Trial Outcomes & Findings for Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease (NCT NCT00706849)

Last Updated: 2016-09-09

Results Overview

LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides \<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

124 participants

Primary outcome timeframe

Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

Results posted on

2016-09-09

Participant Flow

Two hundred and twenty-five patients were screened and 124 participants were randomized on Day 1 in a 2:1 ratio to receive mipomersen or placebo once a week for 26 weeks.

Participant milestones

Participant milestones
Measure	Placebo Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Treatment Period STARTED	41	83
Treatment Period Full Analysis Set	41	82
Treatment Period COMPLETED	41	73
Treatment Period NOT COMPLETED	0	10
Follow-up Period STARTED	3	28
Follow-up Period COMPLETED	3	25
Follow-up Period NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Treatment Period Adverse Event	0	9
Treatment Period Other	0	1
Follow-up Period Withdrawal by Subject	0	2
Follow-up Period Protocol non-compliance	0	1

Baseline Characteristics

Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=83 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.	Total n=124 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 9.3 • n=5 Participants	56.2 years STANDARD_DEVIATION 9.7 • n=7 Participants	56.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	33 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	50 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	39 participants n=5 Participants	81 participants n=7 Participants	120 participants n=5 Participants
Race/Ethnicity, Customized White	38 participants n=5 Participants	81 participants n=7 Participants	119 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Other race	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Body Mass Index (BMI)	30.25 kg/m^2 STANDARD_DEVIATION 3.79 • n=5 Participants	28.66 kg/m^2 STANDARD_DEVIATION 4.23 • n=7 Participants	29.18 kg/m^2 STANDARD_DEVIATION 4.14 • n=5 Participants
Waist/hip ratio	0.95 ratio STANDARD_DEVIATION 0.07 • n=5 Participants	0.93 ratio STANDARD_DEVIATION 0.08 • n=7 Participants	0.93 ratio STANDARD_DEVIATION 0.08 • n=5 Participants
Metabolic syndrome No	30 participants n=5 Participants	48 participants n=7 Participants	78 participants n=5 Participants
Metabolic syndrome Yes	11 participants n=5 Participants	35 participants n=7 Participants	46 participants n=5 Participants
Tobacco use Current	4 participants n=5 Participants	13 participants n=7 Participants	17 participants n=5 Participants
Tobacco use non-current	17 participants n=5 Participants	32 participants n=7 Participants	49 participants n=5 Participants
Tobacco use Never	20 participants n=5 Participants	38 participants n=7 Participants	58 participants n=5 Participants
Alcohol use Current	31 participants n=5 Participants	64 participants n=7 Participants	95 participants n=5 Participants
Alcohol use Non-current	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Alcohol use Never	3 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).

Population: The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point	5.17 percentage of Baseline Standard Deviation 18.02	-28.02 percentage of Baseline Standard Deviation 26.99

PRIMARY outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
LDL Cholesterol at Baseline and at the Primary Efficacy Time Point Baseline	142.9 mg/dL Standard Deviation 51.6	152.9 mg/dL Standard Deviation 48.7
LDL Cholesterol at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	146.4 mg/dL Standard Deviation 43.4	103.9 mg/dL Standard Deviation 33.0

SECONDARY outcome

Population: Full Analysis Set

Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point	7.02 percentage of baseline Standard Deviation 16.52	-26.31 percentage of baseline Standard Deviation 22.16

SECONDARY outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Apolipoprotein B at Baseline and at the Primary Efficacy Time Point Baseline	126.8 mg/dL Standard Deviation 33.2	132.8 mg/dL Standard Deviation 33.9
Apolipoprotein B at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	133.8 mg/dL Standard Deviation 32.6	95.0 mg/dL Standard Deviation 29.7

SECONDARY outcome

Population: Full Analysis Set

Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point	3.85 percentage of baseline Standard Deviation 12.84	-19.43 percentage of baseline Standard Deviation 19.25

SECONDARY outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Total Cholesterol at Baseline and at the Primary Efficacy Time Point Baseline	213.4 mg/dL Standard Deviation 54.6	225.3 mg/dL Standard Deviation 51.5
Total Cholesterol at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	219.0 mg/dL Standard Deviation 49.0	176.0 mg/dL Standard Deviation 35.9

SECONDARY outcome

Population: Full Analysis Set

Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point	3.74 percentage of baseline Standard Deviation 16.04	-25.05 percentage of baseline Standard Deviation 25.71

SECONDARY outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point Baseline	165.3 mg/dL Standard Deviation 54.5	175.5 mg/dL Standard Deviation 51.1
Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	168.2 mg/dL Standard Deviation 47.5	125.2 mg/dL Standard Deviation 37.8

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point	0.5 percentage of baseline Inter-Quartile Range 20.77 • Interval -16.2 to 17.9	-14.3 percentage of baseline Inter-Quartile Range 43.76 • Interval -32.7 to 9.7

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Triglycerides at Baseline and at the Primary Efficacy Time Point Baseline	100 mg/dL Inter-Quartile Range 53.3 • Interval 74.0 to 137.0	107 mg/dL Inter-Quartile Range 39.6 • Interval 85.0 to 137.0
Triglycerides at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	101 mg/dL Inter-Quartile Range 42.5 • Interval 76.0 to 139.0	89 mg/dL Inter-Quartile Range 70.1 • Interval 70.0 to 127.0

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point	0.0 percentage of baseline Inter-Quartile Range 15.10 • Interval -8.0 to 13.0	-21.1 percentage of baseline Inter-Quartile Range 24.22 • Interval -37.9 to 0.0

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point Baseline	53 mg/dL Inter-Quartile Range 56.2 • Interval 17.0 to 108.0	45 mg/dL Inter-Quartile Range 64.6 • Interval 13.0 to 93.0
Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	51 mg/dL Inter-Quartile Range 53.5 • Interval 18.0 to 108.0	35 mg/dL Inter-Quartile Range 55.3 • Interval 9.0 to 56.0

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point	0.0 percentage of baseline Inter-Quartile Range 20.11 • Interval -15.4 to 15.0	-13.8 percentage of baseline Inter-Quartile Range 45.70 • Interval -33.3 to 11.8

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point Baseline	20 mg/dL Inter-Quartile Range 9.5 • Interval 15.0 to 28.0	21 mg/dL Inter-Quartile Range 7.9 • Interval 17.0 to 27.0
Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	20 mg/dL Inter-Quartile Range 8.5 • Interval 15.0 to 28.0	18 mg/dL Inter-Quartile Range 14.6 • Interval 14.0 to 25.0

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point	-2.8 percentage of baseline Inter-Quartile Range 19.38 • Interval -13.1 to 13.1	-29.2 percentage of baseline Inter-Quartile Range 29.99 • Interval -46.8 to -13.7

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point Baseline	2.72 ratio Inter-Quartile Range 1.495 • Interval 2.51 to 3.34	2.99 ratio Inter-Quartile Range 1.353 • Interval 2.56 to 4.0
Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	2.95 ratio Inter-Quartile Range 1.337 • Interval 2.19 to 3.49	2.09 ratio Inter-Quartile Range 1.034 • Interval 1.52 to 3.0

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point	3.71 percentage of baseline Standard Deviation 8.70	-2.44 percentage of baseline Standard Deviation 14.22

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point Baseline	146.1 mg/dL Standard Deviation 24.9	150.7 mg/dL Standard Deviation 28.1
Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	151.5 mg/dL Standard Deviation 29.1	145.4 mg/dL Standard Deviation 27.9

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point	5.8 percentage of baseline Inter-Quartile Range 9.57 • Interval 0.0 to 11.5	2.5 percentage of baseline Inter-Quartile Range 18.04 • Interval -10.3 to 11.7

OTHER_PRE_SPECIFIED outcome

Population: Full Analysis Set

The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=82 Participants Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point Baseline	48 mg/dL Inter-Quartile Range 11.1 • Interval 41.0 to 53.0	47 mg/dL Inter-Quartile Range 13.6 • Interval 40.0 to 58.0
High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point Primary efficacy time point	51 mg/dL Inter-Quartile Range 13.5 • Interval 42.0 to 58.0	48 mg/dL Inter-Quartile Range 15.6 • Interval 40.0 to 58.0

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Mipomersen

Serious events: 6 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=41 participants at risk Participants received a placebo subcutaneous injection once a week for 26 weeks.	Mipomersen n=83 participants at risk Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Cardiac disorders Acute myocardial infarction	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Cardiac disorders Angina pectoris	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Cardiac disorders Coronary artery disease	2.4% 1/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Cardiac disorders Supraventricular tachycardia	2.4% 1/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
General disorders Chest pain	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
General disorders Non-cardiac chest pain	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/41 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	1.2% 1/83 • Up to Week 28 (2 weeks after last dose) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Other adverse events

Additional Information

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Phone: 617-252-7832

Results disclosure agreements

Principal investigator is a sponsor employee After the multicenter publication or 12 months after completion of the study the PI may publish the results of his/her data from the study. The PI shall provide the sponsor with an advance copy at least 60 days prior to planned submission and the Sponsor shall have 60 days to review (contracts have variable timeframes; maximum times are stated here). The sponsor may request the deletion of any confidential information, or a delay in submission for an additional period not to exceed 90 days.
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