Trial Outcomes & Findings for Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects (NCT NCT00828204)
NCT ID: NCT00828204
Last Updated: 2014-06-03
Results Overview
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
Day 22
Results posted on
2014-06-03
Participant Flow
Recruitment occurred in the following stages: Main Study (Initial Subset and Main Subset enrolled), and Extension Study. Initial subset participants were withdrawn when the study was suspended. After a protocol amendment, the Main Subset participants were enrolled. Only those in the Main Subset had the option to participate in the Extension Study.
Participant milestones
| Measure |
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Main Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
|---|---|---|
|
Main Study: Prior to Study Suspension
STARTED
|
21
|
0
|
|
Main Study: Prior to Study Suspension
Completed Manual Injection
|
21
|
0
|
|
Main Study: Prior to Study Suspension
Continued With Autoinjector Injections
|
19
|
0
|
|
Main Study: Prior to Study Suspension
COMPLETED
|
7
|
0
|
|
Main Study: Prior to Study Suspension
NOT COMPLETED
|
14
|
0
|
|
Main Study: After Study Restart
STARTED
|
0
|
74
|
|
Main Study: After Study Restart
Completed Manual Injection
|
0
|
74
|
|
Main Study: After Study Restart
Continued With Autoinjector Injections
|
0
|
72
|
|
Main Study: After Study Restart
COMPLETED
|
0
|
71
|
|
Main Study: After Study Restart
NOT COMPLETED
|
0
|
3
|
|
Extension Study
STARTED
|
0
|
64
|
|
Extension Study
COMPLETED
|
0
|
61
|
|
Extension Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Main Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
|---|---|---|
|
Main Study: Prior to Study Suspension
Adverse Event
|
1
|
0
|
|
Main Study: Prior to Study Suspension
Subject Was Withdrawn
|
2
|
0
|
|
Main Study: Prior to Study Suspension
Study Suspension
|
11
|
0
|
|
Main Study: After Study Restart
Adverse Event
|
0
|
2
|
|
Main Study: After Study Restart
Noncompliance
|
0
|
1
|
|
Extension Study
Lost to Follow-up
|
0
|
1
|
|
Extension Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
Baseline characteristics by cohort
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=74 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=21 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=70 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector
|
89 percentage of participants
Interval 81.0 to 96.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 23Population: Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.
Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=18 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector
|
14 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)Population: Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.
The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=19 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
No Erythema
|
65 percentage of participants
|
95 percentage of participants
|
|
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
No Induration
|
86 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
No Tenderness
|
90 percentage of participants
|
79 percentage of participants
|
|
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
Normal Temperature
|
100 percentage of participants
|
100 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 8, Day 15, Day 22Population: Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.
Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=19 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Mean Score for Ease of Use Grading Scale
Day 1 (Manual Injection) n=72, 19
|
8.1 scores on a scale
Standard Deviation 2.64
|
7.4 scores on a scale
Standard Deviation 2.41
|
|
Mean Score for Ease of Use Grading Scale
Day 8 (Autoinjector) n= 72, 18
|
8.9 scores on a scale
Standard Deviation 1.96 • Interval 0.0 to 10.0
|
6.8 scores on a scale
Standard Deviation 3.39
|
|
Mean Score for Ease of Use Grading Scale
Day 15 (Autoinjector) n=71, 16
|
8.7 scores on a scale
Standard Deviation 2.47 • Interval 0.0 to 10.0
|
6.7 scores on a scale
Standard Deviation 3.07
|
|
Mean Score for Ease of Use Grading Scale
Day 22 (Autoinjector) n=70, 7
|
9.3 scores on a scale
Standard Deviation 1.87 • Interval 1.0 to 10.0
|
5.9 scores on a scale
Standard Deviation 3.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8, Day 15, Day 22Population: Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.
Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
Printed instructions, Day 8; n=68
|
93 percentage of participants
|
—
|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
DVD, Day 8; n=69
|
88 percentage of participants
|
—
|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
Printed instructions, Day 15; n=42
|
90 percentage of participants
|
—
|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
DVD, Day 15; n=10
|
90 percentage of participants
|
—
|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
Printed instructions, Day 22; n=24
|
92 percentage of participants
|
—
|
|
Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
DVD, Day 22; n=9
|
89 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.
Participants in the Initial Subset were asked to answer the question "How satisfied are you with the presentation of the autoinjector instructions?" on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied).
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=18 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Mean Score for Initial Subset on Autoinjector Instructions Grading Scale
|
9.5 scores on a scale
Standard Deviation 0.71
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 8, Day 15, Day 22Population: Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.
Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: "Did you have any difficulty with your injection?" The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented.
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector
Day 1 (Manual Injection); n=70
|
89 percentage of participants
|
—
|
|
Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector
Day 8 (Autoinjector); n=71
|
90 percentage of participants
|
—
|
|
Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector
Day 15 (Autoinjector); n=71
|
90 percentage of participants
|
—
|
|
Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector
Day 22 (Autoinjector); n=71
|
90 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 23Population: Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.
Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=70 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=18 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe
|
94 percentage of participants
|
53 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 8, Day 15, Day 22Population: Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.
Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).
Outcome measures
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=19 Participants
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Mean Pain Score After Injection
Day 8 (Autoinjector) n= 72, 18
|
1.0 scores on a scale
Standard Deviation 1.46 • Interval 0.0 to 7.0
|
1.9 scores on a scale
Standard Deviation 2.19
|
|
Mean Pain Score After Injection
Day 1 (Manual Injection) n=72, 19
|
1.7 scores on a scale
Standard Deviation 1.76
|
2.5 scores on a scale
Standard Deviation 2.87
|
|
Mean Pain Score After Injection
Day 15 (Autoinjector) n=71, 16
|
1.3 scores on a scale
Standard Deviation 1.64 • Interval 0.0 to 6.0
|
2.1 scores on a scale
Standard Deviation 1.95
|
|
Mean Pain Score After Injection
Day 22 (Autoinjector) n=70, 7
|
0.7 scores on a scale
Standard Deviation 1.13 • Interval 0.0 to 6.0
|
2.4 scores on a scale
Standard Deviation 2.99
|
Adverse Events
Avonex Single-Use Autoinjector: Main Subset
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Avonex Single-Use Autoinjector: Initial Subset
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Avonex Single-Use Autoinjector: Main Subset
n=72 participants at risk
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
|
Avonex Single-Use Autoinjector: Initial Subset
n=19 participants at risk
Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
|
|---|---|---|
|
Infections and infestations
Cystitis
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Acute Sinusitis
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Ear Infection
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Lyme Disease
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Sinusitis
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Infections and infestations
Viral Infection
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Psychiatric disorders
Anxiety
|
4.2%
3/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Psychiatric disorders
Bipolar Disorder
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Nervous system disorders
Hypoaesthesia
|
2.8%
2/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Eye disorders
Macular Degeneration
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Eye disorders
Ulcerative Keratitis
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Vascular disorders
Flushing
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Vascular disorders
Hypertension
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.8%
2/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Protrusion
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Pain
|
9.7%
7/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
21.1%
4/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Haematoma
|
8.3%
6/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Influenza Like Illness
|
4.2%
3/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Erythema
|
4.2%
3/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Haemorrhage
|
2.8%
2/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Induration
|
2.8%
2/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Injection Site Pruritus
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Oedema Peripheral
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Vessel Puncture Site Haematoma
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
General disorders
Vessel Puncture Site Pain
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Investigations
Body Temperature Increased
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.8%
2/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
1.4%
1/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
0.00%
0/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
|
Injury, poisoning and procedural complications
Needle Issue
|
0.00%
0/72 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER