Trial Outcomes & Findings for Use of NPSP558 in the Treatment of Hypoparathyroidism (NCT NCT00732615)
NCT ID: NCT00732615
Last Updated: 2021-06-03
Results Overview
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
Week 24 of dosing
Results posted on
2021-06-03
Participant Flow
124 Subjects were enrolled between 12/2008 and 9/2011 at 28 clinical sites in North America, Western Europe and Hungary.
Subjects underwent a screening and stabilization period (optimization) of up to 16 weeks prior to enrollment. Please note: Data for 10 subjects were excluded.
Participant milestones
| Measure |
Placebo
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
84
|
|
Overall Study
COMPLETED
|
33
|
79
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Non-Compliance, Subject/Physician Dec.
|
1
|
1
|
Baseline Characteristics
Use of NPSP558 in the Treatment of Hypoparathyroidism
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=84 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
13 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
23 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
21 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24 of dosingPopulation: Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.
Outcome measures
| Measure |
Placebo
n=40 Participants
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=84 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|---|
|
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
54.8 percentage of participants
Interval 43.5 to 65.7
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Intent to Treat (ITT) population subjects with Baseline and Week 24 data
The analysis of this endpoint was based on investigator prescribed data.
Outcome measures
| Measure |
Placebo
n=33 Participants
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=79 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|---|
|
Percentage Changes From Baseline in Daily Calcium Dose at Week 24.
|
2.4 percentage change from baseline
Standard Deviation 38.37
|
-51.8 percentage change from baseline
Standard Deviation 45.71
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Intent to Treat (ITT) population subjects with Baseline and Week 24 data.
Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.
Outcome measures
| Measure |
Placebo
n=33 Participants
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=79 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|---|
|
Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.
|
6.1 percentage of participants
|
43.0 percentage of participants
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: Intent to Treat (ITT) population.
Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.
Outcome measures
| Measure |
Placebo
n=40 Participants
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=84 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|---|
|
Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.
|
37.5 percentage of participants
|
34.5 percentage of participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
NPSP558
Serious events: 9 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=84 participants at risk
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
2.4%
2/84 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
2.4%
2/84 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Erysipelas
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
1.2%
1/84 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
2.5%
1/40 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
1/40 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
1/40 • Number of events 1 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Matching Placebo: Placebo for subcutaneous injection
|
NPSP558
n=84 participants at risk
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily
|
|---|---|---|
|
Nervous system disorders
Paraesthesia
|
25.0%
10/40 • Number of events 16 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
35.7%
30/84 • Number of events 69 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
22.5%
9/40 • Number of events 10 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
39.3%
33/84 • Number of events 54 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
30.0%
12/40 • Number of events 21 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
29.8%
25/84 • Number of events 41 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • Number of events 9 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
20.2%
17/84 • Number of events 35 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
9.5%
8/84 • Number of events 8 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
General disorders
Fatigue
|
20.0%
8/40 • Number of events 11 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
11.9%
10/84 • Number of events 25 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
7.1%
6/84 • Number of events 6 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Nervous system disorders
Headache
|
25.0%
10/40 • Number of events 20 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
26.2%
22/84 • Number of events 56 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
5/40 • Number of events 6 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
19.0%
16/84 • Number of events 24 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
4/40 • Number of events 4 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
16.7%
14/84 • Number of events 17 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Tetany
|
10.0%
4/40 • Number of events 13 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
11.9%
10/84 • Number of events 24 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
5/40 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
11.9%
10/84 • Number of events 18 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
10.7%
9/84 • Number of events 13 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
7/40 • Number of events 8 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
9.5%
8/84 • Number of events 8 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
7.1%
6/84 • Number of events 13 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • Number of events 4 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
11.9%
10/84 • Number of events 13 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
11.9%
10/84 • Number of events 12 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Paraesthesia oral
|
7.5%
3/40 • Number of events 6 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
8.3%
7/84 • Number of events 7 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
8.3%
7/84 • Number of events 9 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
7.1%
6/84 • Number of events 7 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Investigations
Blood 25-hydroxycholecalciferol decreased
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/40 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
6.0%
5/84 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Number of events 4 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Nervous system disorders
Dysgeusia
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
10.0%
4/40 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.5%
3/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
5/40 • Number of events 5 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Cystitis
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Herpes Zoster
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Infections and infestations
Viral Infection
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
General disorders
Injection Site Haematoma
|
12.5%
5/40 • Number of events 6 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
General disorders
Feeling Cold
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
General disorders
Oedema Peripheral
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Investigations
Urine Calcium Increased
|
5.0%
2/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40 • Number of events 3 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
5.0%
2/40 • Number of events 2 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
0.00%
0/84 • 28 weeks
24 weeks on treatment plus 4 week follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER