Trial Outcomes & Findings for Methotrexate-Inadequate Response Autoinjector Device Sub Study (NCT NCT01844895)
NCT ID: NCT01844895
Last Updated: 2015-07-23
Results Overview
Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Day 29, Day 113
Results posted on
2015-07-23
Participant Flow
Autoinjector Substudy initiated April 2013; completed July 2014. Those participating in the long term main (parent) study IM101-174 who received weekly open-label SC 125mg abatacept injections via prefilled syringe for at least 3 months and who did not participate in a previous device substudy were eligible to enroll in the autoinjector substudy.
Participant milestones
| Measure |
125 mg Abatacept (Autoinjector and Prefilled Syringe)
125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
|
|---|---|
|
Day 1 to Day 28 - Pre-filled Syringe
STARTED
|
120
|
|
Day 1 to Day 28 - Pre-filled Syringe
COMPLETED
|
117
|
|
Day 1 to Day 28 - Pre-filled Syringe
NOT COMPLETED
|
3
|
|
Day 29 - Day113 - Autoinjector
STARTED
|
117
|
|
Day 29 - Day113 - Autoinjector
COMPLETED
|
111
|
|
Day 29 - Day113 - Autoinjector
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
125 mg Abatacept (Autoinjector and Prefilled Syringe)
125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
|
|---|---|
|
Day 1 to Day 28 - Pre-filled Syringe
Adverse Event
|
1
|
|
Day 1 to Day 28 - Pre-filled Syringe
Withdrawal by Subject
|
1
|
|
Day 1 to Day 28 - Pre-filled Syringe
Clinic Closed
|
1
|
|
Day 29 - Day113 - Autoinjector
Adverse Event
|
1
|
|
Day 29 - Day113 - Autoinjector
Withdrawal by Subject
|
1
|
|
Day 29 - Day113 - Autoinjector
Difficulty using device
|
3
|
|
Day 29 - Day113 - Autoinjector
planned surgery
|
1
|
Baseline Characteristics
Methotrexate-Inadequate Response Autoinjector Device Sub Study
Baseline characteristics by cohort
| Measure |
125 mg Abatacept (Autoinjector and Prefilled Syringe)
n=117 Participants
Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
South America
|
100 participants
n=99 Participants
|
|
Region of Enrollment
North America
|
17 participants
n=99 Participants
|
|
Body Weight
<60 kilogram (kg)
|
28 participants
n=99 Participants
|
|
Body Weight
60 - 100 kg
|
83 participants
n=99 Participants
|
|
Body Weight
>100 kg
|
6 participants
n=99 Participants
|
|
Duration of Disease
|
6.0 years
n=99 Participants
|
|
Methotrexate (MTX) Dose at SubStudy Baseline
|
17.0 mg/wk
STANDARD_DEVIATION 6.0 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 29, Day 113Population: The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.
Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=88 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=88 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)
|
27.76 μg/mL
Interval 24.44 to 31.53
|
25.32 μg/mL
Interval 22.59 to 28.38
|
SECONDARY outcome
Timeframe: Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)Population: PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=95 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=78 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector
|
40.9 μg/mL
Geometric Coefficient of Variation 48
|
39.8 μg/mL
Geometric Coefficient of Variation 58
|
SECONDARY outcome
Timeframe: Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)Population: PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=95 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=78 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector
|
70.00 h
Interval 0.0 to 168.7
|
56.34 h
Interval 0.0 to 171.1
|
SECONDARY outcome
Timeframe: Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)Population: PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg\*h/mL
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=95 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=78 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector
|
5740 µg*h/mL
Geometric Coefficient of Variation 47
|
5643 µg*h/mL
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: Days 22, 29, 57, 85, 106, and 113Population: PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).
Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=108 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=105 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 22 (n=104, 0) Pre-filled Syringe Only
|
29.09 μg/mL
Geometric Coefficient of Variation 48
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for autoinjector on Days 22 and 29
|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 29 (n=108, 0) Pre-filled Syringe Only
|
30.58 μg/mL
Geometric Coefficient of Variation 51
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for autoinjector on Days 22 and 29
|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 57 (n=0,105) Autoinjector Only
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for prefilled syringe after Day 29
|
28.79 μg/mL
Geometric Coefficient of Variation 59
|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 85 (n=0,104) Autoinjector Only
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for prefilled syringe after Day 29
|
25.73 μg/mL
Geometric Coefficient of Variation 53
|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 106 (n=0, 91) Autoinjector Only
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for prefilled syringe after Day 29
|
30.42 μg/mL
Geometric Coefficient of Variation 56
|
|
Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Day 113 (n=0,100) Autoinjector Only
|
NA μg/mL
Geometric Coefficient of Variation NA
n=0 for prefilled syringe after Day 29
|
28.06 μg/mL
Geometric Coefficient of Variation 51
|
SECONDARY outcome
Timeframe: Days 29 and 113Population: A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.
Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.
Outcome measures
| Measure |
125 mg Abatacept SC Using Prefilled Syringe - Day 29
n=115 Participants
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
|
125 mg Abatacept SC Using Autoinjector - Day 113
n=103 Participants
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
|
|---|---|---|
|
Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.
CTLA4 and Possibly Ig
|
1 participants
|
1 participants
|
|
Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.
Ig and/or Junction
|
5 participants
|
2 participants
|
Adverse Events
Abatacept Via Autoinjector Only (Day 29 to End of Study)
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Abatacept Cumulative (Prefilled Syringe and Autoinjector)
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept Via Autoinjector Only (Day 29 to End of Study)
n=117 participants at risk
Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
|
Abatacept Cumulative (Prefilled Syringe and Autoinjector)
n=117 participants at risk
125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
|
|---|---|---|
|
Infections and infestations
HiNI Influenza
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Cardiac disorders
Myocardial Ischemia
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
Other adverse events
| Measure |
Abatacept Via Autoinjector Only (Day 29 to End of Study)
n=117 participants at risk
Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
|
Abatacept Cumulative (Prefilled Syringe and Autoinjector)
n=117 participants at risk
125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.0%
7/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
7.7%
9/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Pharyngitis
|
4.3%
5/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
4.3%
5/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.3%
5/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
5.1%
6/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Bronchitis
|
1.7%
2/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
2.6%
3/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Vascular disorders
Hypertension
|
1.7%
2/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
1.7%
2/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
1.7%
2/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
2.6%
3/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
1.7%
2/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Ear Infection
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Folliculitis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Impetigo
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Pharyngitis Bacterial
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Post Procedural Infection
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Sinusitis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Infections and infestations
Vaginal Infection
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Gastrointestinal disorders
Irritable Bowel syndrome
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
General disorders
Drug intolerance
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
General disorders
Injection site Hemorrhage
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
General disorders
Injection site pruritus
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Investigations
Transaminases Increased
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Nervous system disorders
Headache
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Vascular disorders
Hypotension
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Cardiac disorders
Tachycardia
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Immune system disorders
Seasonal Allergy
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Reproductive system and breast disorders
Postmenopausal hemorrhage
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
0.85%
1/117 • Day 1 of the substudy up to 56 days post the last autoinjector dose.
Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER