Trial Outcomes & Findings for An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis (NCT NCT01940484)
NCT ID: NCT01940484
Last Updated: 2017-07-05
Results Overview
Recruitment status
COMPLETED
Target enrollment
98 participants
Primary outcome timeframe
Visit 2 (Month 1)
Results posted on
2017-07-05
Participant Flow
Participant milestones
| Measure |
Chronic Renal Anemia Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Chronic Renal Anemia Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Underwent transplantation
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis
Baseline characteristics by cohort
| Measure |
Chronic Renal Anemia Participants
n=98 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 15.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
|
Diastolic blood pressure (DBP)
DBP pre-dialysis (n=95)
|
82.5 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 13.6 • n=93 Participants
|
|
Diastolic blood pressure (DBP)
DBP post-dialysis (n=93)
|
78.8 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 13.8 • n=93 Participants
|
|
Systolic Blood Pressure (SBP)
SBP pre-dialysis (n=95)
|
145.7 mm Hg
STANDARD_DEVIATION 18.8 • n=93 Participants
|
|
Systolic Blood Pressure (SBP)
SBP post-dialysis (n=93)
|
136.7 mm Hg
STANDARD_DEVIATION 19.6 • n=93 Participants
|
|
Pulse rate
|
73.4 beats per minute
STANDARD_DEVIATION 13.1 • n=93 Participants
|
|
Height
|
167.5 centimeters (cm)
STANDARD_DEVIATION 10.3 • n=93 Participants
|
|
Body Weight
|
75.0 kilograms
STANDARD_DEVIATION 18.5 • n=93 Participants
|
|
Number of Participants With Hemoglobin Level Within the Range of 11-12 Grams Per Deciliter (g/dL)
|
25 participants
n=93 Participants
|
|
Mean Hemoglobin Value
|
11.57 g/dL
STANDARD_DEVIATION 1.47 • n=93 Participants
|
|
Methoxy Polyethylene Glycol-Epoetin Beta Dose
|
107.47 micrograms (mcg)
STANDARD_DEVIATION 41.80 • n=93 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Month 1)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=87 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
|
23 participants
|
PRIMARY outcome
Timeframe: Visit 3 (Month 2)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=89 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
|
26 participants
|
PRIMARY outcome
Timeframe: Visit 4 (Month 3)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=86 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
|
22 participants
|
PRIMARY outcome
Timeframe: Visit 5 (Month 4)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=83 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
|
17 participants
|
PRIMARY outcome
Timeframe: Visit 6 (Month 5)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=86 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
|
24 participants
|
PRIMARY outcome
Timeframe: Visit 7 (Month 6)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=78 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
|
24 participants
|
PRIMARY outcome
Timeframe: Visit 2 (Month 1)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=87 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 2 (Month 1)
|
11.31 g/dL
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: Visit 3 (Month 2)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=89 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 3 (Month 2)
|
10.81 g/dL
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: Visit 4 (Month 3)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=86 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 4 (Month 3)
|
10.61 g/dL
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: Visit 5 (Month 4)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=83 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 5 (Month 4)
|
10.80 g/dL
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: Visit 6 (Month 5)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=86 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 6 (Month 5)
|
10.82 g/dL
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Visit 7 (Month 6)Population: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=78 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Hemoglobin Value at Visit 7 (Month 6)
|
10.94 g/dL
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)Population: Included all enrolled participants who were evaluable for this outcome measure and "n" represents number of participants evaluable at the specified time point.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=91 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 2 (n=91)
|
106.59 mcg
Standard Deviation 42.79
|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 3 (n=87)
|
108.91 mcg
Standard Deviation 39.80
|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 4 (n=90)
|
117.38 mcg
Standard Deviation 46.53
|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 5 (n=89)
|
122.47 mcg
Standard Deviation 49.72
|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 6 (n=85)
|
127.35 mcg
Standard Deviation 47.50
|
|
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Visit 7 (n=83)
|
133.73 mcg
Standard Deviation 50.67
|
SECONDARY outcome
Timeframe: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)Population: Included all enrolled participants who were evaluable for this outcome measure.
Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.
Outcome measures
| Measure |
Chronic Renal Anemia Participants
n=97 Participants
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 5-Decreased (n=90)
|
4 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 2-Decreased (n=97)
|
0 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 2-Increased (n=97)
|
0 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 3-Decreased (n=91)
|
6 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 3-Increased (n=91)
|
4 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 4-Decreased (n=86)
|
1 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 4-Increased (n=86)
|
7 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 5-Increased (n=90)
|
18 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 6-Decreased (n=88)
|
3 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 6-Increased (n=88)
|
16 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 7-Decreased (n=85)
|
2 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 7-Increased (n=85)
|
11 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 8-Decreased (n=81)
|
4 participants
|
|
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Visit 8-Increased (n=81)
|
11 participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Due to observational nature of the study, the data for this outcome measure could not be collected.
Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.
Outcome measures
Outcome data not reported
Adverse Events
Chronic Renal Anemia Participants
Serious events: 79 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Renal Anemia Participants
n=98 participants at risk
Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.1%
4/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Vascular disorders
Arteriovenous fistula thrombosis
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Bradycardia
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Transient ischaemic attack
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Vascular disorders
Vascular access complication
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Surgical and medical procedures
Catheter placement
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Surgical and medical procedures
Nephrectomy
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
BK virus infection
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Cholecystitis acute
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Colitis
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Duodenitis
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Gastritis
|
3.1%
3/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Gastroduodenitis
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Helicobacter infection
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Infection
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Liver abscess
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Otitis media
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Pneumonia
|
4.1%
4/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Pyelonephritis acute
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Sepsis
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Septic shock
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Tuberculosis
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
General disorders
Chest pain
|
3.1%
3/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
General disorders
Death
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
General disorders
Medical device complication
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Renal and urinary disorders
Renal pain
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Renal and urinary disorders
Renal mass
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Psychiatric disorders
Depression
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Headache
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
2/98 • Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER