMPLETED
|
24
|
0
|
0
|
18
|
0
|
0
|
|
Placebo-controlled Withdrawal Phase
STARTED
|
0
|
49
|
54
|
0
|
56
|
59
|
|
Placebo-controlled Withdrawal Phase
COMPLETED
|
0
|
49
|
53
|
0
|
55
|
58
|
|
Placebo-controlled Withdrawal Phase
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
* There was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
* There was a gap of 2 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject did not take any study medication and excluded from "Baseline Participants".
* In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
|---|---|---|---|---|---|---|
|
Active Comparison Phase
Adverse Event
|
14
|
0
|
0
|
9
|
0
|
0
|
|
Active Comparison Phase
Death
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Active Comparison Phase
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Active Comparison Phase
Withdrawal by Subject
|
7
|
0
|
0
|
6
|
0
|
0
|
|
Active Comparison Phase
Other Reasons
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Placebo-controlled Withdrawal Phase
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Placebo-controlled Withdrawal Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Baseline characteristics by cohort
| Measure |
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
n=128 Participants
Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
* There was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
n=131 Participants
Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
* There was a gap of 2 subject between "STARTED" and "Overall Number of Baseline Participants".
* One subject did not take any study medication and excluded from "Baseline Participants".
* In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as "STARTED" of Simvastatin (Active) group but counted as "Baseline Participants" of MCI-196 (active) group.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week20 minus week16Population: ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.
Percent Change from Week 16 to Week 20 (LOCF)
Outcome measures
| Measure |
MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase
n=49 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase
n=53 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase
n=55 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase
n=58 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
|---|---|---|---|---|
|
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
|
4.03 Percent Change of LDL-cholesterol
Standard Deviation 19.92
|
42.55 Percent Change of LDL-cholesterol
Standard Deviation 30.96
|
2.76 Percent Change of LDL-cholesterol
Standard Deviation 18.43
|
49.84 Percent Change of LDL-cholesterol
Standard Deviation 41.89
|
SECONDARY outcome
Timeframe: week16 minus week0Population: ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.
Percent Change from Baseline to Week 16 (LOCF)
Outcome measures
| Measure |
MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase
n=125 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase
n=127 Participants
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase
Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
|
|---|---|---|---|---|
|
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
|
-25.67 Percent Change of LDL-cholesterol
Standard Deviation 19.45
|
-26.38 Percent Change of LDL-cholesterol
Standard Deviation 22.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeks and 20 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: throughout studyOutcome measures
Outcome data not reported
Adverse Events
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
Serious events: 16 serious events
Other events: 89 other events
Deaths: 0 deaths
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
Serious events: 12 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
n=128 participants at risk
Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
|
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
n=131 participants at risk
Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Angina unstable
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Peritonitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
2.3%
3/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Pyrexia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Gangrene
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Pneumonia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Postoperative wound infection
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Salmonella sepsis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Syncope
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
Other adverse events
| Measure |
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
n=128 participants at risk
Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
|
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
n=131 participants at risk
Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
11/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
9.2%
12/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Angina pectoris
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Angina unstable
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Aortic valve calcification
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Coronary artery stenosis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Palpitations
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Cardiac disorders
Sinus tachycardia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Ear and labyrinth disorders
Vertigo
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.9%
5/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.8%
5/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
3/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
2.3%
3/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.8%
5/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Constipation
|
4.7%
6/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
6.1%
8/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
4/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.8%
5/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Dry mouth
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
10/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
5.3%
7/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
3/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Gastric disorder
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Nausea
|
6.2%
8/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
9.2%
12/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Peritonitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Stomatitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.1%
4/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Asthenia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
2.3%
3/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Chest pain
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Hyperthermia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Oedema peripheral
|
3.1%
4/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
General disorders
Pyrexia
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
2.3%
3/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Hepatobiliary disorders
Hepatic pain
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Bronchitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Diabetic foot infection
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Endocarditis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Influenza
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Lymph node tuberculosis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Respiratory tract infection viral
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Rhinitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Tonsillitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.1%
4/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
5.3%
7/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
3.9%
5/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.8%
5/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
3.9%
5/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
6.1%
8/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Blood alkaline phosphatase increased
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Blood creatinine increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Blood parathyroid hormone increased
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Blood phosphorus increased
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Blood urea increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Body temperature increased
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Eosinophil count increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Lipids increased
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Investigations
Weight decreased
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
3/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.1%
4/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
3/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.1%
4/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
3.8%
5/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Dizziness
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
1.5%
2/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Headache
|
9.4%
12/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
4.6%
6/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Paraesthesia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Restless legs syndrome
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Syncope
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Nervous system disorders
Tonic convulsion
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Psychiatric disorders
Insomnia
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Psychiatric disorders
Stress
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Renal and urinary disorders
Renal failure
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Surgical and medical procedures
Hospitalisation
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Vascular disorders
Hypertension
|
4.7%
6/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
6.1%
8/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Vascular disorders
Hypertensive crisis
|
1.6%
2/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Vascular disorders
Hypotension
|
7.8%
10/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
6.9%
9/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Vascular disorders
Phlebitis
|
0.78%
1/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.00%
0/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/128 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
0.76%
1/131 • 16 weeks (Baseline - 16 weeks)
Baseline Characteristics are reported based on the safety population, which is the actual number of participants that received each intervention. Details are described in \[Arm/Group Description\] of \[Baseline Characteristics\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER