Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars (NCT NCT00892723)

Last Updated: 2012-10-11

Results Overview

Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

12 Months

Results posted on

2012-10-11

Participant Flow

Enrollment in the study began in June 2009 and was completed in September 2010. All patients were enrolled in dermatological medical clinics.

Participant milestones

Participant milestones
Measure	Low Dose AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	High Dose AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Overall Study STARTED	21	19	19
Overall Study COMPLETED	19	15	17
Overall Study NOT COMPLETED	2	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Dose AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	High Dose AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Overall Study Lost to Follow-up	1	3	1
Overall Study Withdrawal by Subject	1	1	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose n=21 Participants AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	High Dose n=19 Participants AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo n=19 Participants Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	19 Participants n=4 Participants	19 Participants n=27 Participants	59 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	37.1 years STANDARD_DEVIATION 11 • n=93 Participants	36.1 years STANDARD_DEVIATION 10.9 • n=4 Participants	37.5 years STANDARD_DEVIATION 12.4 • n=27 Participants	36.9 years STANDARD_DEVIATION 11.2 • n=483 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	25 Participants n=483 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	34 Participants n=483 Participants
Region of Enrollment United States	21 participants n=93 Participants	19 participants n=4 Participants	19 participants n=27 Participants	59 participants n=483 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=19 Participants This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for Placebo n=19 Participants This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 0.3 mg AZX100 This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 1 mg AZX100 This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 0.3 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 1 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 0.3 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 1 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores	23.29 Units on a scale Standard Deviation 15.06	24.11 Units on a scale Standard Deviation 14.75	21.33 Units on a scale Standard Deviation 11.36	18.53 Units on a scale Standard Deviation 10.07	23.47 Units on a scale Standard Deviation 8.78	18.33 Units on a scale Standard Deviation 10.00	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months

At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=19 Participants This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for Placebo n=19 Participants This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 0.3 mg AZX100 This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 1 mg AZX100 This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 0.3 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 1 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 0.3 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 1 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters	71.9 Millimeters Standard Deviation 21.2	77.0 Millimeters Standard Deviation 20.3	68.1 Millimeters Standard Deviation 23.3	56.1 Millimeters Standard Deviation 12.8	62.2 Millimeters Standard Deviation 10.9	54.3 Millimeters Standard Deviation 13.2	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months

This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=19 Participants This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for Placebo n=19 Participants This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo n=19 Participants This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 0.3 mg AZX100 n=21 Participants This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 1 mg AZX100 n=19 Participants This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo n=19 Participants This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 0.3 mg AZX100 n=21 Participants This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 1 mg AZX100 n=19 Participants This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo n=19 Participants This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 0.3 mg AZX100 n=21 Participants This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 1 mg AZX100 n=19 Participants This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)	27.71 Millimeters Standard Deviation 6.76	27.90 Millimeters Standard Deviation 7.67	27.51 Millimeters Standard Deviation 5.63	13.48 Millimeters Standard Deviation 4.82	15.67 Millimeters Standard Deviation 5.03	12.52 Millimeters Standard Deviation 4.28	-0.86 Millimeters Standard Deviation 1.09	-0.57 Millimeters Standard Deviation 0.62	-0.38 Millimeters Standard Deviation 0.12	2.01 Millimeters Standard Deviation 1.20	2.44 Millimeters Standard Deviation 1.36	1.74 Millimeters Standard Deviation 0.92	0.40 Millimeters Standard Deviation 0.40	0.51 Millimeters Standard Deviation 0.34	0.31 Millimeters Standard Deviation 0.25

SECONDARY outcome

Timeframe: 12 months

This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=19 Participants This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	PSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for Placebo n=19 Participants This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 0.3 mg AZX100 n=21 Participants This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	OSAS Results for 1 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo n=19 Participants This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 0.3 mg AZX100 n=21 Participants This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Minimum Elevation - 1 mg AZX100 n=19 Participants This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 0.3 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Maximum Elevation - 1 mg AZX100 This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 0.3 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.	Scar Mean Elevation - 1 mg AZX100 This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)	0.42 Millimeters cubed Standard Deviation 0.39	0.65 Millimeters cubed Standard Deviation 0.49	0.37 Millimeters cubed Standard Deviation 0.25	-0.04 Millimeters cubed Standard Deviation 0.06	-0.06 Millimeters cubed Standard Deviation 0.07	-0.06 Millimeters cubed Standard Deviation 0.05	0.45 Millimeters cubed Standard Deviation 0.39	0.71 Millimeters cubed Standard Deviation 0.53	0.43 Millimeters cubed Standard Deviation 0.23	—	—	—	—	—	—

Adverse Events

Low Dose

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

High Dose

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Low Dose n=21 participants at risk AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	High Dose n=19 participants at risk AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo n=19 participants at risk Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Musculoskeletal and connective tissue disorders Back Pain	9.5% 2/21 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 1 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Gastrointestinal disorders Diarrhea	0.00% 0/21 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	10.5% 2/19 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Nervous system disorders Headache	23.8% 5/21 • Number of events 12 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	21.1% 4/19 • Number of events 4 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	21.1% 4/19 • Number of events 6 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Immune system disorders Hypersensitivity	9.5% 2/21 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Erythema	28.6% 6/21 • Number of events 10 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	42.1% 8/19 • Number of events 14 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	26.3% 5/19 • Number of events 9 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Irritation	38.1% 8/21 • Number of events 13 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	26.3% 5/19 • Number of events 11 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	26.3% 5/19 • Number of events 8 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Pain	28.6% 6/21 • Number of events 15 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	57.9% 11/19 • Number of events 19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	42.1% 8/19 • Number of events 17 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Pruritus	19.0% 4/21 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	15.8% 3/19 • Number of events 4 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	21.1% 4/19 • Number of events 4 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Reaction	9.5% 2/21 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 1 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
General disorders Injection Site Urticaria	28.6% 6/21 • Number of events 11 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	47.4% 9/19 • Number of events 15 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	21.1% 4/19 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Infections and infestations Nasopharyngitis	9.5% 2/21 • Number of events 4 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 1 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	15.8% 3/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Gastrointestinal disorders Nausea	0.00% 0/21 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	10.5% 2/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Musculoskeletal and connective tissue disorders Pain in Extremity	9.5% 2/21 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	5.3% 1/19 • Number of events 1 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.
Infections and infestations Upper Respiratory Tract Infection	19.0% 4/21 • Number of events 6 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	10.5% 2/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.	21.1% 4/19 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 15 months.

Additional Information

Denise Lamon

Capstone Therapeutics

Phone: 800-937-5520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60