Trial Outcomes & Findings for GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy (NCT NCT01274182)

NCT ID: NCT01274182

Last Updated: 2018-01-24

Results Overview

Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 312 participants
• Primary outcome timeframe: From baseline to 24 weeks
• Results posted on: 2018-01-24

Participant Flow

Participant milestones

Measure	GP2013 GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Overall Study STARTED	133	87	92
Overall Study 24 Weeks	123	83	84
Overall Study COMPLETED	112	69	80
Overall Study NOT COMPLETED	21	18	12

Reasons for withdrawal

Measure	GP2013 GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Overall Study Unsatisfactory therapeutic effect	6	3	4
Overall Study Adverse Event	4	5	3
Overall Study Withdrawal by Subject	5	5	3
Overall Study Lost to Follow-up	2	3	1
Overall Study Protocol Violation	3	2	0
Overall Study Death	1	0	1

Baseline Characteristics

Analysis done on data of BMI available at the baseline visit.

Baseline characteristics by cohort

Measure	GP2013 n=133 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=87 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=92 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Total n=312 Participants Total of all reporting groups
Age, Continuous	54.42 years STANDARD_DEVIATION 11.779 • n=133 Participants	52.17 years STANDARD_DEVIATION 12.531 • n=87 Participants	54.95 years STANDARD_DEVIATION 10.750 • n=92 Participants	54.10 years STANDARD_DEVIATION 11.701 • n=312 Participants
Sex: Female, Male Female	111 Participants n=133 Participants	73 Participants n=87 Participants	78 Participants n=92 Participants	262 Participants n=312 Participants
Sex: Female, Male Male	22 Participants n=133 Participants	14 Participants n=87 Participants	14 Participants n=92 Participants	50 Participants n=312 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=133 Participants	1 Participants n=87 Participants	0 Participants n=92 Participants	1 Participants n=312 Participants
Race (NIH/OMB) Asian	12 Participants n=133 Participants	12 Participants n=87 Participants	0 Participants n=92 Participants	24 Participants n=312 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=133 Participants	0 Participants n=87 Participants	0 Participants n=92 Participants	1 Participants n=312 Participants
Race (NIH/OMB) Black or African American	1 Participants n=133 Participants	6 Participants n=87 Participants	6 Participants n=92 Participants	13 Participants n=312 Participants
Race (NIH/OMB) White	117 Participants n=133 Participants	68 Participants n=87 Participants	75 Participants n=92 Participants	260 Participants n=312 Participants
Race (NIH/OMB) More than one race	0 Participants n=133 Participants	0 Participants n=87 Participants	0 Participants n=92 Participants	0 Participants n=312 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=133 Participants	0 Participants n=87 Participants	11 Participants n=92 Participants	13 Participants n=312 Participants
Region of Enrollment Argentina	8 participants n=133 Participants	3 participants n=87 Participants	9 participants n=92 Participants	20 participants n=312 Participants
Region of Enrollment Austria	7 participants n=133 Participants	10 participants n=87 Participants	3 participants n=92 Participants	20 participants n=312 Participants
Region of Enrollment Turkey	4 participants n=133 Participants	1 participants n=87 Participants	2 participants n=92 Participants	7 participants n=312 Participants
Region of Enrollment Romania	9 participants n=133 Participants	8 participants n=87 Participants	6 participants n=92 Participants	23 participants n=312 Participants
Region of Enrollment Belgium	1 participants n=133 Participants	4 participants n=87 Participants	0 participants n=92 Participants	5 participants n=312 Participants
Region of Enrollment United States	10 participants n=133 Participants	0 participants n=87 Participants	19 participants n=92 Participants	29 participants n=312 Participants
Region of Enrollment Brazil	19 participants n=133 Participants	12 participants n=87 Participants	19 participants n=92 Participants	50 participants n=312 Participants
Region of Enrollment Italy	5 participants n=133 Participants	3 participants n=87 Participants	3 participants n=92 Participants	11 participants n=312 Participants
Region of Enrollment France	4 participants n=133 Participants	1 participants n=87 Participants	0 participants n=92 Participants	5 participants n=312 Participants
Region of Enrollment Germany	31 participants n=133 Participants	17 participants n=87 Participants	14 participants n=92 Participants	62 participants n=312 Participants
Region of Enrollment India	12 participants n=133 Participants	12 participants n=87 Participants	0 participants n=92 Participants	24 participants n=312 Participants
Region of Enrollment Spain	13 participants n=133 Participants	16 participants n=87 Participants	4 participants n=92 Participants	33 participants n=312 Participants
Region of Enrollment Russia	6 participants n=133 Participants	0 participants n=87 Participants	11 participants n=92 Participants	17 participants n=312 Participants
Region of Enrollment Hungary	3 participants n=133 Participants	0 participants n=87 Participants	1 participants n=92 Participants	4 participants n=312 Participants
Region of Enrollment Estonia	1 participants n=133 Participants	0 participants n=87 Participants	1 participants n=92 Participants	2 participants n=312 Participants
Body Mass Index (BMI)	27.37 kg/m2 STANDARD_DEVIATION 6.230 • n=133 Participants • Analysis done on data of BMI available at the baseline visit.	27.25 kg/m2 STANDARD_DEVIATION 6.000 • n=85 Participants • Analysis done on data of BMI available at the baseline visit.	29.66 kg/m2 STANDARD_DEVIATION 6.606 • n=92 Participants • Analysis done on data of BMI available at the baseline visit.	28.02 kg/m2 STANDARD_DEVIATION 6.353 • n=310 Participants • Analysis done on data of BMI available at the baseline visit.
Duration of Rheumatoid Arthritis(RA)	10.53 years STANDARD_DEVIATION 8.074 • n=133 Participants • Analysis done on data of Duration of RA available at the baseline visit	10.81 years STANDARD_DEVIATION 7.137 • n=86 Participants • Analysis done on data of Duration of RA available at the baseline visit	11.10 years STANDARD_DEVIATION 8.299 • n=92 Participants • Analysis done on data of Duration of RA available at the baseline visit	10.78 years STANDARD_DEVIATION 7.874 • n=311 Participants • Analysis done on data of Duration of RA available at the baseline visit
Number of patients having received 1, 2 or >2 TNF inhibitor therapies. 1	109 Participants n=133 Participants	70 Participants n=87 Participants	73 Participants n=92 Participants	252 Participants n=312 Participants
Number of patients having received 1, 2 or >2 TNF inhibitor therapies. 2	18 Participants n=133 Participants	16 Participants n=87 Participants	13 Participants n=92 Participants	47 Participants n=312 Participants
Number of patients having received 1, 2 or >2 TNF inhibitor therapies. >2	6 Participants n=133 Participants	1 Participants n=87 Participants	6 Participants n=92 Participants	13 Participants n=312 Participants
Disease Activity Score 28 joint count - C-reactive proteine (DAS28-CRP)	5.83 units on a scale STANDARD_DEVIATION 0.922 • n=132 Participants • Analysis done on data of DAS28-CRP available at the baseline visit	5.85 units on a scale STANDARD_DEVIATION 0.880 • n=87 Participants • Analysis done on data of DAS28-CRP available at the baseline visit	5.91 units on a scale STANDARD_DEVIATION 1.009 • n=91 Participants • Analysis done on data of DAS28-CRP available at the baseline visit	5.86 units on a scale STANDARD_DEVIATION 0.935 • n=310 Participants • Analysis done on data of DAS28-CRP available at the baseline visit
Dose of methotrexate at baseline	15.09 mg/week STANDARD_DEVIATION 4.856 • n=131 Participants • Analysis done on data of Methotrexate use available at the baseline visit	14.65 mg/week STANDARD_DEVIATION 5.154 • n=84 Participants • Analysis done on data of Methotrexate use available at the baseline visit	15.29 mg/week STANDARD_DEVIATION 4.888 • n=91 Participants • Analysis done on data of Methotrexate use available at the baseline visit	15.03 mg/week STANDARD_DEVIATION 4.939 • n=306 Participants • Analysis done on data of Methotrexate use available at the baseline visit
Anti-drug antibodies (ADA) Negative	132 Participants n=133 Participants	85 Participants n=87 Participants	87 Participants n=92 Participants	304 Participants n=312 Participants
Anti-drug antibodies (ADA) Positive	0 Participants n=133 Participants	2 Participants n=87 Participants	3 Participants n=92 Participants	5 Participants n=312 Participants
Anti-drug antibodies (ADA) Missing	1 Participants n=133 Participants	0 Participants n=87 Participants	2 Participants n=92 Participants	3 Participants n=312 Participants

