Trial Outcomes & Findings for Dynepo Long-Term Safety Study (NCT NCT00514813)
NCT ID: NCT00514813
Last Updated: 2021-07-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
152 participants
Primary outcome timeframe
Over the course of 2 Years
Results posted on
2021-07-13
Participant Flow
This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) at a dose that is appropriate for them and not to exceed 20,000 IU at any one time.
Participant milestones
| Measure |
Dynepo (Epoetin Delta) Twice Weekly (BIW)
Epoetin delta (Dynepo) dosed twice-a-week
|
Dynepo Once Weekly (QW)
Epoetin delta dosed once-a-week
|
Dynepo Once Every 2 Weeks (Q2W)
Epoetin delta dosed once every 2 weeks
|
Dynepo Once Every 4 Weeks (Q4W)
Epoetin delta dosed once every 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
86
|
47
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
86
|
47
|
4
|
Reasons for withdrawal
| Measure |
Dynepo (Epoetin Delta) Twice Weekly (BIW)
Epoetin delta (Dynepo) dosed twice-a-week
|
Dynepo Once Weekly (QW)
Epoetin delta dosed once-a-week
|
Dynepo Once Every 2 Weeks (Q2W)
Epoetin delta dosed once every 2 weeks
|
Dynepo Once Every 4 Weeks (Q4W)
Epoetin delta dosed once every 4 weeks
|
|---|---|---|---|---|
|
Overall Study
Study terminated
|
14
|
74
|
40
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Kidney transplant
|
0
|
6
|
2
|
0
|
|
Overall Study
Death
|
0
|
2
|
3
|
2
|
Baseline Characteristics
Dynepo Long-Term Safety Study
Baseline characteristics by cohort
| Measure |
Dynepo (Epoetin Delta) Twice Weekly (BIW)
n=15 Participants
Epoetin delta (Dynepo) dosed twice-a-week
|
Dynepo Once Weekly (QW)
n=86 Participants
Epoetin delta dosed once-a-week
|
Dynepo Once Every 2 Weeks (Q2W)
n=47 Participants
Epoetin delta dosed once every 2 weeks
|
Dynepo Once Every 4 Weeks (Q4W)
n=4 Participants
Epoetin delta dosed once every 4 weeks
|
Total
n=152 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 21.39 • n=4 Participants
|
64.9 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Over the course of 2 YearsPopulation: This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
Outcome measures
Outcome data not reported
Adverse Events
Dynepo (Epoetin Delta) Twice Weekly (BIW)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Dynepo Once Weekly (QW)
Serious events: 14 serious events
Other events: 62 other events
Deaths: 0 deaths
Dynepo Once Every 2 Weeks (Q2W)
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Dynepo Once Every 4 Weeks (Q4W)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dynepo (Epoetin Delta) Twice Weekly (BIW)
n=15 participants at risk
Epoetin delta (Dynepo) dosed twice-a-week
|
Dynepo Once Weekly (QW)
n=84 participants at risk
Epoetin delta dosed once-a-week
|
Dynepo Once Every 2 Weeks (Q2W)
n=47 participants at risk
Epoetin delta dosed once every 2 weeks
|
Dynepo Once Every 4 Weeks (Q4W)
n=4 participants at risk
Epoetin delta dosed once every 4 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Dialysis device complication
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Cardiac disorders
Acute MI
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Fecaloma
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
General disorders
Catheter-related complication
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
General disorders
Sudden death
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
Other adverse events
| Measure |
Dynepo (Epoetin Delta) Twice Weekly (BIW)
n=15 participants at risk
Epoetin delta (Dynepo) dosed twice-a-week
|
Dynepo Once Weekly (QW)
n=84 participants at risk
Epoetin delta dosed once-a-week
|
Dynepo Once Every 2 Weeks (Q2W)
n=47 participants at risk
Epoetin delta dosed once every 2 weeks
|
Dynepo Once Every 4 Weeks (Q4W)
n=4 participants at risk
Epoetin delta dosed once every 4 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.0%
5/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.8%
4/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
12.8%
6/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.0%
5/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
7.1%
6/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
General disorders
Edema peripheral
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
General disorders
Vessel puncture site hematoma
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Catheter site infection
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Influenza
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.0%
5/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
8.5%
4/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
7.1%
6/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.4%
2/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.4%
2/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.4%
3/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Dialysis device complication
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Injury, poisoning and procedural complications
Injury
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Investigations
Hemaglobin decreased
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
3.6%
3/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
3.6%
3/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.8%
4/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.0%
5/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
2.1%
1/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
3.6%
3/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
7.1%
6/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
1.2%
1/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
7.1%
6/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
4.3%
2/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
3.6%
3/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
6.4%
3/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
25.0%
1/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
|
Vascular disorders
Orthostatic hypertension
|
6.7%
1/15
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/84
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/47
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
0.00%
0/4
The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER