Trial Outcomes & Findings for A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma (NCT NCT02809053)
NCT ID: NCT02809053
Last Updated: 2020-10-08
Results Overview
Overall Response Rate (ORR) (Complete Response \[CR\] + Partial Response \[PR\]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
315 participants
Primary outcome timeframe
Baseline (Day 0) to Week 28.
Results posted on
2020-10-08
Participant Flow
One hundred and one study centres in 29 countries participated in the study. The first participant was enrolled into the study on the 18 January 2017 and the last participant completed week 28 (primary analysis cut-off) on the 17 July 2019.
A total of 455 participants were consented for the study and 315 participants were randomized in a 1:1 ration to receive SAIT101 (n=157) versus MabThera (n=158).
Participant milestones
| Measure |
SAIT101
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
158
|
|
Overall Study
Completed Treatment
|
156
|
156
|
|
Overall Study
COMPLETED
|
150
|
152
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
SAIT101
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Disease Progression
|
2
|
1
|
Baseline Characteristics
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 12.38 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 12.78 • n=107 Participants
|
58.1 years
STANDARD_DEVIATION 12.57 • n=206 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=99 Participants
|
9 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
26 participants
n=99 Participants
|
24 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=99 Participants
|
22 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
France
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Panama
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
India
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Guatemala
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Belarus
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Philippines
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Height (cm)
|
165.96 cm
STANDARD_DEVIATION 9.436 • n=99 Participants
|
165.71 cm
STANDARD_DEVIATION 10.650 • n=107 Participants
|
165.84 cm
STANDARD_DEVIATION 10.048 • n=206 Participants
|
|
Weight at baseline (kg)
|
73.80 kg
STANDARD_DEVIATION 15.107 • n=99 Participants
|
73.54 kg
STANDARD_DEVIATION 16.602 • n=107 Participants
|
73.67 kg
STANDARD_DEVIATION 15.850 • n=206 Participants
|
|
Body Mass Index (kg/m^2)
|
26.76 kg/m^2
STANDARD_DEVIATION 4.857 • n=99 Participants
|
26.66 kg/m^2
STANDARD_DEVIATION 4.967 • n=107 Participants
|
26.71 kg/m^2
STANDARD_DEVIATION 4.905 • n=206 Participants
|
|
Body Surface Area (m^2)
|
1.812 m^2
STANDARD_DEVIATION 0.2032 • n=99 Participants
|
1.807 m^2
STANDARD_DEVIATION 0.2332 • n=107 Participants
|
1.810 m^2
STANDARD_DEVIATION 0.2184 • n=206 Participants
|
|
Disease Duration (Years)
|
0.937 years
STANDARD_DEVIATION 2.1528 • n=99 Participants
|
0.934 years
STANDARD_DEVIATION 2.5793 • n=107 Participants
|
0.935 years
STANDARD_DEVIATION 2.3726 • n=206 Participants
|
|
Females of childbearing potential
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Eastern Co-operative Oncology Group (ECOG) performance status
ECOG Score 0
|
132 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
|
Eastern Co-operative Oncology Group (ECOG) performance status
ECOG Score 1
|
25 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Antidrug Antibody (ADA) Status at Baseline
Positive
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Antidrug Antibody (ADA) Status at Baseline
Negative
|
138 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
286 Participants
n=206 Participants
|
|
Antidrug Antibody (ADA) Status at Baseline
Not available
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ann Arbor Staging
Stage I
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ann Arbor Staging
Stage II
|
39 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ann Arbor Staging
Stage III
|
72 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Ann Arbor Staging
Stage IV
|
45 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Type of Ann Arbor Staging
Clinical Stage (CS)
|
144 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
|
Type of Ann Arbor Staging
Pathological Stage (PS)
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Risk Groups According to Follicular Lymphoma International Prognostic Index (FLIP-2) Score
Low Risk (0 to 1 risk factors)
|
102 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Risk Groups According to Follicular Lymphoma International Prognostic Index (FLIP-2) Score
Intermediate Risk (2 risk factors)
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Risk Groups According to Follicular Lymphoma International Prognostic Index (FLIP-2) Score
High Risk (Greater than or equal to 3 risk factor
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 28.Population: Full Analysis Set (FAS)
Overall Response Rate (ORR) (Complete Response \[CR\] + Partial Response \[PR\]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Overall Response Rate (ORR) at Week 28
|
66.3 percentage of participants
Interval 58.64 to 73.87
|
70.6 percentage of participants
Interval 63.21 to 77.97
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Full Analysis Set (FAS)
Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Tumour assessments were assessed by central imaging review per the International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Overall Response Rate (ORR) at Week 12
|
59.6 percentage of participants
Interval 51.16 to 67.62
|
70.0 percentage of participants
Interval 61.99 to 77.2
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 12 and Week 28.Population: Full Analysis Set (FAS)
Efficacy Endpoint: Complete Response (CR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Complete Response (CR) at Weeks 12 and 28
CR at Week 12
|
39 Participants
|
37 Participants
|
|
Complete Response (CR) at Weeks 12 and 28
CR at Week 28
|
51 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 12 and Week 28.Population: Full Analysis Set (FAS)
Efficacy Endpoint: Partial Response (PR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Partial Response (PR) at Weeks 12 and 28
PR at Week 12
|
48 Participants
|
68 Participants
|
|
Partial Response (PR) at Weeks 12 and 28
PR at Week 28
|
47 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 12 and Week 28.Population: Full Analysis Set (FAS)
Efficacy endpoint: number of participants with Stable Disease (SD) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Stable Disease (SD) at Weeks 12 and 28
SD at Week 12
|
50 Participants
|
39 Participants
|
|
Stable Disease (SD) at Weeks 12 and 28
SD at Week 28
|
22 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)to Week 12 and Week 28.Population: Full Analysis Dataset (FAS)
Efficacy endpoint: number of participants with Progressive Disease (PD) at 12 and 28 Weeks. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Progressive Disease (PD) at 12 and 28 Weeks
PD at Week 12
|
4 Participants
|
1 Participants
|
|
Progressive Disease (PD) at 12 and 28 Weeks
PD at Week 28
|
20 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to time of event or up to a maximum of 32 weeks, whichever is soonerPopulation: Full Analysis Set (FAS)
Time to Event (TTE) is defined as the time of randomisation to the date when an event occurred for a maximum follow-up period of 32 weeks from baseline; an event is disease progression, death due to any cause, or the start of new treatment for follicular lymphoma, whichever comes first.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Time to Event (TTE)
|
23.50 Weeks
Standard Deviation 7.500
|
24.08 Weeks
Standard Deviation 6.767
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to dosing on Week 1 and Week 4Population: Pharmacokinetic Analysis Set (PAS)
Pharmacokinetic endpoint: truncated area under the concentration-time curve (AUC) over the first (Day 1) and fourth (Day 22) dosing intervals (AUC0 168,w1, AUC0-168,w4).
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Truncated Area Under the Concentration-time Curve (AUC) Over the First and Fourth Dosing Intervals (AUC0 168,w1, AUC0-168,w4).
AUC0-168, week 1
|
20140 H*µg/ml
Geometric Coefficient of Variation 18.7
|
19860 H*µg/ml
Geometric Coefficient of Variation 18.3
|
|
Truncated Area Under the Concentration-time Curve (AUC) Over the First and Fourth Dosing Intervals (AUC0 168,w1, AUC0-168,w4).
AUC0-168, week 4
|
41290 H*µg/ml
Geometric Coefficient of Variation 19.0
|
42600 H*µg/ml
Geometric Coefficient of Variation 19.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to dosing on Week 1 and Week 4Population: Pharmacokinetic Analysis Set (PAS)
Pharmacokinetic endpoint: maximum plasma concentration (Cmax, µg/ml ) after the first dose (Week 1) and the fourth dose (week 4) (Cmax,w1, Cmax,w4).
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Maximum Concentration (Cmax) After the First Dose and the Fourth Dose (Cmax,w1, Cmax,w4).
Cmax, week 1
|
199.3 µg/ml
Geometric Coefficient of Variation 22.1
|
200.6 µg/ml
Geometric Coefficient of Variation 27.5
|
|
Maximum Concentration (Cmax) After the First Dose and the Fourth Dose (Cmax,w1, Cmax,w4).
Cmax, week 4
|
333.6 µg/ml
Geometric Coefficient of Variation 22.8
|
336.2 µg/ml
Geometric Coefficient of Variation 20.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to dosing on Week 1 and Week 4Population: Pharmacokinetic Analysis Set (PAS)
Pharmacokinetic endpoint: accumulation ratio for the Area Under the Concentration Time Cure 0 to 168 hours (AUC0-168) obtained from the fourth dose (Week 4) versus the first dose (Week 1) (RAUC). Accumulation ratio, calculated for AUC0-168 as (AUC0 168,w4/AUC0 168,w1).
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Accumulation Ratio for AUC0-168 Obtained From the Fourth Dose Versus the First Dose (RAUC).
|
2.075 Ratio
Geometric Coefficient of Variation 17.2
|
2.137 Ratio
Geometric Coefficient of Variation 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to dosing on Week 1 and Week 4Population: Pharmacokinetic Analysis set (PAS)
Pharmacokinetic endpoint: accumulation ratio for maximum plasma (Cmax) ratio from the fourth dose on Week 4 versus the first dose of treatment on Week 1 (RCmax). Accumulation ratio, calculated for Cmax as (Cmax,w4/Cmax,w1).
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Accumulation Ratio for the Maximum Plasma Concentration (Cmax) From the Fourth Dose Versus the First Dose (RCmax).
|
1.706 Ratio
Geometric Coefficient of Variation 23.2
|
1.671 Ratio
Geometric Coefficient of Variation 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Days 1, 8, 15, 22 and 29Population: Pharmacokinetic Analysis Set (PAS)
Pharmacokinetic endpoint: trough plasma concentration (Ctrough) during the dosing phase on Days 1, 8, 15, 22, and 29. Concentrations at predose on Days 8, 15, and 22 (µg/mL) and the time equivalent to the predose on Day 29, obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough).
Ctrough Day 8
|
60.60 µg/ml
Geometric Coefficient of Variation 45.5
|
61.00 µg/ml
Geometric Coefficient of Variation 43.4
|
|
Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough).
Ctrough Day 15
|
108.1 µg/ml
Geometric Coefficient of Variation 26.0
|
107.3 µg/ml
Geometric Coefficient of Variation 32.0
|
|
Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough).
Ctrough Day 22
|
143 µg/ml
Geometric Coefficient of Variation 23.8
|
143.3 µg/ml
Geometric Coefficient of Variation 30.0
|
|
Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough).
Ctrough Day 29
|
181.7 µg/ml
Geometric Coefficient of Variation 22.1
|
190.4 µg/ml
Geometric Coefficient of Variation 26.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.Population: Pharmacodynamic Analysis Set (PDS)
Pharmacodynamic Endpoint: Arithmetic mean observed change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 1 Mean Change from Baseline
|
-128.0 cells/μL
Standard Deviation 115.71
|
-141.6 cells/μL
Standard Deviation 120.90
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 2 Mean Change from Baseline
|
-144.1 cells/μL
Standard Deviation 123.34
|
-146.8 cells/μL
Standard Deviation 138.76
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 3 Mean Change from Baseline
|
-142.8 cells/μL
Standard Deviation 122.63
|
-157.4 cells/μL
Standard Deviation 102.03
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 4 Mean Change from Baseline
|
-141.5 cells/μL
Standard Deviation 122.92
|
-141.2 cells/μL
Standard Deviation 102.03
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 5 Mean Change from Baseline
|
-140.0 cells/μL
Standard Deviation 120.74
|
-158.5 cells/μL
Standard Deviation 134.27
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 12 Mean Change from Baseline
|
-144.2 cells/μL
Standard Deviation 122.09
|
-160.1 cells/μL
Standard Deviation 134.09
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 20 Mean Change from Baseline
|
-140.8 cells/μL
Standard Deviation 117.98
|
-159.5 cells/μL
Standard Deviation 135.63
|
|
Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 28 Mean Change from Baseline
|
-136.6 cells/μL
Standard Deviation 122.80
|
-148.2 cells/μL
Standard Deviation 134.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.Population: Pharmacodynamic Analysis Set (PDS)
Pharmacodynamic Endpoint: percent change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 3 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-100.00 Percent change
Standard Deviation 0.000
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 1 % Change from Baseline
|
-89.02 Percent change
Standard Deviation 26.324
|
-95.58 Percent change
Standard Deviation 8.294
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 2 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-94.62 Percent change
Standard Deviation 1.230
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 4 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-100.00 Percent change
Standard Deviation 0.000
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 5 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-100.00 Percent change
Standard Deviation 0.000
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 12 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-100.00 Percent change
Standard Deviation 0.000
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 20 % Change from Baseline
|
-100.00 Percent change
Standard Deviation 0.000
|
-100.00 Percent change
Standard Deviation 0.000
|
|
Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
Week 28 % Change from Baseline
|
-97.42 Percent change
Standard Deviation 12.749
|
-100.00 Percent change
Standard Deviation 0.000
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.Population: Pharmacodynamic Analysis Set
Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data.
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w1 (cells*day/µL)
|
-946.0 cells*day/µL)
Standard Deviation 830.29
|
-1000 cells*day/µL)
Standard Deviation 891.82
|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w2 (cells*day/µL)
|
-987.2 cells*day/µL)
Standard Deviation 997.57
|
-1104 cells*day/µL)
Standard Deviation 947.68
|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w3 (cells*day/µL)
|
-944.8 cells*day/µL)
Standard Deviation 910.79
|
-1073 cells*day/µL)
Standard Deviation 930.95
|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w4 (cells*day/µL)
|
-956.3 cells*day/µL)
Standard Deviation 728.52
|
-1196 cells*day/µL)
Standard Deviation 1153.7
|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-w12 (cells*day/µL)
|
11330 cells*day/µL)
Standard Deviation 9854.1
|
-12280 cells*day/µL)
Standard Deviation 10185
|
|
Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-w28 (cells*day/µL)
|
-26370 cells*day/µL)
Standard Deviation 22794
|
-28860 cells*day/µL)
Standard Deviation 25439
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.Population: Pharmacodynamic Analysis Set
Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data. The time-normalized AUEC parameters presented were calculated by dividing the respective AUEC by the time interval used to calculate the AUEC.
Outcome measures
| Measure |
SAIT101
n=76 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=72 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w1, normalized (cells/µL)
|
-135.0 cells/µL
Standard Deviation 118.88
|
-142.1 cells/µL
Standard Deviation 125.23
|
|
Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w2, normalized (cells/µL)
|
-137.1 cells/µL
Standard Deviation 123.43
|
-155.1 cells/µL
Standard Deviation 133.38
|
|
Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w3, normalized (cells/µL)
|
-134.3 cells/µL
Standard Deviation 121.75
|
-155.7 cells/µL
Standard Deviation 135.47
|
|
Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-168,w4, normalized (cells/µL)
|
-138.7 cells/µL
Standard Deviation 121.62
|
-159.2 cells/µL
Standard Deviation 136.55
|
|
Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
AUEC0-w12, normalized (cells/µL)
|
-143.0 cells/µL
Standard Deviation 121.38
|
-158.7 cells/µL
Standard Deviation 133.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1 to Weeks 5, 12, 20 and 28.Population: Safety Analysis Set (SAS
Immunogenicity endpoint: incidence of antidrug antibodies (ADA) and Neutralising Antibody (NAb). Immunogenicity sampling was performed pre-dose at Day 1, weeks 2, 3 and 4 and at any time during the visits at weeks 5, 12, 20 and 28.