PRIMARY outcome

Timeframe: From baseline to 24 weeks

Population: PK Analysis Set

Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169

Outcome measures

Measure	GP2013 n=124 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=79 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=80 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA	7627.44 day*mcg/mL Geometric Coefficient of Variation 38.60	6896.97 day*mcg/mL Geometric Coefficient of Variation 40.56	7536.89 day*mcg/mL Geometric Coefficient of Variation 40.28	—

SECONDARY outcome

Timeframe: From baseline to week 24

Population: PK Analysis Set

Maximum serum concentration (Cmax) after the first infusion of GP2013, MabThera and Rituxan in patients with RA. Samples collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169.

Outcome measures

Measure	GP2013 n=120 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=78 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=82 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA	361.53 mcg/mL Geometric Coefficient of Variation 40.82	319.80 mcg/mL Geometric Coefficient of Variation 42.75	335.88 mcg/mL Geometric Coefficient of Variation 42.65	—

SECONDARY outcome

Timeframe: 14 days

Population: PK analysis set

Area under the effect curve of percent change of peripheral B-cell count from baseline to Day 14 (AUEC(0-14d)) of GP2013, MabThera and Rituxan in patients with RA

Outcome measures

Measure	GP2013 n=110 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=76 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=80 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA	1226.53 % * day Geometric Coefficient of Variation 2.83	1201.15 % * day Geometric Coefficient of Variation 8.91	1240.57 % * day Geometric Coefficient of Variation 1.95	—

SECONDARY outcome

Timeframe: 24 weeks

Population: PP analysis set

Change from baseline in Disease Activity Score 28 joint count - C-reactive proteine DAS28(CRP) at Week 24.

In order to calculate the DAS28(CRP) the number of tender joints and swollen joints were assessed using 28-joint count (tender28 and swollen28).The patient's global assessment of disease activity (GH) measured on a Visual Analogue Scale (VAS from 0mm - best to 100mm - worst) was obtained.

DAS28(CRP) = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GH + 0.96 The DAS28(CRP) provides a number on a scale from 0 to 10 indicating the current activity of the RA, while lower values correspond with less disease activity. A decrease in DAS28 signifies a clinical improvement.

Outcome measures

Measure	GP2013 n=128 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=82 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=85 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I n=85 Participants This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Change From Baseline in DAS28(CRP) at Week 24	-2.07 units on a scale Standard Error 0.103	-2.23 units on a scale Standard Error 0.143	-1.99 units on a scale Standard Error 0.126	-2.16 units on a scale Standard Error 0.142

SECONDARY outcome

Timeframe: 24 weeks

Population: PP analysis set

A patient will be considered as improved according the ACR20 criteria

• at least 20 % improvement from baseline in tender joint count, using the 68-joint count
• at least 20 % improvement from baseline in swollen joint count, using the 66-joint count
• and at least 20% improvement from baseline in a least 3 of the following 5 measures:
• Patient's assessment of RA pain (VAS 100 mm)
• Patient's global assessment of disease activity (VAS 100 mm)
• Physician's global assessment of disease activity (VAS 100 mm)
• Patient self-assessed disability (Health Assessment Questionnaire disability index)
• Acute phase reactant (C-reactive protein or erythrocyte sedimentation rate)

Outcome measures

Measure	GP2013 n=119 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=76 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=80 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I n=78 Participants This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Number of Patients With ACR20 (CRP) Response	86 Participants	55 Participants	50 Participants	56 Participants

SECONDARY outcome

Timeframe: At week 24

Population: PP analysis set

In order to calculate the Clinical Disease Activity Index (CDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).

CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm)

Outcome measures

Measure	GP2013 n=119 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=80 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=78 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I n=75 Participants This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Summary of Disease Activity According to CDAI High disease activity	26 Participants	20 Participants	18 Participants	18 Participants
Summary of Disease Activity According to CDAI Moderate disease activity	45 Participants	32 Participants	24 Participants	26 Participants
Summary of Disease Activity According to CDAI Low disease activity	41 Participants	25 Participants	30 Participants	19 Participants
Summary of Disease Activity According to CDAI Remission	7 Participants	3 Participants	6 Participants	12 Participants

SECONDARY outcome

Timeframe: At week 24

Population: PP analysis set

In order to calculate the Simplified Disease Activity Index (SDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).

SDAI = CDAI + CRP (in mg/dL)

(CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm))

Outcome measures

Measure	GP2013 n=117 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=77 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=77 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I n=74 Participants This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Summary of Disease Activity According to SDAI High disease activity	20 Participants	15 Participants	13 Participants	15 Participants
Summary of Disease Activity According to SDAI Moderate disease activity	48 Participants	34 Participants	27 Participants	29 Participants
Summary of Disease Activity According to SDAI Low disease activity	41 Participants	26 Participants	31 Participants	18 Participants
Summary of Disease Activity According to SDAI Remission	8 Participants	2 Participants	6 Participants	12 Participants

SECONDARY outcome

Timeframe: At week 24

Population: PP analysis set

Present DAS28 ≤ 3.2 (low): good response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).

Present DAS28 > 3.2 to ≤ 5.1 (moderate): moderate response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).

Present DAS28 > 5.1 (high): moderate response (if improvement > 1.2), no response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).

Outcome measures

Measure	GP2013 n=116 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=77 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=76 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I n=75 Participants This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Participant Response as Assessed by EULAR Response Criteria Good response	0 Participants	0 Participants	0 Participants	0 Participants
Participant Response as Assessed by EULAR Response Criteria Moderate response	101 Participants	61 Participants	67 Participants	63 Participants
Participant Response as Assessed by EULAR Response Criteria No response	15 Participants	16 Participants	9 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion, an average of 1 year

Population: Patients with positive ADA results at randomization were excluded from analysis

Number of patients with at least one post-baseline Anti-Drug-Antibody (ADA) positive serum sample until the last study visit. Sampling was at Day 1, 29, 113, 169, 267, 365, optional visit 1 (could be at any time between day 169 - week 24 and day 365 - week 52 for patients, who received a 2nd treatment course) and optional visit 2 (only applicable for patients, who received a 2nd treatment course, 26 weeks thereafter, if this was after day 365 - week 52).

Outcome measures

Measure	GP2013 n=127 Participants GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=84 Participants MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=82 Participants Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	GP2013 Part I This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I. Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I
Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample	21 participants	18 participants	11 participants	—

