Trial Outcomes & Findings for A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin (NCT NCT01628120)
NCT ID: NCT01628120
Last Updated: 2019-03-18
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
170 participants
Primary outcome timeframe
Up through 7 days after first dose of study drug (Week 1)
Results posted on
2019-03-18
Participant Flow
Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-13 (NCT01473420) prior to enrollment and treatment in the current study.
Participant milestones
| Measure |
Epoetin Hospira
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Overall Study
STARTED
|
173
|
|
Overall Study
Treated
|
170
|
|
Overall Study
COMPLETED
|
129
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Epoetin Hospira
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Not met Inclusion/Exclusion Criteria
|
2
|
|
Overall Study
Non-compliant with Study Procedures
|
1
|
|
Overall Study
Not Treated
|
3
|
|
Overall Study
Sponsor Decision
|
5
|
|
Overall Study
Switched Dialysis Method
|
2
|
|
Overall Study
Missed Study Drug More than 2 Weeks
|
3
|
|
Overall Study
Moved or Relocated
|
5
|
|
Overall Study
Kidney Transplant
|
2
|
|
Overall Study
Use of Standard of Care
|
1
|
Baseline Characteristics
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
Baseline characteristics by cohort
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Age, Continuous
|
56.63 years
STANDARD_DEVIATION 12.903 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up through 7 days after first dose of study drug (Week 1)Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=167 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
|
17.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 1 up to Week 12Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
|
67.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 13 up to Week 24Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=157 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
|
60.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 25 up to Week 36Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=145 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
|
57.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 37 up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=134 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
|
48.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 1 up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
|
87.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1 up to Week 48Population: Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
|
83.74 Unit per kilogram per week (U/kg/week)
Standard Deviation 93.983
|
SECONDARY outcome
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
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Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Week 1 to Week 12
|
80.49 U/kg/week
Standard Deviation 86.310
|
|
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Week 13 to Week 24
|
83.14 U/kg/week
Standard Deviation 94.060
|
|
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Week 25 to Week 36
|
85.98 U/kg/week
Standard Deviation 98.414
|
|
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Week 37 to Week 48
|
88.86 U/kg/week
Standard Deviation 120.284
|
SECONDARY outcome
Timeframe: Week 1 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Mean Hemoglobin Levels: Over Week 1 to 48
|
10.24 g/dL
Standard Deviation 0.553
|
SECONDARY outcome
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Mean Hemoglobin Levels for Interval of 12 Weeks
Week 1 to Week 12
|
10.16 g/dL
Standard Deviation 0.735
|
|
Mean Hemoglobin Levels for Interval of 12 Weeks
Week 13 to Week 24
|
10.28 g/dL
Standard Deviation 0.636
|
|
Mean Hemoglobin Levels for Interval of 12 Weeks
Week 25 to Week 36
|
10.30 g/dL
Standard Deviation 0.717
|
|
Mean Hemoglobin Levels for Interval of 12 Weeks
Week 37 to Week 48
|
10.25 g/dL
Standard Deviation 0.791
|
SECONDARY outcome
Timeframe: Week 1 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.
Hematocrit is defined as the percentage of red blood cells in the blood.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Mean Hematocrit Levels: Over Week 1 to 48
|
32.22 Percentage of red blood cells
Standard Deviation 2.091
|
SECONDARY outcome
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points.
Hematocrit is defined as the percentage of red blood cells in the blood.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Mean Hematocrit Levels for Interval of 12 Weeks
Week 1 to Week 12
|
31.90 Percentage of red blood cells
Standard Deviation 2.516
|
|
Mean Hematocrit Levels for Interval of 12 Weeks
Week 13 to Week 24
|
32.32 Percentage of red blood cells
Standard Deviation 2.358
|
|
Mean Hematocrit Levels for Interval of 12 Weeks
Week 25 to Week 36
|
32.40 Percentage of red blood cells
Standard Deviation 2.657
|
|
Mean Hematocrit Levels for Interval of 12 Weeks
Week 37 to Week 48
|
32.31 Percentage of red blood cells
Standard Deviation 2.851
|
SECONDARY outcome
Timeframe: Week 1 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.
Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Hemoglobin Level Outside Target Range
|
86.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1 up to Week 48Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants Who Received Blood Transfusions
|
8.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
|
13.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Epoetin Hospira
n=169 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
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|---|---|
|
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
|
20.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Number of Participants Who Received Concomitant Medication
|
170 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "n" signifies those participants who were evaluable at specified time points.
Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.
Outcome measures
| Measure |
Epoetin Hospira
n=170 Participants
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies
Baseline
|
0.6 Percentage of participants
|
|
Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies
Week 48
|
0.7 Percentage of participants
|
Adverse Events
Epoetin Hospira
Serious events: 59 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Hospira
n=170 participants at risk
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Arrhythmia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Bradycardia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Bundle branch block left
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Cardiac arrest
|
1.8%
3/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.5%
6/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Nodal rhythm
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Eye disorders
Optic neuropathy
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Appendicitis perforated
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Cellulitis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Influenza
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Pneumonia
|
2.9%
5/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Respiratory tract infection
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Septic shock
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.8%
3/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Sepsis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Staphylococcal infection
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Streptococcal sepsis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.8%
3/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
1/75
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Headache
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Syncope
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Renal and urinary disorders
Azotaemia
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
3/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.59%
1/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
Other adverse events
| Measure |
Epoetin Hospira
n=170 participants at risk
Participants were enrolled to receive Epoetin Hospira subcutaneous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL).
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.9%
27/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Nausea
|
15.9%
27/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Headache
|
14.7%
25/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
21/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
18/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
18/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Dizziness
|
10.0%
17/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Hypotension
|
10.0%
17/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
16/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
14/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
14/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
7.6%
13/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
13/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
13/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
13/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
11/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
6.5%
11/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Psychiatric disorders
Anxiety
|
5.9%
10/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
10/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
9/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Oedema peripheral
|
5.3%
9/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Pain
|
5.3%
9/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Pyrexia
|
5.3%
9/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
5.3%
9/170
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
Additional Information
Pfizer, Inc.
Pfizer ClinicalTrials.gov Call Center
Phone: 1--800--718--1021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single centre publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER