Trial Outcomes & Findings for A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD (NCT NCT00785629)
NCT ID: NCT00785629
Last Updated: 2012-10-30
Results Overview
mean serum phosphorus from months 3-9
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
months 3-9
Results posted on
2012-10-30
Participant Flow
Single center private practice single specialty clinic, Enrollment Feb 2009 thru September 2010
Consecutive CKD patients with eGFR 20- 45 ml/min with serum Phosphorus \>3.5 \< 6.0. Stratified by diabetic status. 3 subjects were enrolled but did not receive study medication due to withdrawal prior to starting medication.
Participant milestones
| Measure |
Calcium Acetate
phosphate binder : starting dose 667mg;titrations to 2668mg QAC
|
Sevelamer Carbonate
phosphate binder : starting dose 800mg; titrations to 3200mg QAC
|
Lanthanum Carbonate
phosphate binder : starting dose 500mg; titrations to 1500mg QAC
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
28
|
57
|
|
Overall Study
COMPLETED
|
22
|
25
|
18
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
10
|
16
|
Reasons for withdrawal
| Measure |
Calcium Acetate
phosphate binder : starting dose 667mg;titrations to 2668mg QAC
|
Sevelamer Carbonate
phosphate binder : starting dose 800mg; titrations to 3200mg QAC
|
Lanthanum Carbonate
phosphate binder : starting dose 500mg; titrations to 1500mg QAC
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
5
|
|
Overall Study
Protocol Violation
|
1
|
2
|
4
|
5
|
|
Overall Study
administrative decision
|
5
|
1
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
2
|
Baseline Characteristics
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
Baseline characteristics by cohort
| Measure |
Calcium Acetate
n=30 Participants
phosphate binder : starting dose 667mg;titrations to 2668mg QAC
|
Sevelamer Carbonate
n=30 Participants
phosphate binder : starting dose 800mg; titrations to 3200mg QAC
|
Lanthanum Carbonate
n=28 Participants
phosphate binder : starting dose 500mg; titrations to 1500mg QAC
|
Placebo
n=57 Participants
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
68 years
STANDARD_DEVIATION 12 • n=5 Participants
|
66 years
STANDARD_DEVIATION 12 • n=7 Participants
|
70 years
STANDARD_DEVIATION 10 • n=5 Participants
|
65 years
STANDARD_DEVIATION 12 • n=4 Participants
|
67 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
28 participants
n=5 Participants
|
57 participants
n=4 Participants
|
145 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: months 3-9Population: ITT analysis was ALL active patients combined versus all placebo patients combined
mean serum phosphorus from months 3-9
Outcome measures
| Measure |
All Active Treated Patients
n=88 Participants
All actively treated patients
|
All Placebo Treated Patients
n=57 Participants
All placebo treated patients
|
|---|---|---|
|
Serum Phosphorus
|
3.9 mg/dL
Standard Deviation 0.4
|
4.2 mg/dL
Standard Deviation 0.4
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Lanthanum Carbonate
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Sevelamer Carbonate
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Calcium Acetate
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
|
Lanthanum Carbonate
n=28 participants at risk
|
Sevelamer Carbonate
n=30 participants at risk
|
Calcium Acetate
n=30 participants at risk
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypothyroidism
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
Appendicitis
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
Peritoneal infection
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Injury, poisoning and procedural complications
Fracture
|
3.5%
2/57 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.5%
2/57 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Vascular disorders
Thromboembolic Event
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
Sepsis
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Vascular disorders
visceral arterial ischemia
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Vascular disorders
hypotension
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Surgical and medical procedures
Total knee replacement
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Surgical and medical procedures
Gastric lap banding
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
left ventricular systolic dysfunction
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
right ventricular dysfunction
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Eye disorders
vitreous hemorrhage
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Injury, poisoning and procedural complications
Other: digitalis toxicity
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Metabolism and nutrition disorders
hypergylcemia
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Nervous system disorders
altered mental status
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Nervous system disorders
stroke
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
|
Lanthanum Carbonate
n=28 participants at risk
|
Sevelamer Carbonate
n=30 participants at risk
|
Calcium Acetate
n=30 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
7.0%
4/57 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
conduction disorder
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
left ventricular systolic dysfuction
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Cardiac disorders
sinus bradycardia
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
|
Endocrine disorders
hyperparathyroidism
|
8.8%
5/57 • Number of events 5 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
13.3%
4/30 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
abdominal pain
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
constipation
|
3.5%
2/57 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
10.7%
3/28 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
23.3%
7/30 • Number of events 7 • Enrollment until 14 days post end of study (last dose)
|
20.0%
6/30 • Number of events 6 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
diarrhea
|
10.5%
6/57 • Number of events 6 • Enrollment until 14 days post end of study (last dose)
|
25.0%
7/28 • Number of events 7 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
dyspepsia
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
enterocolitis
|
7.0%
4/57 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
flatulence
|
3.5%
2/57 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
nausea
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
10.7%
3/28 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Gastrointestinal disorders
vomiting
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
21.4%
6/28 • Number of events 6 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
General disorders
edema limbs
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
pneumonia
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
sinusitis
|
7.0%
4/57 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
soft tissue infections
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
10.7%
3/28 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
upper respiratory infection
|
7.0%
4/57 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
14.3%
4/28 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
|
Infections and infestations
urinary tract infection
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
10.0%
3/30 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
13.3%
4/30 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
|
Injury, poisoning and procedural complications
fracture
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Metabolism and nutrition disorders
acidosis
|
10.5%
6/57 • Number of events 6 • Enrollment until 14 days post end of study (last dose)
|
10.7%
3/28 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Metabolism and nutrition disorders
hypercalcemia
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
16.7%
5/30 • Number of events 5 • Enrollment until 14 days post end of study (last dose)
|
|
Metabolism and nutrition disorders
hyperkalemia
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Metabolism and nutrition disorders
hypoglycemia
|
8.8%
5/57 • Number of events 5 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
14.0%
8/57 • Number of events 8 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
13.3%
4/30 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
7.0%
4/57 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
3.6%
1/28 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
|
Nervous system disorders
syncope
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
10.7%
3/28 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Renal and urinary disorders
acute kidney injury
|
14.0%
8/57 • Number of events 8 • Enrollment until 14 days post end of study (last dose)
|
25.0%
7/28 • Number of events 7 • Enrollment until 14 days post end of study (last dose)
|
13.3%
4/30 • Number of events 4 • Enrollment until 14 days post end of study (last dose)
|
23.3%
7/30 • Number of events 7 • Enrollment until 14 days post end of study (last dose)
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
3.5%
2/57 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/57 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
|
Skin and subcutaneous tissue disorders
other: laceration
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Skin and subcutaneous tissue disorders
pruritis
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
7.1%
2/28 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Skin and subcutaneous tissue disorders
rash- maculo-papular
|
5.3%
3/57 • Number of events 3 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
3.3%
1/30 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
|
Vascular disorders
hypotension
|
1.8%
1/57 • Number of events 1 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/28 • Enrollment until 14 days post end of study (last dose)
|
0.00%
0/30 • Enrollment until 14 days post end of study (last dose)
|
6.7%
2/30 • Number of events 2 • Enrollment until 14 days post end of study (last dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60