Trial Outcomes & Findings for Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma (NCT NCT02268045)

Last Updated: 2019-09-26

Results Overview

Per International Working Group (IWG) revised criteria for Malignant Lymphomas (Cheson et al. 2007) and assessed by positron-emission tomography scan, or by computed tomography scan and/or magnetic resonance imaging if Positron Emission Tomography (PET) scan was not feasible. Tumor response was classified according to the International Working Group criteria, as Complete Remission (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; Partial Response (PR): At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses; Stable disease (SD) or; Progressive disease. Response rate was the sum of CR and PR.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

272 participants

Primary outcome timeframe

Tumor response assessed after Cycle 6 or at the end of treatment

Results posted on

2019-09-26

Participant Flow

An additional cohort of 16 patients was added (as per Iran local regulatory requirements) to the planned sample of 256 patients. The extension cohort of Iran was only considered for safety analysis.

Participant milestones

Participant milestones
Measure	RTXM83 Rituximab biosimilar (RTXM83) was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.	MabThera MabThera was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.
Overall Study STARTED	136	136
Overall Study COMPLETED	120	116
Overall Study NOT COMPLETED	16	20

Reasons for withdrawal

Reasons for withdrawal
Measure	RTXM83 Rituximab biosimilar (RTXM83) was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.	MabThera MabThera was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.
Overall Study Death	4	4
Overall Study Disease Progression	2	1
Overall Study Adverse Event	7	7
Overall Study Withdrawal by Subject	2	6
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	1

Baseline Characteristics

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RTXM83-CHOP n=136 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=136 Participants Patients treated with Rituximab in combination with CHOP chemotherapy	Total n=272 Participants Total of all reporting groups
Age, Continuous	49.0 years n=5 Participants	51.0 years n=7 Participants	51.0 years n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	77 Participants n=7 Participants	155 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	78 Participants n=7 Participants	153 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Initial disease stage (Ann Arbor Staging) Stage I (with bulky)	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Initial disease stage (Ann Arbor Staging) Stage II	64 Participants n=5 Participants	53 Participants n=7 Participants	117 Participants n=5 Participants
Initial disease stage (Ann Arbor Staging) Stage III	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Initial disease stage (Ann Arbor Staging) Stage IV	23 Participants n=5 Participants	32 Participants n=7 Participants	55 Participants n=5 Participants
Presence of extra nodal lesions No	88 Participants n=5 Participants	81 Participants n=7 Participants	169 Participants n=5 Participants
Presence of extra nodal lesions Yes	48 Participants n=5 Participants	55 Participants n=7 Participants	103 Participants n=5 Participants
Performance Status according to Eastern Cooperative Oncology Group (ECOG) 0	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Performance Status according to Eastern Cooperative Oncology Group (ECOG) 1	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Performance Status according to Eastern Cooperative Oncology Group (ECOG) Missing data	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age-adjusted International Prognostic Index (IPI) 0	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Age-adjusted International Prognostic Index (IPI) 1	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants
Age-adjusted International Prognostic Index (IPI) 2	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Tumor response assessed after Cycle 6 or at the end of treatment

Population: The Intent-to-treat (ITT) population and the Per Protocol (PP) population

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=122 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=117 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Response Rate (RR) Achieved After Cycle 6 With RTXM83 Plus CHOP Compared to the RR Obtained With Mabthera® Plus CHOP (R-CHOP) in Patients With DLBCL ITT : Response rate (CR+PR)	83.6 percentage of participants Interval 75.8 to 89.7	82.9 percentage of participants Interval 74.8 to 89.2
Response Rate (RR) Achieved After Cycle 6 With RTXM83 Plus CHOP Compared to the RR Obtained With Mabthera® Plus CHOP (R-CHOP) in Patients With DLBCL PP : Response rate (CR+PR)	84.7 percentage of participants Interval 76.6 to 90.8	81.7 percentage of participants Interval 72.9 to 88.6

SECONDARY outcome

Timeframe: Cycle 1 (first dose): Day 1 (pre-dose, mid-infusion), Day 8 and Day 15

Compare the pharmacokinetic (PK) parameter (AUC 0-∞) calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1) in a population PK model. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=127 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=123 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
AUC 0-∞ (h μg/mL) at Cycle 1 of RTXM83 and Mabthera®	44519 ng.h/mL Geometric Coefficient of Variation 32	44874 ng.h/mL Geometric Coefficient of Variation 47

SECONDARY outcome

Timeframe: Cycle 6 (last dose): Day 1, Day 8, Day 15 and Day 21

Compare the PK parameter (AUC 0-∞) calculated from start of the first infusion until Day 21 of administration of Cycle 6 in a population PK model. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=113 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=105 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
AUC 0-∞ (h μg/mL) at Cycle 6 of RTXM83 and Mabthera®	60875 ng.h/mL Geometric Coefficient of Variation 22	59079 ng.h/mL Geometric Coefficient of Variation 40

SECONDARY outcome

Timeframe: Cycle 1 (first dose): Day 1 (pre-dose, mid-infusion), Day 8 and Day 15

Compare the PK parameter (Cmax) calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1) in a population PK model. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (Cmax) falls completely within the range 80%-125%.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=127 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=123 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Cmax (μg/mL) at Cycle 1 of RTXM83 and Mabthera®	196.8 μg/mL Geometric Coefficient of Variation 24	197.5 μg/mL Geometric Coefficient of Variation 31

SECONDARY outcome

Timeframe: Cycle 6 (last dose): Day 1, Day 8, Day 15 and Day 21

Compare the PK parameter (Cmax) calculated from start of the first infusion until Day 21 of administration of Cycle 6 in a population PK model. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=113 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=105 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Cmax (μg/mL) at Cycle 6 of RTXM83 and Mabthera®	291 μg/mL Geometric Coefficient of Variation 21	279 μg/mL Geometric Coefficient of Variation 36

SECONDARY outcome

Timeframe: Up to follow-up 3 (FU3); 9 months after last dose of treatment

Population: Data were provided for the number of samples available at each visit.

CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. To compare the percent Change From Baseline ((Cycle 1 pre-dose) in pharmacodynamic markers (CD19+ and CD20+ Cells) in Peripheral Blood achieved in RTXM83 and Mabthera® arms at Cycle 1 end of infusion (EOI), 6 months and 9 months after last dose of treatment.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=77 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=74 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® Cycle 1 EOI, CD19+	-96.8 percentage change in cells Interval -100.0 to 10.0	-94.6 percentage change in cells Interval -100.0 to 525.0
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® At 6 months after last dose, CD19+	-95.7 percentage change in cells Interval -100.0 to 833.0	-98.3 percentage change in cells Interval -100.0 to 4380.0
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® At 9 months after last dose, CD19+	-33 percentage change in cells Interval -100.0 to 13600.0	-42.3 percentage change in cells Interval -100.0 to 10300.0
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® Cycle 1 EOI, CD20+	-100 percentage change in cells Interval -100.0 to -16.7	-100 percentage change in cells Interval -100.0 to 7400.0
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® At 6 months after last dose, CD20+	-98.9 percentage change in cells Interval -100.0 to 700.0	-100 percentage change in cells Interval -100.0 to 6990.0
Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera® At 9 months after last dose, CD20+	-22.2 percentage change in cells Interval -100.0 to 69100.0	-30.6 percentage change in cells Interval -100.0 to 12400.0

SECONDARY outcome

Timeframe: Up to FU3; 9 months after last dose of treatment

Population: All patients receiving at least one dose of the study medication.

Compare the frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) reported in each treatment arm.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=136 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=136 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Comparable Safety Profile in Both Treatment Arms TEAEs related to treatment	125 Participants	119 Participants
Comparable Safety Profile in Both Treatment Arms At least one TEAE (any causality)	131 Participants	131 Participants
Comparable Safety Profile in Both Treatment Arms At least one grade 3/4 TEAE (any causality)	75 Participants	80 Participants
Comparable Safety Profile in Both Treatment Arms Serious TEAEs (any causality)	47 Participants	45 Participants
Comparable Safety Profile in Both Treatment Arms TEAE led to drug discontinuation (any causality)	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to FU3; 9 months after last dose of treatment

Anti-Drug Antibody (ADA) developed de novo (seroconversion) after 6 cycles of treatment and 9 months of follow-up.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=127 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=125 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Comparable Immunogenicity Profile Between RTXM83 and Mabthera® Seroconversion	3 Participants	4 Participants
Comparable Immunogenicity Profile Between RTXM83 and Mabthera® No seroconversion	124 Participants	121 Participants

SECONDARY outcome

Timeframe: Up to FU3; 9 months after last dose of treatment

Population: Number of patients with an EFS event (progressive disease, no achievement of CR, PR associated with treatment more than that per protocol, stable disease, relapse after achievement of CR, or death from any cause, whichever comes first).

Time from randomization to any of the following events: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, or death from any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	RTXM83-CHOP n=122 Participants Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=117 Participants Patients treated with Rituximab in combination with CHOP chemotherapy
Event Free Survival (EFS) in RTXM83 Arm and Mabthera® Arm	12.5 time (months) Interval 4.4 to Upper limit of the Confidence Interval was not achieved due to short time follow up	8.6 time (months) Interval 4.6 to Upper limit of the Confidence Interval was not achieved due to short time follow up

Adverse Events

RTXM83-CHOP

Serious events: 47 serious events

Other events: 131 other events

Deaths: 8 deaths

MabThera-CHOP

Serious events: 45 serious events

Other events: 131 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	RTXM83-CHOP n=136 participants at risk Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy	MabThera-CHOP n=136 participants at risk Patients treated with Rituximab in combination with CHOP chemotherapy
Blood and lymphatic system disorders Neutropenia	7.4% 10/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	5.9% 8/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Blood and lymphatic system disorders Leukopenia	4.4% 6/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	3.7% 5/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Gastrointestinal disorders Diarrhoea	2.9% 4/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
General disorders Pyrexia	3.7% 5/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	3.7% 5/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Infections and infestations Pneumonia	4.4% 6/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	3.7% 5/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Infections and infestations Septic shock	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Infections and infestations Lung infection	1.5% 2/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	0.74% 1/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Blood and lymphatic system disorders Febrile neutropenia	14.0% 19/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	5.1% 7/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Metabolism and nutrition disorders Dehydration	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Metabolism and nutrition disorders Hyponatremia	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	2.2% 3/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	1.5% 2/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.	1.5% 2/136 • Adverse event data were collected from the study start, during the study and up to 30 days after the end of study treatment. Graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC; version 4.0) and categorized using the MedDRA (version 16.0) terminology.

Other adverse events

Additional Information

Susana Millan

mAbxience

Phone: +34917711500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place