Trial Outcomes & Findings for To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan (NCT NCT02162771)

Last Updated: 2020-01-29

Results Overview

AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

Core Cycle 4 (Week 12)

Results posted on

2020-01-29

Participant Flow

A total of 184 participants were screened for the study. Of those, 44 participants failed screening and 140 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	CT-P10 Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Core Study Period (Part 2) STARTED	70	70
Core Study Period (Part 2) COMPLETED	62	62
Core Study Period (Part 2) NOT COMPLETED	8	8
Maintenance Study Period (Part 2) STARTED	62	60
Maintenance Study Period (Part 2) COMPLETED	46	38
Maintenance Study Period (Part 2) NOT COMPLETED	16	22

Reasons for withdrawal

Reasons for withdrawal
Measure	CT-P10 Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Core Study Period (Part 2) Progressive Disease	2	3
Core Study Period (Part 2) Adverse Event	4	1
Core Study Period (Part 2) Withdrawal by Subject	1	2
Core Study Period (Part 2) Physician Decision	0	2
Core Study Period (Part 2) Death	1	0
Maintenance Study Period (Part 2) Progressive Disease	11	13
Maintenance Study Period (Part 2) Adverse Event	3	3
Maintenance Study Period (Part 2) Death	2	1
Maintenance Study Period (Part 2) Withdrawal by Subject	0	3
Maintenance Study Period (Part 2) Protocol Violation	0	1
Maintenance Study Period (Part 2) Stable Disease	0	1

Baseline Characteristics

To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT-P10 n=70 Participants Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=70 Participants Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Total n=140 Participants Total of all reporting groups
Age, Continuous	57.0 years n=5 Participants	58.5 years n=7 Participants	57.5 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Core Cycle 4 (Week 12)

Population: Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.

Outcome measures

Outcome measures
Measure	CT-P10 n=50 Participants Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=56 Participants Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Area Under the Serum Concentration-time Curve at Steady State (AUCtau)	41002.43 h*ug/mL Standard Error 1.136	40099.08 h*ug/mL Standard Error 1.143

PRIMARY outcome

Timeframe: Core Cycle 4 (Week 12)

Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.

Outcome measures

Outcome measures
Measure	CT-P10 n=53 Participants Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=56 Participants Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Maximum Serum Concentration at Steady State (Cmax,ss)	256.19 ug/mL Standard Error 1.115	254.49 ug/mL Standard Error 1.120

PRIMARY outcome

Timeframe: During the Core Study Period (up to 8 cycles; Week 24)

Population: Efficacy population consisted of all patients who had at least 1 response evaluation after receiving at least 1 treatment cycle in the Core Study Period without any major protocol deviation that was relevant to the efficacy endpoint in Part 2.

ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: \>=50% decrease in SPD of target lesions and no evidence of disease progression.

Outcome measures

Outcome measures
Measure	CT-P10 n=66 Participants Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=68 Participants Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria	64 Participants	63 Participants

SECONDARY outcome

Timeframe: Cycles 1 to 8 during the Core Study Period

Population: Pharmacodynamic (PD) population consisted of all patients who had at least 1 posttreatment PD result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) without any major protocol deviation that was relevant to the PD endpoint in Part 2.

B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).

Outcome measures

Outcome measures
Measure	CT-P10 n=70 Participants Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=70 Participants Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 1 (Predose)	92.5 cells/uL Interval 20.0 to 2890.0	62.0 cells/uL Interval 20.0 to 2890.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 1 (1 hour after the end of infusion)	20.0 cells/uL Interval 20.0 to 1108.0	20.0 cells/uL Interval 20.0 to 51.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 2 (Predose)	20.0 cells/uL Interval 20.0 to 1750.0	20.0 cells/uL Interval 20.0 to 2890.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 3 (Predose)	20.0 cells/uL Interval 20.0 to 231.0	20.0 cells/uL Interval 20.0 to 35.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 4 (Predose)	20.0 cells/uL Interval 20.0 to 51.0	20.0 cells/uL Interval 20.0 to 20.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 5 (Predose)	20.0 cells/uL Interval 20.0 to 20.0	20.0 cells/uL Interval 20.0 to 20.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 6 (Predose)	20.0 cells/uL Interval 20.0 to 33.0	20.0 cells/uL Interval 20.0 to 20.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 7 (Predose)	20.0 cells/uL Interval 20.0 to 24.0	20.0 cells/uL Interval 20.0 to 20.0
B-cell Kinetics (B-cell Depletion and Recovery) Core Cycle 8 (Predose)	20.0 cells/uL Interval 20.0 to 20.0	20.0 cells/uL Interval 20.0 to 20.0

Adverse Events

CT-P10

Serious events: 24 serious events

Other events: 58 other events

Deaths: 0 deaths

Rituxan

Serious events: 13 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Sung Hyun Kim

CELLTRION, Inc.

Phone: +82-32-850-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	CT-P10 n=70 participants at risk Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=70 participants at risk Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Vascular disorders Deep vein thrombosis	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Vascular disorders Hypertension	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Vascular disorders Peripheral ischaemia	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Vascular disorders Thrombophlebitis	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Immune system disorders Anaphylactic shock	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
General disorders Pyrexia	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Fracture	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Injury	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Post procedural fistula	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Investigations Liver function test abnormal	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Cardiac disorders Atrial fibrillation	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Cardiac disorders Tachycardia	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Anaemia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	4.3% 3/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Leukopenia	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Neutropenia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Pancytopenia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Constipation	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Diarrhea	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Ileus	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Small intestinal perforation	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Hepatobiliary disorders Cholecystitis	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Hypoalbuminaemia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Hypocalcaemia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Hypomagnesaemia	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Tumour lysis syndrome	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Abdominal infection	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Appendicitis	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Campylobacter gastroenteritis	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Encephalitis	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.

Other adverse events
Measure	CT-P10 n=70 participants at risk Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.	Rituxan n=70 participants at risk Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Vascular disorders Hypertension	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	4.3% 3/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Fracture	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Injury, poisoning and procedural complications Infusion related reaction	22.9% 16/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	27.1% 19/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Anaemia	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Blood and lymphatic system disorders Neutropenia	38.6% 27/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	28.6% 20/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Nervous system disorders Dizziness	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Nervous system disorders Headache	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Nervous system disorders Hypoaesthesia	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Nervous system disorders Neuropathy peripheral	14.3% 10/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	17.1% 12/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Nervous system disorders Paraesthesia	4.3% 3/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	11.4% 8/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
General disorders Asthenia	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	11.4% 8/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
General disorders Fatigue	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	11.4% 8/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
General disorders Oedema	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	4.3% 3/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
General disorders Pyrexia	4.3% 3/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Psychiatric disorders Insomnia	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Abdominal pain	11.4% 8/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	15.7% 11/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Constipation	17.1% 12/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	14.3% 10/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Diarrhoea	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	10.0% 7/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Nausea	12.9% 9/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	10.0% 7/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Gastrointestinal disorders Stomatitis	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Alopecia	14.3% 10/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 7/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Back pain	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	17.1% 12/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperglycaemia	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Fungal infection	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Influenza	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	5.7% 4/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Lower respiratory tract infection	10.0% 7/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	1.4% 1/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Sinusitis	7.1% 5/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	2.9% 2/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Upper respiratory tract infection	20.0% 14/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	25.7% 18/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Infections and infestations Urinary tract infection	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.	8.6% 6/70 • Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months). All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.