Trial Outcomes & Findings for Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD) (NCT NCT02966028)
NCT ID: NCT02966028
Last Updated: 2021-04-15
Results Overview
Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
274 participants
Primary outcome timeframe
Baseline (Week 1, Day 1) and Week 52
Results posted on
2021-04-15
Participant Flow
Participant milestones
| Measure |
SNF472 300 mg
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
SNF 472 600 mg
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
91
|
91
|
|
Overall Study
COMPLETED
|
68
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
24
|
34
|
31
|
Reasons for withdrawal
| Measure |
SNF472 300 mg
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
SNF 472 600 mg
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
13
|
10
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
5
|
|
Overall Study
Kidney transplant Changed dialysis units
|
9
|
16
|
14
|
Baseline Characteristics
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
Baseline characteristics by cohort
| Measure |
SNF472 300 mg
n=92 Participants
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
SNF 472 600 mg
n=91 Participants
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=90 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
64. years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
54 participants
n=5 Participants
|
165 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
28 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
CAC Agatston Score
|
917 units on a scale
STANDARD_DEVIATION 697 • n=5 Participants
|
963 units on a scale
STANDARD_DEVIATION 702 • n=7 Participants
|
965 units on a scale
STANDARD_DEVIATION 762 • n=5 Participants
|
948 units on a scale
STANDARD_DEVIATION 744 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=142 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=77 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo
|
1.11 ratio
Interval 1.067 to 1.153
|
1.20 ratio
Interval 1.138 to 1.262
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=77 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=65 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=77 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo
|
1.12 ratio
Interval 1.06 to 1.175
|
1.10 ratio
Interval 1.042 to 1.165
|
1.20 ratio
Interval 1.138 to 1.262
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=77 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=65 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=142 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=77 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log CAC Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and for the Combined Dose Groups vs the Placebo Group
|
1.10 ratio
Interval 1.027 to 1.17
|
1.13 ratio
Interval 1.055 to 1.215
|
1.11 ratio
Interval 1.06 to 1.17
|
1.20 ratio
Interval 1.122 to 1.278
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Agatston score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 were calculated as a percentage of change (progression or worsening of calcification). The number of subjects with \<15% progression were counted.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=77 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=65 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=142 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=77 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Number of Subjects With <15% Progression in CAC Agatston Score From Baseline to Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo
|
46 Participants
|
41 Participants
|
87 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Agatston score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 was calculated as a percentage of change (progression or worsening of calcification). The number of subjects with \>=15% progression were counted for each treatment group, the combined treatments groups and placebo.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=77 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=65 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=142 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=77 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo
|
31 Participants
|
24 Participants
|
55 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the thoracic aorta was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=74 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=60 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=134 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=75 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log Thoracic Aorta Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
|
1.25 ratio
Interval 1.156 to 1.346
|
1.21 ratio
Interval 1.113 to 1.318
|
1.23 ratio
Interval 1.161 to 1.302
|
1.28 ratio
Interval 1.187 to 1.381
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in CAC Agatston Score in the thoracic aorta from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=74 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=60 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=134 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=75 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
|
1.30 ratio
Interval 1.186 to 1.432
|
1.28 ratio
Interval 1.149 to 1.416
|
1.29 ratio
Interval 1.201 to 1.384
|
1.32 ratio
Interval 1.205 to 1.452
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the aortic valve was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=75 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=63 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=138 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=69 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log Aortic Valve Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
|
1.28 ratio
Interval 1.143 to 1.426
|
1.01 ratio
Interval 0.899 to 1.144
|
1.14 ratio
Interval 1.048 to 1.235
|
1.98 ratio
Interval 1.768 to 2.226
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score or the aortic valve from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=75 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=63 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=138 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=69 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
|
1.33 ratio
Interval 1.141 to 1.541
|
0.98 ratio
Interval 0.836 to 1.16
|
1.14 ratio
Interval 1.022 to 1.277
|
2.86 ratio
Interval 2.449 to 3.349
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Safety Population
The number of subjects meeting this composite safety endpoint were counted and expressed by the randomized arm as a % of patients for the safety population.terms resulting in death from cardiovascular causes, myocardial infarction, stroke, or heart failure for each dose group and placebo were summarized .
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=92 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=91 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=183 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=90 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.
|
7 Participants
|
6 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 1, Day 1) and Week 52Population: Safety Population
The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population.
Outcome measures
| Measure |
SNF472 300 mg & 600 mg Combined
n=92 Participants
Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=91 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=183 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=90 Participants
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|---|
|
Mortality Rate (All-cause) for Each Dose Group and Placebo
|
1 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
SNF472 300 mg
Serious events: 38 serious events
Other events: 62 other events
Deaths: 1 deaths
SNF 472 600 mg
Serious events: 55 serious events
Other events: 64 other events
Deaths: 6 deaths
Matching Placebo
Serious events: 49 serious events
Other events: 67 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
SNF472 300 mg
n=92 participants at risk
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
SNF 472 600 mg
n=91 participants at risk
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=90 participants at risk
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
General disorders
Chest pain
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
3.3%
3/90 • Number of events 3 • Collected over one year
|
|
General disorders
Pyrexia
|
0.00%
0/92 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
General disorders
Asthenia
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
General disorders
Systemic inflammatory response syndrome
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Investigations
International normalised ratio increased
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Investigations
Stress echocardiogram abnormal
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Investigations
Troponin increased
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Eye disorders
Retinal detachment
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Pneumonia
|
4.3%
4/92 • Number of events 4 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
7.8%
7/90 • Number of events 7 • Collected over one year
|
|
Infections and infestations
Sepsis
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Cellulitis
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Septic shock
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Arteriovenous graft site infection
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Device related infection
|
0.00%
0/92 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Endocarditis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Gangrene
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/92 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Arteriovenous graft site abscess
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Emphysematous cystitis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Enterocolitis viral
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Influenza
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Localised infection
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Osteomyelitis bacterial
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Vascular access site infection
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Infections and infestations
Wound infection
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Surgical and medical procedures
Renal Transplant
|
6.5%
6/92 • Number of events 6 • Collected over one year
|
15.4%
14/91 • Number of events 14 • Collected over one year
|
12.2%
11/90 • Number of events 11 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/92 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arterial injury
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
3/92 • Number of events 3 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
4.4%
4/90 • Number of events 4 • Collected over one year
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/92 • Collected over one year
|
3.3%
3/91 • Number of events 3 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Cardiac disorders
Cardiogenic shock
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Left ventricular failure
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/92 • Collected over one year
|
4.4%
4/91 • Number of events 4 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Abdominal mass
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Vascular disorders
Hypotension
|
3.3%
3/92 • Number of events 3 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Vascular disorders
Hypertension
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Vascular disorders
Haematoma
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/92 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Vascular disorders
Foreign body embolism
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
3.3%
3/90 • Number of events 3 • Collected over one year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Nervous system disorders
Cognitive disorder
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Nervous system disorders
Seizure
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Nervous system disorders
Syncope
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/92 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
1.1%
1/90 • Number of events 1 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
0.00%
0/91 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/92 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
0.00%
0/90 • Collected over one year
|
Other adverse events
| Measure |
SNF472 300 mg
n=92 participants at risk
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
SNF 472 600 mg
n=91 participants at risk
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
Matching Placebo
n=90 participants at risk
Placebo arm: 2 vials of physiological saline
Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
7/92 • Number of events 7 • Collected over one year
|
12.1%
11/91 • Number of events 11 • Collected over one year
|
11.1%
10/90 • Number of events 10 • Collected over one year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.0%
11/92 • Number of events 11 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
2.2%
2/90 • Number of events 2 • Collected over one year
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • Number of events 1 • Collected over one year
|
8.8%
8/91 • Number of events 8 • Collected over one year
|
4.4%
4/90 • Number of events 4 • Collected over one year
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
5.5%
5/91 • Number of events 5 • Collected over one year
|
4.4%
4/90 • Number of events 4 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.6%
7/92 • Number of events 7 • Collected over one year
|
7.7%
7/91 • Number of events 7 • Collected over one year
|
7.8%
7/90 • Number of events 7 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
3/92 • Number of events 3 • Collected over one year
|
6.6%
6/91 • Number of events 6 • Collected over one year
|
5.6%
5/90 • Number of events 5 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
6/92 • Number of events 6 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
4.4%
4/90 • Number of events 4 • Collected over one year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
5/92 • Number of events 5 • Collected over one year
|
2.2%
2/91 • Number of events 2 • Collected over one year
|
4.4%
4/90 • Number of events 4 • Collected over one year
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/92 • Number of events 2 • Collected over one year
|
4.4%
4/91 • Number of events 4 • Collected over one year
|
6.7%
6/90 • Number of events 6 • Collected over one year
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
3/92 • Number of events 3 • Collected over one year
|
1.1%
1/91 • Number of events 1 • Collected over one year
|
6.7%
6/90 • Number of events 6 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
10/92 • Number of events 10 • Collected over one year
|
9.9%
9/91 • Number of events 9 • Collected over one year
|
8.9%
8/90 • Number of events 8 • Collected over one year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
5/92 • Number of events 5 • Collected over one year
|
7.7%
7/91 • Number of events 7 • Collected over one year
|
7.8%
7/90 • Number of events 7 • Collected over one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place