Trial Outcomes & Findings for Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis (NCT NCT01682512)
NCT ID: NCT01682512
Last Updated: 2018-01-30
Results Overview
The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.70\*ln(ESR) + 0.014\*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS \[score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)\]. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of \< 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2. The full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
294 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2018-01-30
Participant Flow
Subjects were enrolled into this multi-center, randomized, double-blind, parallel arm, multiple dose, active comparator 2 part trial from 27 September 2017. Trial was terminated on 3 September 2015 and last subject completed 28 October 2016.
509 subjects were screened for eligibility to participate in the trial. 293 subjects met all inclusion and exclusion criteria and were randomised to receive treatment. 6 subjects were included in an open-label safety run-in prior to randomisation in Part-I.
Participant milestones
| Measure |
BI 695500
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
111
|
66
|
|
Overall Study
Randomized in Part-I
|
66
|
65
|
66
|
|
Overall Study
Randomized in Part-II
|
50
|
46
|
0
|
|
Overall Study
COMPLETED
|
44
|
40
|
48
|
|
Overall Study
NOT COMPLETED
|
72
|
71
|
18
|
Reasons for withdrawal
| Measure |
BI 695500
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Study terminated by sponsor
|
46
|
43
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
3
|
2
|
|
Overall Study
Primary lack of efficacy
|
10
|
7
|
7
|
|
Overall Study
Secondary lack of efficacy
|
1
|
1
|
0
|
|
Overall Study
Other than stated above
|
2
|
4
|
2
|
Baseline Characteristics
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
BI 695500
n=116 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=110 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=65 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 10.46 • n=39 Participants
|
54.0 Years
STANDARD_DEVIATION 11.10 • n=41 Participants
|
54.8 Years
STANDARD_DEVIATION 12.22 • n=35 Participants
|
54.5 Years
STANDARD_DEVIATION 11.08 • n=31 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=39 Participants
|
96 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
242 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
49 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: FAS. Since this endpoint was designed to establish statistical equivalence of efficacy of BI 695500 and Rituxan®, only subjects randomized to BI 695500 and Rituxan® in part-I of study are included.
The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.70\*ln(ESR) + 0.014\*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS \[score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)\]. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of \< 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2. The full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit.
Outcome measures
| Measure |
BI 695500
n=58 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=61 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I
|
-1.8 Unit on scale
Interval -2.08 to -1.5
|
-1.4 Unit on scale
Interval -1.64 to -1.09
|
—
|
PRIMARY outcome
Timeframe: Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.Population: Pharmacokinetic analysis set (PKS) consisted of all randomized subjects who were PK evaluable based on protocol defined criteria.
Pharmacokinetic (PK) (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, determined over both dosages). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. As per protocol all the following criteria had to be fulfilled for a patient to be defined as PK evaluable for the Pharmacokinetic analysis set (PKS): Full first and second dose given. Pre-dose concentration available prior to the second dose. Ability to estimate AUC during the infusion phases. Ability to estimate the AUC for the distribution phase after the second dose. Ability to estimate the terminal half-life (t1/2) after the second dose. gMean - Geometric Mean
Outcome measures
| Measure |
BI 695500
n=56 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=56 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=55 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
PK (Part I Only): AUC0-tz (Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration, Determined Over Both Dosages)
|
171000 Hour(h)*Microgram(ug)/Milliliter (mL)
Geometric Coefficient of Variation 41.1
|
167000 Hour(h)*Microgram(ug)/Milliliter (mL)
Geometric Coefficient of Variation 40.5
|
193000 Hour(h)*Microgram(ug)/Milliliter (mL)
Geometric Coefficient of Variation 37.9
|
PRIMARY outcome
Timeframe: Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.Population: PKS
PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, determined over both dosages, and extrapolated to infinity using predicted last observed quantifiable concentration). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.
