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    Clinical Trial Results:
    Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection

    Summary
    EudraCT number
    		 2016-000263-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Dec 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2016
    First version publication date
    09 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ML19849
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00337701
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 6912
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Dec 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To compare injection site reaction (ISR) signs and symptoms associated with enfuvirtide (ENF) injection using needle/syringe (NS) versus Biojector 2000 (B2000) needle-free injection device (NFID) based on a composite endpoint of grade 1-3 ongoing pain and either (a) grade 3-4 induration (≥25 mm) or (b) grade 2-4 nodules/cysts (>20 mm). • To compare the incidence and severity of individual clinical signs and symptoms of ISR associated with ENF injection using NS versus B2000 NFID.
    Protection of trial subjects
    All study subjects were required to read and sign an informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 317
    Worldwide total number of subjects
    317
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    309
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 349 subjects were enrolled at 42 centres in the United States. Out of 349 subjects, 317 subjects received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. These were included in the safety population and all analyses were performed on the safety population set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Biojector 2000
    Arm description
    		 Subjects self-administered enfuvirtide (ENF) using Biojector 2000 (B2000) from Day 1 through the end of the study (Day 57).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enfuvirtide (ENF)
    Investigational medicinal product code
    Other name
    Fuzeon
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enfuvirtide (ENF) 90 milligram (mg), subcutaneously (SC) twice daily (BID).

    Arm title
    		 First Needle/Syringe Then Biojector 2000
    Arm description
    		 Subjects self-administered ENF using needle/syringe (NS) from Day 1 through Day 28 followed by self-administration of ENF using B2000 from Day 29 up to Day 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enfuvirtide (ENF)
    Investigational medicinal product code
    Other name
    Fuzeon
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enfuvirtide (ENF) 90 mg, SC twice daily.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Injection site reaction (ISR) evaluator was blinded through Week 4.
    Number of subjects in period 1
    		Biojector 2000 First Needle/Syringe Then Biojector 2000
    Started
    213
    104
    Completed
    187
    97
    Not completed
    26
    7
         Withdrew Consent
    5
    1
         Adverse Event
    3
    1
         Injection Site Reaction
    11
    2
         Lost to follow-up
    2
    1
         Reason not Specified
    2
    1
         Difficulty With Injection Device
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Biojector 2000
    Reporting group description
    		 Subjects self-administered enfuvirtide (ENF) using Biojector 2000 (B2000) from Day 1 through the end of the study (Day 57).

    Reporting group title
    First Needle/Syringe Then Biojector 2000
    Reporting group description
    		 Subjects self-administered ENF using needle/syringe (NS) from Day 1 through Day 28 followed by self-administration of ENF using B2000 from Day 29 up to Day 57.

    Reporting group values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000 Total
    Number of subjects
    		 213 104 317
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.9 ± 7.6 46.5 ± 7.9 -
    Gender categorical
    Units: Subjects
        Female
    		 21 10 31
        Male
    		 192 94 286

    End points

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    End points reporting groups
    Reporting group title
    Biojector 2000
    Reporting group description
    		 Subjects self-administered enfuvirtide (ENF) using Biojector 2000 (B2000) from Day 1 through the end of the study (Day 57).

    Reporting group title
    First Needle/Syringe Then Biojector 2000
    Reporting group description
    		 Subjects self-administered ENF using needle/syringe (NS) from Day 1 through Day 28 followed by self-administration of ENF using B2000 from Day 29 up to Day 57.

    Primary: Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Baseline

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    End point title
    		 Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Baseline [1]
    End point description
    Subjects with any injection site reaction (ISR) with grade 1-3 ongoing pain and either grade 3-4 induration (greater than or equal to [≥] 25 millimeters [mm]) or grade 2-4 nodules/cysts (>20 mm). Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not performed for this endpoint.
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    212
    104
    Units: percentage of subjects
        number (not applicable)
    40.1
    36.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Week 4

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    End point title
    		 Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Week 4
    End point description
    Subjects with any ISR with grade 1-3 ongoing pain and either grade 3-4 induration (≥25 mm) or grade 2-4 nodules/cysts (>20 mm). Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 4
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    205
    102
    Units: percentage of subjects
        number (not applicable)
    25.4
    45.1
    Statistical analysis title
    		 Composite Tolerability Endpoint
    Comparison groups
    Biojector 2000 v First Needle/Syringe Then Biojector 2000
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0003 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P value was based on Cochran-Mantel-Haenszel test using randomization strata on week 4 data.

