Trial Outcomes & Findings for Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects (NCT NCT01260272)

NCT ID: NCT01260272

Last Updated: 2014-04-29

Results Overview

Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-04-29

Participant Flow

Recruitment for this study started around Dec 2010 and ended around April 2011. Subjects were selected from the PI's contact database and from advertisements

Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility

Participant milestones

Participant milestones
Measure	Alternative Snack Group This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Overall Study STARTED	17	32
Overall Study COMPLETED	15	30
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alternative Snack Group n=17 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=32 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants	20 Participants n=107 Participants	33 Participants n=206 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	12 Participants n=107 Participants	16 Participants n=206 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 1 • n=99 Participants	60.3 years STANDARD_DEVIATION 1 • n=107 Participants	60.57 years STANDARD_DEVIATION 1 • n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	19 Participants n=107 Participants	25 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	13 Participants n=107 Participants	24 Participants n=206 Participants
Region of Enrollment United States	17 participants n=99 Participants	32 participants n=107 Participants	49 participants n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.

Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=15 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=28 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Percent Change in Postprandial Glucose Levels	6.34 Percent change from baseline Standard Error 7.4	-9.83 Percent change from baseline Standard Error 3.64

PRIMARY outcome

Timeframe: 12 weeks

Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=14 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=31 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Percent Change in Fasting Glucose Levels	1.5 Percent change from baseline Interval -2.0 to 3.0	1.0 Percent change from baseline Interval -2.88 to 7.66

PRIMARY outcome

Timeframe: 12 weeks

Raisin versus snacks: percent change in body weight from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=14 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=31 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Percent Change in Body Weight	-0.67 Percent change from baseline Standard Error 0.47	0.16 Percent change from baseline Standard Error 0.44

SECONDARY outcome

Timeframe: 12 weeks

Raisin versus snacks: change in systolic blood pressure from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=14 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=30 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Change in Systolic Blood Pressure	1.71 mmHg Standard Error 2.43	-4.83 mmHg Standard Error 1.86

SECONDARY outcome

Timeframe: 12 weeks

Raisin versus snacks: change in diastolic blood pressure from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=15 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=31 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Change in Diastolic Blood Pressure	-1.87 mmHg Standard Error 2.14	-5.16 mmHg Standard Error 1.48

SECONDARY outcome

Timeframe: 12 weeks

Raisin versus snacks: change in hemoglobin A1c from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=14 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=30 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Change in Hemoglobin A1c	-.04 Percent change from baseline Standard Error 0.04	-0.12 Percent change from baseline Standard Error 0.04

SECONDARY outcome

Timeframe: 12 weeks

Raisin versus snacks: change in waist circumference from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=14 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=29 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Change in Waist Circumference	-1.59 cm Standard Error 0.52	-2.02 cm Standard Error 0.7

SECONDARY outcome

Timeframe: 12 weeks

Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12

Outcome measures

Outcome measures
Measure	Alternative Snack Group n=13 Participants This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=30 Participants This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Change in High Density Lipoprotein Cholesterol Levels	0.62 Percent change from baseline Standard Error 3.15	-5.63 Percent change from baseline Standard Error 2.08

Adverse Events

Alternative Snack Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Raisin Group

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Kathy Schmitz, Site Manager

L-MARC Research center

Phone: 502 214 3990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Alternative Snack Group n=17 participants at risk This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers	Raisin Group n=32 participants at risk This group will receive raisins to consume three times a day with meals Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
Metabolism and nutrition disorders Decreased hunger	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Excess Gas	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Increased frequency of stools	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Indigestion	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Constipation	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Cardiac disorders Worsening hypertension	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Endocrine disorders Diabetes Mellitus	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Diarrhea	11.8% 2/17 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	6.2% 2/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Nausea	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	6.2% 2/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Abdominal Pain	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	6.2% 2/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Worsening heartburn	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Gastrointestinal disorders Xerostomia	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
General disorders Allergic Rhinitis	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
General disorders Fluid retention	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
General disorders Flu-like symptoms	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
General disorders Vertigo	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
General disorders Pyrexia	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Hepatobiliary disorders Elevated liver enzymes	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Infections and infestations Sinusitis	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	6.2% 2/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Injury, poisoning and procedural complications Puncture wound	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Injury, poisoning and procedural complications Posterior head pain related to trauma	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Musculoskeletal and connective tissue disorders Muscle spasm	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Musculoskeletal and connective tissue disorders Left ankle pain	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Musculoskeletal and connective tissue disorders Strained muscle	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Musculoskeletal and connective tissue disorders Effusion to right elbow	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign uterine mass	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Renal and urinary disorders Bladder infection	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	12.5% 4/32 • Number of events 4 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Reproductive system and breast disorders Intermittent cough	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Reproductive system and breast disorders Chest congestion	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Skin and subcutaneous tissue disorders Contact dermatitis	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	6.2% 2/32 • Number of events 2 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Skin and subcutaneous tissue disorders Contusion	5.9% 1/17 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	0.00% 0/32 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Vascular disorders Brain hemorrhage	0.00% 0/17 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.	3.1% 1/32 • Number of events 1 • Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.