Trial Outcomes & Findings for Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy (NCT NCT00975221)

NCT ID: NCT00975221

Last Updated: 2018-10-17

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

67 participants

Primary outcome timeframe

Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)

Results posted on

2018-10-17

Participant Flow

The study was conducted at 29 centers in United States, Australia, Canada, Hungary, Poland, Portugal, and Russian Federation. The first participant enrolled on 10 March 2010 and the last participant enrolled on 28 December 2011.

This study consisted of a 12-week placebo-controlled dose-titration phase, a 16-week placebo-controlled efficacy assessment phase (EAP), and an open-label safety extension phase for 24 weeks of cinacalcet treatment. Participants were randomized in a 1:1 ratio to cinacalcet or placebo stratified by bisphosphonate use.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Titration Phase (Weeks 1-12) STARTED	34	33
Titration Phase (Weeks 1-12) Received Study Drug	34	33
Titration Phase (Weeks 1-12) COMPLETED	31	29
Titration Phase (Weeks 1-12) NOT COMPLETED	3	4
Efficacy Assessment Phase (Weeks 13-28) STARTED	30	29
Efficacy Assessment Phase (Weeks 13-28) COMPLETED	30	28
Efficacy Assessment Phase (Weeks 13-28) NOT COMPLETED	0	1
Open-label Extension Phase (Weeks 29-52) STARTED	29	28
Open-label Extension Phase (Weeks 29-52) COMPLETED	27	27
Open-label Extension Phase (Weeks 29-52) NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Titration Phase (Weeks 1-12) Withdrawal by Subject	2	3
Titration Phase (Weeks 1-12) Requirement for alternative therapy	1	0
Titration Phase (Weeks 1-12) Other	0	1
Efficacy Assessment Phase (Weeks 13-28) Lost to Follow-up	0	1
Open-label Extension Phase (Weeks 29-52) Adverse Event	1	1
Open-label Extension Phase (Weeks 29-52) Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=34 Participants Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet n=33 Participants Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Total n=67 Participants Total of all reporting groups
Age, Continuous	75.0 years STANDARD_DEVIATION 8.9 • n=5 Participants	69.5 years STANDARD_DEVIATION 13.0 • n=7 Participants	72.3 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	33 participants n=5 Participants	28 participants n=7 Participants	61 participants n=5 Participants
Albumin-corrected Calcium	11.80 mg/dL STANDARD_DEVIATION 0.48 • n=5 Participants	11.73 mg/dL STANDARD_DEVIATION 0.45 • n=7 Participants	11.77 mg/dL STANDARD_DEVIATION 0.46 • n=5 Participants
Intact Parathyroid Hormone (iPTH)	238.6 pg/mL STANDARD_DEVIATION 212.2 • n=5 Participants	179.0 pg/mL STANDARD_DEVIATION 98.0 • n=7 Participants	209.7 pg/mL STANDARD_DEVIATION 168.4 • n=5 Participants
Bisphosphonate Use Yes	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Bisphosphonate Use No	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)

Population: Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet n=33 Participants Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP	0.0 percentage of participants	75.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet n=33 Participants Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP	5.9 percentage of participants	84.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

Population: Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet n=33 Participants Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP	-1.66 percent change Standard Error 0.99	-15.21 percent change Standard Error 1.00

SECONDARY outcome

Timeframe: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Cinacalcet n=31 Participants Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP	-1.01 percent change Standard Error 4.05	-23.80 percent change Standard Error 4.18

Adverse Events

Double-blind Phase: Placebo

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Double-blind Phase: Cinacalcet

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Open-label Phase: Previous Placebo

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Open-label Phase: Previous Cinacalcet

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Double-blind Phase: Placebo n=34 participants at risk Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.	Double-blind Phase: Cinacalcet n=33 participants at risk Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.	Open-label Phase: Previous Placebo n=29 participants at risk Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.	Open-label Phase: Previous Cinacalcet n=28 participants at risk Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Cardiac disorders Coronary artery occlusion	2.9% 1/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperparathyroidism primary	2.9% 1/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.0% 1/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.0% 1/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.0% 1/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	2.9% 1/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	2.9% 1/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.0% 1/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.0% 1/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathy peripheral	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.6% 1/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	2.9% 1/34 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/33 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 1/29 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/28 • 60 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.