Outcome measures
| Measure |
SAIT101
n=152 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=156 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 1 (Baseline) ADA · Negative
|
138 Participants
|
148 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 1 (Baseline) ADA · Positive
|
3 Participants
|
2 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 1 (Baseline) NAb · Negative
|
3 Participants
|
2 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 1 (Baseline) NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 2 ADA · Negative
|
143 Participants
|
152 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 2 ADA · Positive
|
1 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 2 NAb · Negative
|
1 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 2 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 3 ADA · Negative
|
138 Participants
|
148 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 3 ADA · Positive
|
5 Participants
|
2 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 3 NAb · Negative
|
5 Participants
|
2 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 3 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 4 ADA · Negative
|
145 Participants
|
149 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 4 ADA · Positive
|
2 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 4 NAb · Negative
|
2 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 4 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 5 ADA · Negative
|
139 Participants
|
145 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 5 ADA · Positive
|
2 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 5 NAb · Negative
|
2 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 5 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 12 ADA · Negative
|
137 Participants
|
144 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 12 ADA · Positive
|
3 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 12 NAb · Negative
|
3 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 12 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 20 ADA · Negative
|
131 Participants
|
144 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 20 ADA · Positive
|
7 Participants
|
4 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 20 NAb · Negative
|
7 Participants
|
4 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 20 NAb · Positive
|
0 Participants
|
0 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 28 ADA · Negative
|
126 Participants
|
129 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 28 ADA · Positive
|
10 Participants
|
16 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 29 NAb · Negative
|
9 Participants
|
16 Participants
|
|
Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
Week 29 NAb · Positive
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.Population: Safety Analysis Set (SAS)
Exploratory pharmacodynamic endpoint: Mean (SD) Change from Baseline of Immunoglobulin (IgG) and immunoglobulin M (IgM) (mg/dL) by Scheduled Time for Each Treatment (Safety Analysis Set). Samples for IgG and IgM assessment were collected at Baseline and Weeks 1, 2, 3, 4, 5, 12, 20 and 28.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 2
|
-0.21 Mg/dL
Standard Deviation 132.687
|
-14.79 Mg/dL
Standard Deviation 132.64
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 3
|
-17.08 Mg/dL
Standard Deviation 157.848
|
-30.04 Mg/dL
Standard Deviation 124.814
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 4
|
-36.31 Mg/dL
Standard Deviation 132.326
|
-34.64 Mg/dL
Standard Deviation 156.790
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 5
|
-34.62 Mg/dL
Standard Deviation 162.748
|
-38.21 Mg/dL
Standard Deviation 170.758
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 12
|
-28.15 Mg/dL
Standard Deviation 159.898
|
-2.30 Mg/dL
Standard Deviation 202.017
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 20
|
-26.86 Mg/dL
Standard Deviation 189.937
|
-22.40 Mg/dL
Standard Deviation 173.420
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgG Week 28
|
-19.33 Mg/dL
Standard Deviation 200.69
|
8.70 Mg/dL
Standard Deviation 238.309
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 2
|
0.34 Mg/dL
Standard Deviation 18.018
|
4.60 Mg/dL
Standard Deviation 28.273
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 3
|
0.87 Mg/dL
Standard Deviation 25.092
|
2.12 Mg/dL
Standard Deviation 32.569
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 4
|
0.64 Mg/dL
Standard Deviation 31.836
|
0.03 Mg/dL
Standard Deviation 30.009
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 5
|
-1.91 Mg/dL
Standard Deviation 29.521
|
-2.02 Mg/dL
Standard Deviation 21.651
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 12
|
8.02 Mg/dL
Standard Deviation 37.876
|
9.12 Mg/dL
Standard Deviation 21.671
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 20
|
-12.94 Mg/dL
Standard Deviation 46.966
|
-14.35 Mg/dL
Standard Deviation 26.012
|
|
Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
IgM Week 28
|
-22.08 Mg/dL
Standard Deviation 29.200
|
-20.85 Mg/dL
Standard Deviation 37.475
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Week 28Population: Full Analysis Set (FAS)
Exploratory Efficacy Endpoint: Analyses of Tumor Response and Time to Event, as Determined by the Combined International Working Group (IWG) Criteria 2014, Lugano Classification and IWG Criteria 2007 (Central Assessment) (Full Analysis Set)
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Exploratory Analyses of Tumor Response and Time to Event
Progressive Disease (PD)
|
19 Participants
|
11 Participants
|
|
Exploratory Analyses of Tumor Response and Time to Event
Complete Response (CR)
|
53 Participants
|
50 Participants
|
|
Exploratory Analyses of Tumor Response and Time to Event
Partial Response (PR)
|
47 Participants
|
55 Participants
|
|
Exploratory Analyses of Tumor Response and Time to Event
Stable Disease (SD)
|
21 Participants
|
25 Participants
|
|
Exploratory Analyses of Tumor Response and Time to Event
Unknown (UKN)
|
1 Participants
|
2 Participants
|
|
Exploratory Analyses of Tumor Response and Time to Event
No Evidence of Disease (NED)
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Week 28Population: Full Analysis Set (FAS)
Exploratory Efficacy Endpoint: Overall Response Rate (ORR) at Week 28 by Region, Age, Gender and Anti-Drug antibody (ADA) status. ADA status through Week 28 is 'Positive' if 'Positive' at any time point, and 'Negative' if 'Negative' at all time points. The 95% CI (confidence interval) for overall response rate (ORR) was calculated using the Exact method. The results presented in this table are based on the non-responder imputed data.
Outcome measures
| Measure |
SAIT101
n=157 Participants
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
|
MabThera
n=158 Participants
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR European Union (%)
|
68.5 percentage of participants
Interval 57.96 to 77.77
|
70.2 percentage of participants
Interval 59.9 to 79.21
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR Other Region (%)
|
54.8 percentage of participants
Interval 41.03 to 66.3
|
57.8 percentage of participants
Interval 44.82 to 70.06
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR Age 10-60 years (%)
|
58.6 percentage of participants
Interval 47.55 to 69.08
|
70.6 percentage of participants
Interval 59.71 to 99.98
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR Age >60 years (%)
|
67.1 percentage of participants
Interval 54.88 to 77.91
|
58.9 percentage of participants
Interval 46.77 to 70.29
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR Gender Female (%)
|
72.1 percentage of participants
Interval 61.38 to 81.23
|
67.0 percentage of participants
Interval 56.21 to 76.7
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR Gender Male (%)
|
50.7 percentage of participants
Interval 38.56 to 62.78
|
62.9 percentage of participants
Interval 50.48 to 74.11
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR ADA Positive (%)
|
42.1 percentage of participants
Interval 20.25 to 66.5
|
57.1 percentage of participants
Interval 34.02 to 78.18
|
|
Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
ORR ADA Negative (%)
|
65.4 percentage of participants
Interval 56.68 to 73.44
|
66.7 percentage of participants
Interval 58.04 to 74.54
|
Adverse Events
SAIT101
Serious events: 3 serious events
Other events: 85 other events
Deaths: 0 deaths
MabThera
Serious events: 4 serious events
Other events: 70 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SAIT101
n=157 participants at risk
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
MabThera
n=158 participants at risk
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.64%
1/157 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.00%
0/158 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/157 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/157 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Infections and infestations
Cystitis klebsiella
|
0.64%
1/157 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.00%
0/158 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/157 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/157 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Nervous system disorders
Paraesthesia
|
0.64%
1/157 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.00%
0/158 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/157 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
Other adverse events
| Measure |
SAIT101
n=157 participants at risk
SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
MabThera
n=158 participants at risk
MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrpopenia
|
4.5%
7/157 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.63%
1/158 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
5/157 • Number of events 6 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
3.2%
5/158 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
6/157 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
2.5%
4/158 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
4/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
1.9%
3/158 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/157 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
2.5%
4/158 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/157 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
2.5%
4/158 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
General disorders
Fatigue
|
3.8%
6/157 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
4.4%
7/158 • Number of events 11 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
General disorders
Asthenia
|
2.5%
4/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
2.5%
4/158 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
General disorders
Pyrexia
|
2.5%
4/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
1.3%
2/158 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.5%
18/157 • Number of events 27 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
16.5%
26/158 • Number of events 30 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
3/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
2.5%
4/158 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Nervous system disorders
Headache
|
5.7%
9/157 • Number of events 10 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
1.3%
2/158 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
4/157 • Number of events 6 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
0.00%
0/158 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
4/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
1.9%
3/158 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
4/157 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
5.1%
8/158 • Number of events 8 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
|
Vascular disorders
Hypertension
|
2.5%
4/157 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
1.9%
3/158 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place