Trial Outcomes & Findings for Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis (NCT NCT00548249)
NCT ID: NCT00548249
Last Updated: 2020-12-02
Results Overview
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
up to 26 weeks
Results posted on
2020-12-02
Participant Flow
131 patients randomized and dosed between 27 Aug 2007 and 28 Apr 2009, across 29 study sites in U.S. and Canada.
No run-in or transition.
Participant milestones
| Measure |
0 µg Iron/dL of Dialysate
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
29
|
22
|
28
|
|
Overall Study
COMPLETED
|
10
|
13
|
9
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
20
|
13
|
21
|
Reasons for withdrawal
| Measure |
0 µg Iron/dL of Dialysate
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Overall Study
Hemoglobin (Hgb) decrease >=1.0 g/dL
|
3
|
4
|
4
|
2
|
4
|
|
Overall Study
Transferrin Saturation (TSAT) <20%
|
5
|
1
|
3
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
4
|
0
|
3
|
|
Overall Study
Miscellaneous
|
2
|
3
|
2
|
0
|
2
|
|
Overall Study
Pre-dialysis (Pre-HD) TSAT >=50%
|
0
|
0
|
2
|
1
|
4
|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
1
|
1
|
|
Overall Study
Post-dialysis high TSAT or low UIBC
|
0
|
0
|
1
|
3
|
2
|
|
Overall Study
Erythropoietin (ESA)Dose Change Required
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Hemoglobin (Hgb) >= 12.6 g/dL
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
Prolonged hospitalization
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Corrected Q-wave T-wave (QTc) increase
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Sponsor's request
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
Baseline characteristics by cohort
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
Total
n=131 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 15.48 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 12.79 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 16.96 • n=21 Participants
|
58 years
STANDARD_DEVIATION 14.07 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
81 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
25 participants
n=5 Participants
|
21 participants
n=4 Participants
|
25 participants
n=21 Participants
|
117 participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
14 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 26 weeksPopulation: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
Outcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.
|
5 Percent of subjects
|
6 Percent of subjects
Interval 0.3 to 3.32
|
5 Percent of subjects
Interval 0.33 to 4.09
|
4 Percent of subjects
Interval 0.21 to 3.02
|
10 Percent of subjects
Interval 0.6 to 5.19
|
SECONDARY outcome
Timeframe: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
Outcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hgb)
|
-0.177 grams/ deciliter (g/dL)
Standard Deviation 1.1151
|
0.258 grams/ deciliter (g/dL)
Standard Deviation 1.4643
|
0.462 grams/ deciliter (g/dL)
Standard Deviation 1.2214
|
0.173 grams/ deciliter (g/dL)
Standard Deviation 1.5806
|
-0.018 grams/ deciliter (g/dL)
Standard Deviation 1.2532
|
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication. Because of the small number of patients reaching the endpoint of decrease in Hgb \>= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher.
Kaplan-Meier Estimate of Time to First Hgb Decrease by \>= 1.0 g/dL
Outcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
25th Percentile
|
115 Days
|
108 Days
|
115 Days
|
150 Days
|
94 Days
|
|
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
5th Percentile
|
59 Days
0.3267
|
24 Days
0.6674
|
10 Days
0.4402
|
31 Days
0.3697
|
31 Days
0.6609
|
|
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
10th Percentile
|
94 Days
|
31 Days
|
106 Days
|
45 Days
|
31 Days
|
|
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
15th Percentile
|
94 Days
|
66 Days
|
106 Days
|
115 Days
|
38 Days
|
|
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
20th Percentile
|
115 Days
|
87 Days
|
106 Days
|
115 Days
|
80 Days
|
SECONDARY outcome
Timeframe: Every 4 weeksPopulation: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).
Outcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Baseline Reticulocyte Hemoglobin
|
32.55 pg
Standard Deviation 2.084
|
32.98 pg
Standard Deviation 1.763
|
32.86 pg
Standard Deviation 3.192
|
32.34 pg
Standard Deviation 2.975
|
32.64 pg
Standard Deviation 1.858
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 1
|
32.42 pg
Standard Deviation 2.852
|
32.58 pg
Standard Deviation 1.932
|
32.69 pg
Standard Deviation 3.019
|
31.87 pg
Standard Deviation 2.963
|
32.40 pg
Standard Deviation 2.006
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 4
|
32.00 pg
Standard Deviation 2.668
|
32.27 pg
Standard Deviation 2.090
|
32.69 pg
Standard Deviation 2.931
|
31.82 pg
Standard Deviation 2.515
|
32.05 pg
Standard Deviation 1.837
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 8
|
32.14 pg
Standard Deviation 2.664
|
32.28 pg
Standard Deviation 2.135
|
32.75 pg
Standard Deviation 2.985
|
31.75 pg
Standard Deviation 2.473
|
32.35 pg
Standard Deviation 1.917
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 12
|
31.83 pg
Standard Deviation 2.347
|
32.13 pg
Standard Deviation 1.792
|
32.78 pg
Standard Deviation 1.560
|
31.82 pg
Standard Deviation 3.150
|
32.48 pg
Standard Deviation 1.894
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 16
|
31.45 pg
Standard Deviation 2.546
|
31.95 pg
Standard Deviation 1.866
|
33.05 pg
Standard Deviation 2.396
|
31.86 pg
Standard Deviation 3.410
|
32.25 pg
Standard Deviation 2.382
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 20
|
31.13 pg
Standard Deviation 2.172
|
31.81 pg
Standard Deviation 1.860
|
32.81 pg
Standard Deviation 2.328
|
30.68 pg
Standard Deviation 2.026
|
31.64 pg
Standard Deviation 1.338
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 24
|
30.93 pg
Standard Deviation 2.127
|
31.85 pg
Standard Deviation 1.820
|
32.08 pg
Standard Deviation 2.680
|
30.53 pg
Standard Deviation 2.071
|
31.40 pg
Standard Deviation 1.949
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Week 26
|
30.78 pg
Standard Deviation 2.638
|
31.32 pg
Standard Deviation 2.404
|
32.20 pg
Standard Deviation 2.372
|
30.72 pg
Standard Deviation 2.515
|
30.43 pg
Standard Deviation 2.600
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ End of Trial
|
30.06 pg
Standard Deviation 1.841
|
31.50 pg
Standard Deviation 2.348
|
31.46 pg
Standard Deviation 2.352
|
30.55 pg
Standard Deviation 2.523
|
30.11 pg
Standard Deviation 2.361
|
|
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Reticulocyte Hemoglobin/ Final Evaluation
|
31.85 pg
Standard Deviation 2.796
|
31.68 pg
Standard Deviation 2.386
|
32.19 pg
Standard Deviation 3.026
|
31.65 pg
Standard Deviation 3.409
|
32.13 pg
Standard Deviation 2.246
|
SECONDARY outcome
Timeframe: At each dialysis session for up to 26 weeksOutcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: two separate sessions measured one week apart.Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
Outcome measures
| Measure |
0 µg Iron/dL of Dialysate
n=26 Participants
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 Participants
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 Participants
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 Participants
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 Participants
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
|
6 Subjects
|
6 Subjects
Interval 0.33 to 3.17
|
9 Subjects
Interval 0.67 to 5.32
|
7 Subjects
Interval 0.48 to 4.22
|
8 Subjects
Interval 0.43 to 3.6
|
Adverse Events
0 µg Iron/dL of Dialysate
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
5 µg Iron/dL of Dialysate
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
10 µg Iron/dL of Dialysate
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
12 µg Iron/dL of Dialysate
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
15 µg Iron/dL of Dialysate
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0 µg Iron/dL of Dialysate
n=26 participants at risk
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 participants at risk
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 participants at risk
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 participants at risk
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 participants at risk
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Eye disorders
Eyelid oedema
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Catheter bacteraemia
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Nervous system disorders
Cognitive disorder
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
Other adverse events
| Measure |
0 µg Iron/dL of Dialysate
n=26 participants at risk
Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
5 µg Iron/dL of Dialysate
n=26 participants at risk
5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
10 µg Iron/dL of Dialysate
n=29 participants at risk
10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
12 µg Iron/dL of Dialysate
n=22 participants at risk
12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
15 µg Iron/dL of Dialysate
n=28 participants at risk
15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
3/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
24.1%
7/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
14.3%
4/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
6.9%
2/29 • Up to 26 weeks
|
27.3%
6/22 • Up to 26 weeks
|
14.3%
4/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
6.9%
2/29 • Up to 26 weeks
|
18.2%
4/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
6.9%
2/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Oedema peripheral
|
19.2%
5/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Fatigue
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Asthenia
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Chest discomfort
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Chest pain
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
General disorders
Chills
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
General disorders
Feeling hot
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Immune system disorders
Seasonal allergy
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
13.6%
3/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Infections and infestations
Bacteraemia
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • Up to 26 weeks
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
7.7%
2/26 • Up to 26 weeks
|
15.4%
4/26 • Up to 26 weeks
|
17.2%
5/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
14.3%
4/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
3.8%
1/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Infections and infestations
Contusion
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
10.3%
3/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
10.3%
3/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.8%
1/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.8%
1/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Investigations
Serum ferritin increased
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Investigations
Blood iron decreased
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Investigations
Iron binding capacity unsaturated decreased
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
4/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
13.8%
4/29 • Up to 26 weeks
|
13.6%
3/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
3/26 • Up to 26 weeks
|
7.7%
2/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
10.7%
3/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Up to 26 weeks
|
7.7%
2/26 • Up to 26 weeks
|
6.9%
2/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
9.1%
2/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
2/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Up to 26 weeks
|
7.7%
2/26 • Up to 26 weeks
|
17.2%
5/29 • Up to 26 weeks
|
13.6%
3/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Up to 26 weeks
|
11.5%
3/26 • Up to 26 weeks
|
13.8%
4/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.5%
3/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
10.3%
3/29 • Up to 26 weeks
|
18.2%
4/22 • Up to 26 weeks
|
7.1%
2/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.5%
3/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
4.5%
1/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
6.9%
2/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Up to 26 weeks
|
0.00%
0/26 • Up to 26 weeks
|
0.00%
0/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
3.6%
1/28 • Up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • Up to 26 weeks
|
3.8%
1/26 • Up to 26 weeks
|
3.4%
1/29 • Up to 26 weeks
|
0.00%
0/22 • Up to 26 weeks
|
0.00%
0/28 • Up to 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place