Trial Outcomes & Findings for STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients (NCT NCT00364845)

Last Updated: 2014-05-21

Results Overview

The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Week 24

Results posted on

2014-05-21

Participant Flow

Participants were enrolled from 21 September 2006 through 6 November 2007

Participant milestones

Participant milestones
Measure	Darbepoetin Alfa Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Overall Study STARTED	28	23
Overall Study COMPLETED	17	12
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Darbepoetin Alfa Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	8	8
Overall Study Lost to Follow-up	0	1
Overall Study Death	0	1

Baseline Characteristics

STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Darbepoetin Alfa n=28 Participants Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=23 Participants Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.	Total n=51 Participants Total of all reporting groups
Age, Continuous	79.2 Years STANDARD_DEVIATION 4.9 • n=5 Participants	81.0 Years STANDARD_DEVIATION 5.1 • n=7 Participants	80.0 Years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Subset of Full Analysis Set, composed of all randomized participants with available data.

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=19 Participants Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=18 Participants Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24	51.4 Units on a scale Standard Error 1.6	46.7 Units on a scale Standard Error 2.8

SECONDARY outcome

Timeframe: Evaluation Period (Weeks 22-36)

Population: Subset of Full Analysis Set, composed of all randomized participants with available data

Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=20 Participants Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=18 Participants Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L	19 Participants	7 Participants

SECONDARY outcome

Timeframe: Evaluation Period (Weeks 22-36)

Population: Subset of Full Analysis Set, composed of all randomized participants with available data

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=20 Participants Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=18 Participants Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Mean Hemoglobin During the Evaluation Period	125.85 g/L Interval 121.84 to 129.86	104.50 g/L Interval 99.35 to 109.65

SECONDARY outcome

Timeframe: Week 24

Population: Subset of Full Analysis Set, composed of all randomized participants with available data

The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=19 Participants Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=16 Participants Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24	0.763 Units on a scale Interval 0.683 to 0.844	0.712 Units on a scale Interval 0.598 to 0.826

Adverse Events

Darbepoetin Alfa

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 18 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 aftercompletion. 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	Darbepoetin Alfa n=28 participants at risk Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=23 participants at risk Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Cardiac disorders Acute myocardial infarction	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina unstable	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Adrenal mass	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Duodenal ulcer	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Mallory-Weiss syndrome	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophagitis	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arthritis bacterial	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infection	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lobar pneumonia	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lower respiratory tract infection	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Encephalitis	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Measure	Darbepoetin Alfa n=28 participants at risk Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.	Placebo n=23 participants at risk Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Blood and lymphatic system disorders Anaemia	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 4/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lower respiratory tract infection	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	14.3% 4/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Excoriation	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Skin laceration	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations C-reactive protein increased	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Gout	10.7% 3/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 5/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 4/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	10.7% 3/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 4/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lethargy	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Paraesthesia	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 1/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 3/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	7.1% 2/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	10.7% 3/28 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 2/23 • Up to 46 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.