    Primary: Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Week 8

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    End point title
    		 Percentage of Subjects With the Composite Tolerability Endpoint (Painful Induration or Nodules/Cysts) at Week 8 [3]
    End point description
    Subjects with any ISR with grade 1-3 ongoing pain and either grade 3-4 induration (≥25 mm) or grade 2-4 nodules/cysts (>20 mm). Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not performed for this endpoint.
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    184
    92
    Units: percentage of subjects
        number (not applicable)
    21.2
    26.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Baseline

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    End point title
    		 Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Baseline [4]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not performed for this endpoint.
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    212
    104
    Units: percentage of subjects
    number (not applicable)
        Any ISR: Grade 1
    80.2
    76.9
        Any ISR: Grade 2
    72.2
    69.2
        Any ISR: Grade 3
    54.2
    57.7
        Any ISR: Grade 4
    26.4
    26
        Any ISR: Any Grade
    88.7
    86.5
        Ongoing Pain/Discomfort: Grade 1
    53.8
    46.2
        Ongoing Pain/Discomfort: Grade 2
    24.5
    27.9
        Ongoing Pain/Discomfort: Grade 3
    1.4
    5.8
        Ongoing Pain/Discomfort: Any Grade
    64.2
    56.7
        Erythema: Grade 1
    31.6
    37.5
        Erythema: Grade 2
    32.1
    29.8
        Erythema: Grade 3
    21.7
    14.4
        Erythema: Grade 4
    2.8
    3.8
        Erythema: Any Grade
    57.5
    58.7
        Induration: Grade 1
    22.2
    28.8
        Induration: Grade 2
    38.7
    40.4
        Induration: Grade 3
    44.3
    43.3
        Induration: Grade 4
    25.5
    25
        Induration: Any Grade
    71.2
    75
        Pruritus: Grade 1
    19.3
    17.3
        Pruritus: Grade 2
    0.9
    0
        Pruritus: Any Grade
    19.3
    17.3
        Nodules/Cysts: Grade 1
    36.8
    31.7
        Nodules/Cysts: Grade 2
    29.7
    26
        Nodules/Cysts: Grade 3
    18.9
    17.3
        Nodules/Cysts: Grade 4
    1.4
    0
        Nodules/Cysts: Any Grade
    54.2
    47.1
        Ecchymosis: Grade 1
    15.1
    20.2
        Ecchymosis: Grade 2
    6.1
    7.7
        Ecchymosis: Grade 3
    3.8
    5.8
        Ecchymosis: Grade 4
    1.9
    1
        Ecchymosis: Any Grade
    24.5
    27.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Week 4

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    End point title
    		 Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Week 4 [5]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 4
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not performed for this endpoint.
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    205
    102
    Units: percentage of subjects
    number (not applicable)
        Any ISR: Grade 1
    74.1
    79.4
        Any ISR: Grade 2
    64.4
    74.5
        Any ISR: Grade 3
    46.8
    60.8
        Any ISR: Grade 4
    22.9
    23.5
        Any ISR: Any Grade
    85.9
    95.1
        Ongoing Pain/Discomfort: Grade 1
    40.5
    56.9
        Ongoing Pain/Discomfort: Grade 2
    16.1
    28.4
        Ongoing Pain/Discomfort: Grade 3
    2.4
    4.9
        Ongoing Pain/Discomfort: Any Grade
    47.3
    67.6
        Erythema: Grade 1
    34.1
    33.3
        Erythema: Grade 2
    21.5
    31.4
        Erythema: Grade 3
    11.7
    22.5
        Erythema: Grade 4
    4.4
    2.9
        Erythema: Any Grade
    49.8
    61.8
        Induration: Grade 1
    20.5
    28.4
        Induration: Grade 2
    37.6
    38.2
        Induration: Grade 3
    36.1
    48
        Induration: Grade 4
    19.5
    20.6
        Induration: Any Grade
    65.4
    75.5
        Pruritus: Grade 1
    7.8
    16.7
        Pruritus: Grade 2
    1
    1
        Pruritus: Any Grade
    8.3
    17.6
        Nodules/Cysts: Grade 1
    31.7
    29.4
        Nodules/Cysts: Grade 2
    19.5
    29.4
        Nodules/Cysts: Grade 3
    16.6
    18.6
        Nodules/Cysts: Grade 4
    0
    0
        Nodules/Cysts: Any Grade
    42.9
    48
        Ecchymosis: Grade 1
    22
    17.6
        Ecchymosis: Grade 2
    8.3
    10.8
        Ecchymosis: Grade 3
    6.8
    2
        Ecchymosis: Grade 4
    3.9
    2.9
        Ecchymosis: Any Grade
    28.8
    26.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Week 8

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    End point title
    		 Percentage of Subjects with Injection Site Reactions by Sign/Symptom and Grade at Week 8 [6]
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not performed for this endpoint.
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    184
    92
    Units: percentage of subjects
    number (not applicable)
        Any ISR: Grade 1
    67.9
    72.8
        Any ISR: Grade 2
    54.3
    55.4
        Any ISR: Grade 3
    44.6
    45.7
        Any ISR: Grade 4
    20.7
    19.6
        Any ISR: Any Grade
    79.9
    84.8
        Ongoing Pain/Discomfort: Grade 1
    32.6
    50
        Ongoing Pain/Discomfort: Grade 2
    14.1
    12
        Ongoing Pain/Discomfort: Grade 3
    1.6
    2.2
        Ongoing Pain/Discomfort: Any Grade
    37.5
    54.3
        Erythema: Grade 1
    31.5
    30.4
        Erythema: Grade 2
    22.3
    21.7
        Erythema: Grade 3
    11.4
    5.4
        Erythema: Grade 4
    3.8
    2.2
        Erythema: Any Grade
    48.4
    46.7
        Induration: Grade 1
    22.3
    18.5
        Induration: Grade 2
    30.4
    32.6
        Induration: Grade 3
    38.6
    35.9
        Induration: Grade 4
    17.4
    18.5
        Induration: Any Grade
    65.8
    65.2
        Pruritus: Grade 1
    8.7
    9.8
        Pruritus: Grade 2
    0.5
    0
        Pruritus: Any Grade
    8.7
    9.8
        Nodules/Cysts: Grade 1
    28.8
    23.9
        Nodules/Cysts: Grade 2
    17.4
    13
        Nodules/Cysts: Grade 3
    10.9
    7.6
        Nodules/Cysts: Grade 4
    0
    0
        Nodules/Cysts: Any Grade
    33.7
    31.5
        Ecchymosis: Grade 1
    27.7
    25
        Ecchymosis: Grade 2
    8.2
    9.8
        Ecchymosis: Grade 3
    3.8
    4.3
        Ecchymosis: Grade 4
    3.3
    2.2
        Ecchymosis: Any Grade
    32.6
    32.6
    No statistical analyses for this end point

    Secondary: Overall Injection Site Reaction Score at Baseline and Week 4 – Between- Subject Comparison

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    End point title
    		 Overall Injection Site Reaction Score at Baseline and Week 4 – Between- Subject Comparison
    End point description
    Injection site reaction (ISR) score is calculated for each individual sign/symptom as Σgini, where i = 1 to the total number of ISRs, g = grade (ie, 1-3 for ongoing pain and pruritus and 1-4 for all others), and n = frequency. The individual scores were summed to give an overall total ISR score for each visit. The maximum possible overall score for a single ISR is 22. Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint and 'n'=number of subjects who were evaluated at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    213
    104
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n=212, 104)
    20.2 ± 19.8
    19.7 ± 18.8
        Week 4 (n=205, 102)
    15.3 ± 15.99
    19.2 ± 14.77
    No statistical analyses for this end point

    Secondary: Overall Injection Site Reaction Score at Baseline and Post-baseline in the Needle/Syringe to Biojector 2000 Group – Within-Subject Comparison

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    End point title
    		 Overall Injection Site Reaction Score at Baseline and Post-baseline in the Needle/Syringe to Biojector 2000 Group – Within-Subject Comparison
    End point description
    Injection site reaction (ISR) score is calculated for each individual sign/symptom as Σgini, where i = 1 to the total number of ISRs, g = grade (ie, 1-3 for ongoing pain and pruritus and 1-4 for all others), and n = frequency. The individual scores were summed to give an overall total ISR score for each visit. The maximum possible overall score for a single ISR is 22. Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint and 'n'=number of subjects who were evaluated at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    91
    91
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Baseline
    19 ± 18.06
    19 ± 18.06
        Week 4 (Needle/Syringe)/Week 8 (Biojector 2000)
    19 ± 14.21
    11.4 ± 10.27
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Discontinuing with Injection Site Reactions Leading to Discontinuation

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    End point title
    		 Percentage of Subjects Discontinuing with Injection Site Reactions Leading to Discontinuation
    End point description
    Injection site reactions leading to discontinuation were tabulated and listed by device used at the time of discontinuation. Safety analysis set included all subjects who received at least 1 dose of study medication and completed at least 1 post-baseline safety assessment on the randomized device. A post-baseline assessment is defined as any clinical evaluation for adverse events, local injection site reactions or death reported after the first dose of study medication. Here, number of subjects analysed is the total number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to 8 weeks
    End point values
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Number of subjects analysed
    213
    104
    Units: percentage of subjects
        number (not applicable)
    6.1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline up to Week 8
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Biojector 2000
    Reporting group description
    		 Subjects self-administered enfuvirtide (ENF) using Biojector 2000 (B2000) from Day 1 through the end of the study (Day 57).

    Reporting group title
    First Needle/Syringe Then Biojector 2000
    Reporting group description
    		 Subjects self-administered ENF using needle/syringe (NS) from Day 1 through Day 28 followed by self-administration of ENF using B2000 from Day 29 up to Day 57.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only selected safety data were collected, which included serious adverse events (SAEs), serious AIDS-defining events, discontinuations (of ENF and/or the injection device), adverse events of special interest, and AEs needed to clarify SAEs or discontinuations. Hence, non-serious adverse events were not collected.
    Serious adverse events
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 213 (2.82%)
    4 / 104 (3.85%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 213 (0.00%)
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Streptococcal sepsis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Biojector 2000 First Needle/Syringe Then Biojector 2000
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 104 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Oct 2006
    1. The protocol was amended primarily to capture all adverse events (AEs) that may be related to injection devices. These AEs are referred to as ‘adverse events of special interest’ and are defined as any device-related (B2000 or needle/syringe) AE other than the expected signs or symptoms of localized ISRs. 2. The amended protocol provided examples of the types of AEs to be reported, and investigators were asked to only record adverse events that could be considered related to the injection device.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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