Outcome measures
| Measure |
BI 695500
n=56 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=56 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=54 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
PK (Part I Only): AUC0-inf Pred (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Determined Over Both Dosages)
|
174000 h*ug/mL
Geometric Coefficient of Variation 42.2
|
169000 h*ug/mL
Geometric Coefficient of Variation 42.0
|
202000 h*ug/mL
Geometric Coefficient of Variation 35.3
|
PRIMARY outcome
Timeframe: Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.Population: PKS
PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours after the first dose). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.
Outcome measures
| Measure |
BI 695500
n=56 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=56 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=55 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
PK (Part I Only): AUC0-336 (Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours)
|
49800 h*ug/mL
Geometric Coefficient of Variation 40.1
|
51900 h*ug/mL
Geometric Coefficient of Variation 28.9
|
55600 h*ug/mL
Geometric Coefficient of Variation 30.7
|
PRIMARY outcome
Timeframe: Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.Population: PKS
PK (Part I only): observed Cmax (observed maximum plasma concentration, determined after the second dose). Only subjects randomized in part I of this study are included.
Outcome measures
| Measure |
BI 695500
n=56 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=56 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=55 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
PK (Part I Only): Observed Cmax (Maximum Plasma Concentration, Determined After the Second Dose)
|
434 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 31.1
|
462 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 32.0
|
486 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 28.1
|
SECONDARY outcome
Timeframe: Week 24Population: FAS. Missing data have been imputed according to LOCF (last observation carried forward) and/or NRI (Non Responder Imputation).
A subject has an ACR20 response if all of the following occur: * a \> 20% improvement in the swollen joint count (66 joints) * a \> 20% improvement in the tender joint count (68 joints) * a \> 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (C-reactive protein). The percentage of subjects meeting the ACR20 response criteria at Week 24 (part-I and II) is presented for subjects randomised to receive BI 695500, Rituxan and MabThera.
Outcome measures
| Measure |
BI 695500
n=94 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=90 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=64 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II
|
26.6 Percentage of participants
|
23.3 Percentage of participants
|
56.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.Population: Pharmacokinetic full analysis set (PKFS) included all randomized subjects with at least one valid PK concentration measurement. A valid PK concentration measurement is a value greater than lower limit of quantification as provided by Charles River.
PK (Part I only): AUC0-inf, ppk. Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. A modeling approach was used to impute missing values as well as impute missing concentrations after the first dose with a sampling schedule identical to the first 2 weeks after the second dose. A unit dose of 1000 mg was used in calculating the imputed values. The resulting dataset thus consisted of PK evaluable and PK non-evaluable patients with both measured as well as imputed concentration values. The prediction of these concentrations was based on a mixed effect modeling approach and included significant covariates as identified during the PK model development (including age, body surface area \[BSA\], body mass index \[BMI\], weight, gender, race, and formulation).
Outcome measures
| Measure |
BI 695500
n=66 Participants
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=65 Participants
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=65 Participants
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
PK (Part I Only): AUC0-inf, Ppk (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Based on Individual Predicted Concentrations for Missing Data Derived From a Population PK Model, Determined Over Both Dosages)
|
165000 h*ug/mL
Geometric Coefficient of Variation 42.9
|
158000 h*ug/mL
Geometric Coefficient of Variation 50.0
|
180000 h*ug/mL
Geometric Coefficient of Variation 40.6
|
Adverse Events
BI 695500
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Rituxan®
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
MabThera®
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 695500
n=116 participants at risk
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=110 participants at risk
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=65 participants at risk
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.8%
2/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Immune system disorders
Anaphylactoid reaction
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Abscess neck
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Sepsis
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Septic shock
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.5%
1/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.8%
2/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.00%
0/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
Other adverse events
| Measure |
BI 695500
n=116 participants at risk
Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
Rituxan®
n=110 participants at risk
Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
MabThera®
n=65 participants at risk
Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
7.7%
5/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.9%
8/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
1.8%
2/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
9.2%
6/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
6.2%
4/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Nervous system disorders
Dizziness
|
0.86%
1/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
0.91%
1/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
6.2%
4/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Nervous system disorders
Headache
|
4.3%
5/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
6.4%
7/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
6.2%
4/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
3/116 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
2.7%
3/110 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
6.2%
4/65 • From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks
The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER