Trial Outcomes & Findings for A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis (NCT NCT01519947)
NCT ID: NCT01519947
Last Updated: 2019-06-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
Up to approximately 20 months
Results posted on
2019-06-19
Participant Flow
87 participants were enrolled in the study. One participant did not receive study drug.
Participant milestones
| Measure |
Pre-dialysis, Sea Level
Participants received 50-250 mcg subcutaneously (SC) according to local label.
|
Dialysis, Sea Level
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
15
|
42
|
|
Overall Study
COMPLETED
|
17
|
7
|
8
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
7
|
8
|
Reasons for withdrawal
| Measure |
Pre-dialysis, Sea Level
Participants received 50-250 mcg subcutaneously (SC) according to local label.
|
Dialysis, Sea Level
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
1
|
|
Overall Study
Peritoneal Dialysis Needed
|
0
|
1
|
0
|
0
|
|
Overall Study
Development of Anemia
|
0
|
1
|
0
|
1
|
|
Overall Study
Blood Transfusion
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
2
|
|
Overall Study
Poor Response
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
Baseline Characteristics
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
Baseline characteristics by cohort
| Measure |
Pre-dialysis, Sea Level
n=19 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 Participants
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 Participants
Participants received 50-250 mcg SC according to local label.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 18.8 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 17.4 • n=4 Participants
|
56.2 years
STANDARD_DEVIATION 17.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 20 monthsPopulation: The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.
Outcome measures
| Measure |
Pre-dialysis, Sea Level
n=19 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 Participants
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 Participants
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
|
150.3 micrograms (mcg)
Standard Deviation 69.0
|
194.7 micrograms (mcg)
Standard Deviation 214.2
|
98.7 micrograms (mcg)
Standard Deviation 22.5
|
66.6 micrograms (mcg)
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsPopulation: The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. Data are reported for evaluable participants.
Outcome measures
| Measure |
Pre-dialysis, Sea Level
n=19 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=3 Participants
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=8 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=34 Participants
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Change in Hemoglobin Concentration
|
1.4 grams per deciliter (g/dL)
Standard Deviation 0.8
|
2.5 grams per deciliter (g/dL)
Standard Deviation 1.5
|
2.0 grams per deciliter (g/dL)
Standard Deviation 0.8
|
2.4 grams per deciliter (g/dL)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.
Outcome measures
| Measure |
Pre-dialysis, Sea Level
n=19 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 Participants
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 Participants
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
3 months
|
36.8 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
6 months
|
52.6 percentage of participants
|
0.0 percentage of participants
|
13.3 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 20 monthsPopulation: The safety population included all enrolled participants who received at least one dose of study drug and had a subsequent safety evaluation dose.
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Pre-dialysis, Sea Level
n=19 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 Participants
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 Participants
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 Participants
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
84.2 percentage of participants
|
90.0 percentage of participants
|
66.7 percentage of participants
|
85.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 20 monthsPopulation: Data were not collected.
This outcome measure was not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 20 monthsPopulation: Data were not collected.
This outcome measure was not assessed.
Outcome measures
Outcome data not reported
Adverse Events
Pre-dialysis, Sea Level
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Dialysis, Sea Level
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Pre-dialysis, >1800 Meters
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Dialysis, >1800 Meters
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-dialysis, Sea Level
n=19 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 participants at risk
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Cardiac disorders
Pulmonary oedema
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
General disorders
Collapse cardiovascular
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Hepatobiliary disorders
Malignant neoplasm of ampulla of Vater
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Infusion site infection
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Vascular disorders
Cerebral thrombosis
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
Other adverse events
| Measure |
Pre-dialysis, Sea Level
n=19 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Dialysis, Sea Level
n=10 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Pre-dialysis, >1800 Meters
n=15 participants at risk
Participants received 50-250 mcg SC according to local label.
|
Dialysis, >1800 Meters
n=42 participants at risk
Participants received 50-250 mcg SC according to local label.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.3%
1/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Cardiac disorders
Dyspnoea
|
5.3%
1/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Cardiac disorders
Pericardial effusion
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Cardiac disorders
Ventricular hypertrophy
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Endocrine disorders
Hyperglycaemia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
9.5%
4/42 • Up to approximately 20 months
|
|
Endocrine disorders
Hypoglycaemia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
20.0%
3/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Endocrine disorders
Diabetic retinopathy
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Eye disorders
Conjunctivitis
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Eye disorders
Eyelid oedema
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Up to approximately 20 months
|
20.0%
2/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/19 • Up to approximately 20 months
|
30.0%
3/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
2/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Haematochezia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
General disorders
Asthenia
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
20.0%
3/15 • Up to approximately 20 months
|
19.0%
8/42 • Up to approximately 20 months
|
|
General disorders
Catheter related infection
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
General disorders
Face oedema
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
General disorders
Oedema
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Up to approximately 20 months
|
20.0%
2/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
16.7%
7/42 • Up to approximately 20 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Infusion site infection
|
0.00%
0/19 • Up to approximately 20 months
|
20.0%
2/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Chest injury
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Investigations
Serum ferritin increased
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
16.7%
7/42 • Up to approximately 20 months
|
|
Investigations
Transferrin saturation decreased
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Investigations
Blood iron decreased
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
36.8%
7/19 • Up to approximately 20 months
|
20.0%
2/10 • Up to approximately 20 months
|
26.7%
4/15 • Up to approximately 20 months
|
19.0%
8/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Oedema
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
14.3%
6/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
14.3%
6/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Generalised oedema
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
9.5%
4/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
9.5%
4/42 • Up to approximately 20 months
|
|
Nervous system disorders
Vertigo
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
9.5%
4/42 • Up to approximately 20 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Dysuria
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Renal disorder
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.3%
1/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Reproductive system and breast disorders
Lipoma of breast
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Reproductive system and breast disorders
Prostatism
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
10.5%
2/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
4.8%
2/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngotonsillitis
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
20.0%
3/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Skin and subcutaneous tissue disorders
Pallor
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
19.0%
8/42 • Up to approximately 20 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
2.4%
1/42 • Up to approximately 20 months
|
|
Surgical and medical procedures
Eye operation
|
0.00%
0/19 • Up to approximately 20 months
|
0.00%
0/10 • Up to approximately 20 months
|
6.7%
1/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
|
Vascular disorders
Hypertension
|
31.6%
6/19 • Up to approximately 20 months
|
40.0%
4/10 • Up to approximately 20 months
|
13.3%
2/15 • Up to approximately 20 months
|
45.2%
19/42 • Up to approximately 20 months
|
|
Vascular disorders
Ecchymosis
|
0.00%
0/19 • Up to approximately 20 months
|
10.0%
1/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
7.1%
3/42 • Up to approximately 20 months
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/19 • Up to approximately 20 months
|
20.0%
2/10 • Up to approximately 20 months
|
0.00%
0/15 • Up to approximately 20 months
|
0.00%
0/42 • Up to approximately 20 months
|
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