Adverse Events

GP2013

Serious events: 16 serious events

Other events: 87 other events

Deaths: 1 deaths

MabThera

Serious events: 14 serious events

Other events: 56 other events

Deaths: 0 deaths

Rituxan

Serious events: 9 serious events

Other events: 60 other events

Deaths: 1 deaths

Serious adverse events

Measure	GP2013 n=133 participants at risk GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=87 participants at risk MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=92 participants at risk Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Blood and lymphatic system disorders Anaemia	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Blood and lymphatic system disorders Bone marrow failure	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Blood and lymphatic system disorders Pancytopenia	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Cardiac disorders Angina pectoris	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Cardiac disorders Acute myocardial infarction	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Cardiac disorders Myocardial infarction	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Cardiac disorders Sinus tachycardia	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Chest pain	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Lipogranuloma	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Multiple organ dysfunction syndrome	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Pyrexia	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Immune system disorders Drug hypersensitivity	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Abscess	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Atypical pneumonia	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Gastroenteritis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Groin abscess	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Klebsiella sepsis	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Lyme disease	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Pilonidal cyst	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Pneumonia	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Pneumonia haemophilus	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Purulent pericarditis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Pyelonephritis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Sepsis	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Septic shock	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Soft tissue infection	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Infusion related reaction	1.5% 2/133 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.2% 2/92 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.2% 2/92 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Bone fissure	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Overdose	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Tibia fracture	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Fistula	1.5% 2/133 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Arthritis	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.75% 1/133 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Syncope	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Cerebrovascular accident	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Ischaemic stroke	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Meningoradiculitis	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Seizure	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Psychiatric disorders Depression	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Psychiatric disorders Dissociative disorder	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Reproductive system and breast disorders Urogenital prolapse	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Vascular disorders Vasculitis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/92 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Vascular disorders Venous thrombosis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.

Other adverse events

Measure	GP2013 n=133 participants at risk GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	MabThera n=87 participants at risk MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)	Rituxan n=92 participants at risk Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Blood and lymphatic system disorders Leukopenia	0.75% 1/133 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Gastrointestinal disorders Nausea	6.8% 9/133 • Number of events 9 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.4% 3/87 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.4% 5/92 • Number of events 10 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Gastrointestinal disorders Diarrhoea	3.0% 4/133 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.4% 3/87 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Fatigue	4.5% 6/133 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
General disorders Pyrexia	1.5% 2/133 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.4% 3/87 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Nasopharyngitis	6.8% 9/133 • Number of events 12 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	9.8% 9/92 • Number of events 11 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Urinary tract infection	8.3% 11/133 • Number of events 12 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 7 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.2% 2/92 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Upper respiratory tract infection	4.5% 6/133 • Number of events 7 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	6.5% 6/92 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Bronchitis	3.8% 5/133 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Oral herpes	3.8% 5/133 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Sinusitis	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.4% 5/92 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Infections and infestations Respiratory tract infection	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.4% 3/87 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Injury, poisoning and procedural complications Infusion related reaction	3.0% 4/133 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.4% 3/87 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.2% 2/92 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Investigations Alanine aminotransferase increased	2.3% 3/133 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Metabolism and nutrition disorders Dyslipidaemia	1.5% 2/133 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.4% 5/92 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	4.5% 6/133 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	8.7% 8/92 • Number of events 14 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Musculoskeletal and connective tissue disorders Back pain	3.0% 4/133 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	4.6% 4/87 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Nervous system disorders Headache	4.5% 6/133 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 7 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	6.5% 6/92 • Number of events 10 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Psychiatric disorders Depression	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	0.00% 0/87 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 5/133 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	4.6% 4/87 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	7.6% 7/92 • Number of events 7 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/133 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 4 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Skin and subcutaneous tissue disorders Pruritus	3.8% 5/133 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	4.6% 4/87 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Skin and subcutaneous tissue disorders Rash	1.5% 2/133 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	6.9% 6/87 • Number of events 6 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	1.1% 1/92 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.
Vascular disorders Hypertension	3.8% 5/133 • Number of events 5 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	5.7% 5/87 • Number of events 8 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.	3.3% 3/92 • Number of events 3 • Treatment emergent adverse events (TEAEs) are reported for the entire study duration, which means at least 52 weeks for patients who completed the study. For patients, who received a second optional treatment course, which could be given at any time between week 24 and week 52 an additional follow-up period of 26 weeks after the first infusion of the second treatment course was required. These patients had respectively longer study duration of maximally 1.5 years.

Additional Information

Global Program Medical Director

Sandoz

Phone: +49 8024 476

Email: biopharma.clinicaltrials@sandoz.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
• Publication restrictions are in place

Restriction type: OTHER