Trial Outcomes & Findings for Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency (NCT NCT01651000)
NCT ID: NCT01651000
Last Updated: 2025-01-13
Results Overview
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
213 participants
Primary outcome timeframe
Approximately 6 months
Results posted on
2025-01-13
Participant Flow
This multicenter study was conducted at 44 investigational sites within the US. Subjects were enrolled and treated from 07 September 2012 through 20 July 2014.
Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).
Participant milestones
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
141
|
|
Overall Study
Entered Extension Study
|
50
|
93
|
|
Overall Study
COMPLETED
|
62
|
113
|
|
Overall Study
NOT COMPLETED
|
10
|
28
|
Reasons for withdrawal
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
10
|
|
Overall Study
Subject noncompliance
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Administrative reason
|
1
|
0
|
|
Overall Study
Serum Ca >/= 11.0 mg/dL, repeat confirm
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Baseline characteristics by cohort
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=141 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
141 participants
n=7 Participants
|
213 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 monthsPopulation: Intent to treat
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=141 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
|
6 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Per protocol
Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=62 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=115 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
|
5 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Intent to treat
Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL)
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=141 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
|
2 participants
|
113 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Per protocol
Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL)
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=62 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=115 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
|
2 participants
|
110 participants
|
Adverse Events
Sugar Pill to CTAP101 30 μg Capsule
Serious events: 12 serious events
Other events: 37 other events
Deaths: 0 deaths
CTAP101 30 μg Capsules
Serious events: 30 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=72 participants at risk
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=141 participants at risk
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/72 • Number of events 1 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Cardiac disorders
Arrhyhmia
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/72 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/72 • 6 months
|
4.3%
6/141 • Number of events 6 • 6 months
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
General disorders
Asthenia
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
General disorders
Chest pain
|
2.8%
2/72 • Number of events 2 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Infections and infestations
Cellulitis
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
1.4%
1/72 • Number of events 1 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/72 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/72 • 6 months
|
3.5%
5/141 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Nervous system disorders
Basal ganglia stroke
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Nervous system disorders
Presyncope
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/72 • Number of events 1 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Vascular disorders
Aortic intramural haematoma
|
1.4%
1/72 • Number of events 1 • 6 months
|
0.00%
0/141 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/72 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Sugar Pill to CTAP101 30 μg Capsule
n=72 participants at risk
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=141 participants at risk
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
12/72 • Number of events 12 • 6 months
|
4.3%
6/141 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
8.3%
6/72 • Number of events 6 • 6 months
|
2.1%
3/141 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
5/72 • Number of events 5 • 6 months
|
1.4%
2/141 • Number of events 2 • 6 months
|
|
General disorders
Oedema peripheral
|
6.9%
5/72 • Number of events 5 • 6 months
|
2.1%
3/141 • Number of events 3 • 6 months
|
|
General disorders
Chest pain
|
5.6%
4/72 • Number of events 4 • 6 months
|
2.1%
3/141 • Number of events 3 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
13.9%
10/72 • Number of events 10 • 6 months
|
5.0%
7/141 • Number of events 7 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
4/72 • Number of events 4 • 6 months
|
2.8%
4/141 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
4/72 • Number of events 4 • 6 months
|
2.8%
4/141 • Number of events 4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
6/72 • Number of events 6 • 6 months
|
4.3%
6/141 • Number of events 6 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
6/72 • Number of events 6 • 6 months
|
2.1%
3/141 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
4/72 • Number of events 4 • 6 months
|
2.1%
3/141 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
4/72 • Number of events 4 • 6 months
|
4.3%
6/141 • Number of events 6 • 6 months
|
|
Vascular disorders
Hypertension
|
6.9%
5/72 • Number of events 5 • 6 months
|
6.4%
9/141 • Number of events 9 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
4/72 • Number of events 4 • 6 months
|
0.71%
1/141 • Number of events 1 • 6 months
|
Additional Information
Douglass Laidlaw, PhD, Vice President, Medical Affairs
OPKO Health, Inc.
Phone: 305-575-4172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60